Browsing by Author "Bennett, Gary G"
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Item Open Access Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology.(Obesity (Silver Spring, Md.), 2015-11) Svetkey, Laura P; Batch, Bryan C; Lin, Pao-Hwa; Intille, Stephen S; Corsino, Leonor; Tyson, Crystal C; Bosworth, Hayden B; Grambow, Steven C; Voils, Corrine; Loria, Catherine; Gallis, John A; Schwager, Jenifer; Bennett, Gary GObjective
To determine the effect on weight of two mobile technology-based (mHealth) behavioral weight loss interventions in young adults.Methods
Randomized, controlled comparative effectiveness trial in 18- to 35-year-olds with BMI ≥ 25 kg/m(2) (overweight/obese), with participants randomized to 24 months of mHealth intervention delivered by interactive smartphone application on a cell phone (CP); personal coaching enhanced by smartphone self-monitoring (PC); or Control.Results
The 365 randomized participants had mean baseline BMI of 35 kg/m(2) . Final weight was measured in 86% of participants. CP was not superior to Control at any measurement point. PC participants lost significantly more weight than Controls at 6 months (net effect -1.92 kg [CI -3.17, -0.67], P = 0.003), but not at 12 and 24 months.Conclusions
Despite high intervention engagement and study retention, the inclusion of behavioral principles and tools in both interventions, and weight loss in all treatment groups, CP did not lead to weight loss, and PC did not lead to sustained weight loss relative to Control. Although mHealth solutions offer broad dissemination and scalability, the CITY results sound a cautionary note concerning intervention delivery by mobile applications. Effective intervention may require the efficiency of mobile technology, the social support and human interaction of personal coaching, and an adaptive approach to intervention design.Item Open Access Comparing Self-Monitoring Strategies for Weight Loss: Does Developing Mastery Before Diet Tracking Enhance Engagement?(2018) Patel, Michele LanpherSelf-monitoring of dietary intake is a valuable component of behavioral weight loss treatment but engagement in self-monitoring declines quickly, resulting in suboptimal treatment outcomes. This dissertation examined a novel weight loss intervention that aims to lessen the decline in self-monitoring engagement by building mastery, self-efficacy, and self-regulatory skills—key constructs of behavior change—prior to self-monitoring diet. GoalTracker was a randomized controlled trial among 105 adults with overweight or obesity comparing three standalone 12-week weight loss interventions: (1) a Simultaneous arm with concurrent self-monitoring of weight and diet each day, along with weekly lessons, action plans, and tailored feedback via email; (2) a Sequential arm with the same components but that tracked only weight through week 4, then added diet tracking; and (3) an App-Only arm that only tracked diet, and did not receive additional behavior change components. All groups used the commercial app MyFitnessPal for self-monitoring and received a tailored calorie goal and a goal to lose 5% of initial weight by 12 weeks. Paper one examined the impact of the intervention on weight change and self-monitoring engagement (Aims 1-3) and found significant weight loss and engagement for all treatment arms, with no differences between arms. Paper two examined the relation between consistent self-monitoring and weight loss (Aim 4), revealing that consistent trackers lost significantly more weight than others. Lastly, paper three examined whether early weight loss predicts future engagement and weight loss success (Aim 5), which was supported. Regardless of the order in which diet is tracked, using tailored goals and a commercial app can produce clinically significant weight loss. Consistent self-monitoring and early weight loss should be emphasized. Standalone digital health treatments may be a viable option for those looking for a lower intensity approach.
Item Open Access Does perception equal reality? Weight misperception in relation to weight-related attitudes and behaviors among overweight and obese US adults(2011) Duncan, Dustin T; Wolin, Kathleen Y; Scharoun-Lee, Melissa; Ding, Eric L; Warner, Erica T; Bennett, Gary GBackground - Weight misperception might preclude the adoption of healthful weight-related attitudes and behaviors among overweight and obese individuals, yet limited research exists in this area. We examined associations between weight misperception and several weight-related attitudes and behaviors among a nationally representative sample of overweight and obese US adults. Methods - Data from the 2003-2006 National Health and Nutrition Examination Survey (NHANES) were used. Analyses included non-pregnant, overweight and obese (measured body mass index ≥ 25) adults aged 20 and older. Weight misperception was identified among those who reported themselves as "underweight" or "about the right weight". Outcome variables and sample sizes were: weight-loss attitudes/behaviors (wanting to weigh less and having tried to lose weight; n = 4,784); dietary intake (total energy intake; n = 4,894); and physical activity (meets 2008 US physical activity recommendations, insufficiently active, and sedentary; n = 5,401). Multivariable regression models were stratified by gender and race/ethnicity. Analyses were conducted in 2009-2010. Results - These overweight/obese men and women who misperceived their weight were 71% (RR 0.29, 95% CI 0.25-0.34) and 65% (RR 0.35, 95% CI 0.29-0.42) less likely to report that they want to lose weight and 60% (RR 0.40, 95% CI 0.30-0.52) and 56% (RR 0.44, 95% CI 0.32-0.59) less likely to have tried to lose weight within the past year, respectively, compared to those who accurately perceived themselves as overweight. Blacks were particularly less likely to have tried to lose weight. Weight misperception was not a significant predictor of total energy intake among most subgroups, but was associated with lower total energy intake among Hispanic women (change -252.72, 95% CI -433.25, -72.18). Men who misperceived their weight were less likely (RR 0.68, 95% CI 0.52-0.89) to be insufficiently active (the strongest results were among Black men) and women who misperceived their weight were less likely (RR 0.74, 95% CI 0.54, 1.00, p = 0.047) to meet activity recommendations compared to being sedentary. Conclusion - Overall, weight misperception among overweight and obese adults was associated with less likelihood of interest in or attempts at weight loss and less physical activity. These associations varied by gender and race/ethnicity. This study highlights the importance of focusing on inaccurate weight perceptions in targeted weight loss efforts.Item Open Access Erratum: Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology.(Obesity (Silver Spring, Md.), 2016-02) Svetkey, Laura P; Batch, Bryan C; Lin, Pao-Hwa; Intille, Stephen S; Corsino, Leonor; Tyson, Crystal C; Bosworth, Hayden B; Grambow, Steven C; Voils, Corrine; Loria, Catherine; Gallis, John A; Schwager, Jenifer; Bennett, Gary GItem Open Access Evaluating the Influence of Patient Caretakers’ Health Literacy on Delays in Care for Traumatic Brain Injury Patients at Mulago National Referral Hospital, Uganda.(2019-04-24) Nwosu, ChinemeremBackground Caretakers take on caregiving tasks such as feeding and administering oral medication for patients at Mulago National Referral Hospital (MNRH), Uganda and many Low-Middle Income Countries (LMICs) where nurse shortages are prevalent. They shoulder the burden of caretaking responsibilities with little or no knowledge of the patient care. Studies have shown that caretaker’s ability to navigate the healthcare system, find, and use health information to support their patients throughout the care continuum can impact the three delays in care: seeking, reaching and receiving care. With the life-threatening nature of Traumatic Brain Injuries (TBI) in Uganda, caretakers’ play an important role in ensuring patients access care in a timely manner. This study seeks to determine the factors that impact TBI patient caretakers’ health literacy in MNRH and examine how these factors influence the three delays in care. Methods This qualitative research study was carried out in the neurosurgical ward at MNRH, in northern Kampala. The study participants were 27 adult caretakers. Semi-structured in-depth qualitative interviews, outlined through “The Three Delay Framework”, was utilized to understand participants’ experiences with delays in seeking, reaching and receiving care for moderate to severe TBI patients. Thematic content analysis and manual coding was used to analyze interview transcripts and identify overarching themes in the participant responses. Results This study identified three main caretaker health literacy factors, each with three sub-factors, that impact the three delays to care. The main themes identified were Extrinsic, Intrinsic and Health System Factors. The nine sub-themes were Government Support, Community Support, Financial Burdens, Lack of Medical Resources, Access to Health Information, Physician Support, Emotional Challenges, Navigational Skills and Understanding of Health Information. These components were found to influence the delays to care to varying degrees. More importantly, Financial Burdens, Government Support, Emotional Challenges, Physician Support and Lack of Medical Resources were recurring health literacy factors across the three delays. Conclusion The health literacy factors identified in this study work to influence caretakers’ functional health literacy and the delays to care in a co-dependent manner. A better understanding of how these factors impact patient outcomes is necessary for the development of context and culturally relevant interventions targeted at improving a caretaker’s ability to maneuver the healthcare system and support patients in resource-poor settings. There is a strong need for the state and policy makers to invest in improving health education and communication strategies to support caretakers’ health literacy needs and mitigate the delays to care for TBI patients.Item Open Access Examining Patterns and Predictors of Diet Tracking via Mobile Technologies Among Women with Hypertension(2019) Christy, JacobBackground: Hypertension is a primary risk factor for cardiovascular disease. Studies have shown that hypertension may have a more severe effect on cardiovascular disease outcomes among women. To mitigate this risk of hypertension in women, evidence supports that the DASH (Dietary Approaches to Stop Hypertension) diet as an effective treatment. Despite decades of evidence supporting the efficacy of the DASH diet to treat hypertension, compliance to DASH remains consistently low across all populations. However, given the importance of self-monitoring for producing behavior change, innovative efforts that utilize this strategy are needed to improve adoption of DASH on a population level. Methods: This thesis is a secondary analysis of 3-month digital health intervention (DASH Cloud) to improve adoption of DASH among high risk women conducted in Durham, NC at Duke University. Participants (N= 59) were allocated into the DASH Cloud arm (N= 30), or the attention control arm (N = 29). Both groups received publicly available booklets about the DASH diet and were asked to self-monitor their diet using a commercially available diet tracking app. Only the intervention arm received personalized feedback about their compliance to the DASH diet and skills training videos via text message. The goal of this study was to understand patterns and predictors of self-monitoring via the diet tracking app. Results: Overall, the median proportion of self-monitoring engagement was 76%. By treatment arm, the median proportion of engagement in the DASH Cloud arm and attention control arm was 68% and 85%, respectively. Significant predictors of self-monitoring include those who had 100% engagement during the first two weeks and first month of the study, had marital support, lower BMI, at least a college degree, insurance, a negative perception of their food environment, were somewhat comfortable with using apps and less likely to use an app to track medication adherence. Conclusion: This study provided evidence that self-monitoring of diet is high within the context of an intervention aimed at using digital health to promote compliance to the DASH diet among high risk women. The strongest predictor of self-monitoring engagement was early engagement. This suggests that interventions aiming to improve rates of self-monitoring an improve uptake of DASH using diet tracking apps should aim to improve early engagement to achieve success overall. However, given the small sample size of the study, future studies should include a larger population to describe patterns of self-monitoring and ascertain other predictors of engagement.
Item Open Access Informing the Cultural Translation of a Weight loss Intervention for Overweight/Obese Adults in Beijing(2011) Sun, JianiObjectives: To inform the cultural translation of a US behavioral intervention (iOTA) for the Chinese population.
Methods: We conducted a systematic literature review, counseling Chinese collaborators' experiences, and conducted key informant interviews. 38 overweight/obese participants (BMI≥24) were recruited in Peking University Health Science Center and Peking University Third Hospital for the key informant interview. Only 20 (52.6%) participants (12 female, 8 male) who came to the face-to-face interview and complete the 20-minute survey were selected for data analysis. The interviews contained questions about weight loss history, weight related concerns and barriers during weight loss process, general lifestyles, and also inquiries of comments and acceptance for each iOTA goal and intervention approach.
Results: Physical activity and dieting are the primary options for weight loss. Health and lack of perseverance are the biggest weight loss concern and barrier. After tailoring by literature review, all of the tailored iOTA goal and intervention approaches had more than 80% acceptance except "Red meat no more than 1 time per week" with only 60% acceptance. 20% people found difficulty attending all of the 4 group sessions.
Conclusion: iOTA principle is largely accepted by Chinese population with proper cultural modification focusing on health concerns, perseverance, special eating habit, and social stress.
Keywords: Weight-loss, interventions, iOTA, cultural translation, key informant interview
Item Open Access Mobile health devices: will patients actually use them?(Journal of the American Medical Informatics Association : JAMIA, 2016-05) Shaw, Ryan J; Steinberg, Dori M; Bonnet, Jonathan; Modarai, Farhad; George, Aaron; Cunningham, Traven; Mason, Markedia; Shahsahebi, Mohammad; Grambow, Steven C; Bennett, Gary G; Bosworth, Hayden BAlthough mobile health (mHealth) devices offer a unique opportunity to capture patient health data remotely, it is unclear whether patients will consistently use multiple devices simultaneously and/or if chronic disease affects adherence. Three healthy and three chronically ill participants were recruited to provide data on 11 health indicators via four devices and a diet app. The healthy participants averaged overall weekly use of 76%, compared to 16% for those with chronic illnesses. Device adherence declined across all participants during the study. Patients with chronic illnesses, with arguably the most to benefit from advanced (or increased) monitoring, may be less likely to adopt and use these devices compared to healthy individuals. Results suggest device fatigue may be a significant problem. Use of mobile technologies may have the potential to transform care delivery across populations and within individuals over time. However, devices may need to be tailored to meet the specific patient needs.Item Open Access Physical activity in US Blacks: a systematic review and critical examination of self-report instruments.(Int J Behav Nutr Phys Act, 2010-10-08) Wolin, Kathleen Y; Fagin, Casey; Ufere, Nneka; Tuchman, Hallie; Bennett, Gary GBACKGROUND: Physical activity self-report instruments in the US have largely been developed for and validated in White samples. Despite calls to validate existing instruments in more diverse samples, relatively few instruments have been validated in US Blacks. Emerging evidence suggests that these instruments may have differential validity in Black populations. PURPOSE: This report reviews and evaluates the validity and reliability of self-reported measures of physical activity in Blacks and makes recommendations for future directions. METHODS: A systematic literature review was conducted to identify published reports with construct or criterion validity evaluated in samples that included Blacks. Studies that reported results separately for Blacks were examined. RESULTS: The review identified 10 instruments validated in nine manuscripts. Criterion validity correlations tended to be low to moderate. No study has compared the validity of multiple instruments in a single sample of Blacks. CONCLUSION: There is a need for efforts validating self-report physical activity instruments in Blacks, particularly those evaluating the relative validity of instruments in a single sample.Item Open Access Recruiting young adults into a weight loss trial: report of protocol development and recruitment results.(Contemp Clin Trials, 2013-07) Corsino, Leonor; Lin, Pao-Hwa; Batch, Bryan C; Intille, Stephen; Grambow, Steven C; Bosworth, Hayden B; Bennett, Gary G; Tyson, Crystal; Svetkey, Laura P; Voils, Corrine IObesity has spread to all segments of the U.S. population. Young adults, aged 18-35 years, are rarely represented in clinical weight loss trials. We conducted a qualitative study to identify factors that may facilitate recruitment of young adults into a weight loss intervention trial. Participants were 33 adults aged 18-35 years with BMI ≥25 kg/m(2). Six group discussions were conducted using the nominal group technique. Health, social image, and "self" factors such as emotions, self-esteem, and confidence were reported as reasons to pursue weight loss. Physical activity, dietary intake, social support, medical intervention, and taking control (e.g. being motivated) were perceived as the best weight loss strategies. Incentives, positive outcomes, education, convenience, and social support were endorsed as reasons young adults would consider participating in a weight loss study. Incentives, advertisement, emphasizing benefits, and convenience were endorsed as ways to recruit young adults. These results informed the Cellphone Intervention for You (CITY) marketing and advertising, including message framing and advertising avenues. Implications for recruitment methods are discussed.Item Open Access Reduction of Internalized Weight Bias via Mindful Self-compassion: Theoretical Framework and Results from a Randomized Controlled Trial(2022) Hopkins, ChristinaWeight bias internalization is considered a chronic discriminatory stressor and a threat to health. Weight bias internalization has known associations with health-depleting behaviors (i.e., disordered eating, social isolation) and avoidance of health-promoting behaviors (i.e., physical activity, adherence to healthcare guidelines). Despite the numerous deleterious health effects of weight bias internalization, relatively few efficacious interventions have been identified for this critical treatment target. Self-compassion training presents itself as a potential intervention, though has not been rigorously tested in those with elevated internalized weight bias. Ruby was a two-arm randomized control designed to reduce internalized weight bias. Ruby tested the efficacy of a 4-week digitally-delivered self-compassion intervention compared to wait list control. Participants in the intervention group received daily text messages which included psychoeducation videos, writing prompts, and guided mindfulness audio files to facilitate daily mindful self-compassion practices ranging from 4-21 minutes per day. The main outcome of this trial was the 4-week reduction in weight bias internalization as measured by the Weight Bias Internalization Scale, compared to wait list control. Trial outcomes were analyzed using linear mixed models and one-way analysis of covariance models using an intent-to-treat framework. Ruby participants were 121 adults with elevated internalized weight bias (i.e., WBIS score > 4.0) and a body mass index over 30 kg/m2. Participants in the intervention demonstrated greater reductions in weight bias internalization compared to the wait list control (Net difference: -0.84, CI: -1.21 to -0.48, p < .0001). Participants in the intervention demonstrated similar reductions in secondary outcomes, including weight self-stigma, weight-related experiential avoidance, and fear of self-compassion (p’s < .05). Additionally, they reported increases in self-compassion, mindfulness, body appreciation, intuitive eating, and physical activity. Mediation analyses suggest that reductions in weight bias internalization are likely partially driven by increases in self-compassion. Ruby was the first digital standalone self-compassion based intervention targeting weight bias internalization. Results suggest that a brief mindful self-compassion intervention can meaningfully reduce internalized weight bias over 4 weeks. Additionally, a mindful self-compassion intervention can reduce several other secondary outcomes related to internalized weight bias. Due to its standalone digital delivery, Ruby may be a highly-scalable treatment for internalized weight bias that can be delivered on its own or combined with other treatments. Ruby is poised to expand a burgeoning body of literature related to psychological intervention for internalized weight bias.
Item Open Access Social-Cognitive Determinants of Success in Online Communities for Weight Management(2016) Lane, Ilana BethBackground: Online communities may be an effective, convenient, and relatively inexpensive intervention platform for individuals seeking assistance with weight management. Recent research suggests that these communities may be as effective as in-person treatments for weight management; however, very little is known about the characteristics that predict weight loss amongst those using an online community. Methods: Within a social-cognitive framework, we sought to identify the psychosocial characteristics that are associated with successful weight management for users of MyFitnessPal, a popular online community for weight management. We recruited participants who were new to the online community and asked them to complete 2 surveys (one at baseline and one 3 months later) that assessed various psychosocial constructs as well as self-reported height and weight. Results: Participants in our sample reported losing, on average, 4.55 kg during the 3-month time period. We found that engaging in weight control behaviors (e.g., monitoring food intake, weighing oneself, etc.) fully mediated the relationship between several of our variables of interest (i.e., baseline self-efficacy and perceived social support within the community) and weight loss. We also found that participants who expected to lose more weight at baseline were significantly more likely to have lost more weight at follow-up. Conclusions: On average, participants in our study lost a clinically meaningful amount of weight. Predictors of weight loss within this community included perceived support within the community (mediated by weight control behaviors), baseline self-efficacy (mediated by weight control behaviors), and baseline outcome expectations. Results of this study can ultimately serve to inform the design of future eHealth interventions for weight management.
Item Open Access The Association Between Engagement and Weight Loss Through Personal Coaching and Cell Phone Interventions in Young Adults: Randomized Controlled Trial (Preprint)(2018-03-22) Lin, Pao-Hwa; Grambow, Steven; Intille, Stephen; Gallis, John A; Lazenka, Tony; Bosworth, Hayden; Voils, Corrine L; Bennett, Gary G; Batch, Bryan; Allen, Jenifer; Corsino, Leonor; Tyson, Crystal; Svetkey, LauraBACKGROUNDUnderstanding how engagement in mobile health (mHealth) weight loss interventions relates to weight change may help develop effective intervention strategies.
OBJECTIVEThis study aims to examine the (1) patterns of participant engagement overall and with key intervention components within each intervention arm in the Cell Phone Intervention For You (CITY) trial; (2) associations of engagement with weight change; and (3) participant characteristics related to engagement.
METHODSThe CITY trial tested two 24-month weight loss interventions. One was delivered with a smartphone app (cell phone) containing 24 components (weight tracking, etc) and included prompting by the app in predetermined frequency and forms. The other was delivered by a coach via monthly calls (personal coaching) supplemented with limited app components (18 overall) and without any prompting by the app. Engagement was assessed by calculating the percentage of days each app component was used and the frequency of use. Engagement was also examined across 4 weight change categories: gained (≥2%), stable (±2%), mild loss (≥2% to <5%), and greater loss (≥5%).
RESULTSData from 122 cell phone and 120 personal coaching participants were analyzed. Use of the app was the highest during month 1 for both arms; thereafter, use dropped substantially and continuously until the study end. During the first 6 months, the mean percentage of days that any app component was used was higher for the cell phone arm (74.2%, SD 20.1) than for the personal coaching arm (48.9%, SD 22.4). The cell phone arm used the apps an average of 5.3 times/day (SD 3.1), whereas the personal coaching participants used them 1.7 times/day (SD 1.2). Similarly, the former self-weighed more than the latter (57.1% days, SD 23.7 vs 32.9% days, SD 23.3). Furthermore, the percentage of days any app component was used, number of app uses per day, and percentage of days self-weighed all showed significant differences across the 4 weight categories for both arms. Pearson correlation showed a negative association between weight change and the percentage of days any app component was used (cell phone: r=−.213; personal coaching: r=−.319), number of apps use per day (cell phone: r=−.264; personal coaching: r=−.308), and percentage of days self-weighed (cell phone: r=−.297; personal coaching: r=−.354). None of the characteristics examined, including age, gender, race, education, income, energy expenditure, diet quality, and hypertension status, appeared to be related to engagement.
CONCLUSIONSEngagement in CITY intervention was associated with weight loss during the first 6 months. Nevertheless, engagement dropped substantially early on for most intervention components. Prompting may be helpful initially. More flexible and less intrusive prompting strategies may be needed during different stages of an intervention to increase or sustain engagement. Future studies should explore the motivations for engagement and nonengagement to determine meaningful levels of engagement required for effective intervention.
CLINICALTRIALClinicalTrials.gov NCT01092364; https://clinicaltrials.gov/ct2/show/NCT01092364 (Archived by WebCite at http://www.webcitation.org/72V8A4e5X)
Item Open Access The Association Between Engagement and Weight Loss Through Personal Coaching and Cell Phone Interventions in Young Adults: Randomized Controlled Trial.(JMIR mHealth and uHealth, 2018-10) Lin, Pao-Hwa; Grambow, Steven; Intille, Stephen; Gallis, John A; Lazenka, Tony; Bosworth, Hayden; Voils, Corrine L; Bennett, Gary G; Batch, Bryan; Allen, Jenifer; Corsino, Leonor; Tyson, Crystal; Svetkey, LauraBackground
Understanding how engagement in mobile health (mHealth) weight loss interventions relates to weight change may help develop effective intervention strategies.Objective
This study aims to examine the (1) patterns of participant engagement overall and with key intervention components within each intervention arm in the Cell Phone Intervention For You (CITY) trial; (2) associations of engagement with weight change; and (3) participant characteristics related to engagement.Methods
The CITY trial tested two 24-month weight loss interventions. One was delivered with a smartphone app (cell phone) containing 24 components (weight tracking, etc) and included prompting by the app in predetermined frequency and forms. The other was delivered by a coach via monthly calls (personal coaching) supplemented with limited app components (18 overall) and without any prompting by the app. Engagement was assessed by calculating the percentage of days each app component was used and the frequency of use. Engagement was also examined across 4 weight change categories: gained (≥2%), stable (±2%), mild loss (≥2% to <5%), and greater loss (≥5%).Results
Data from 122 cell phone and 120 personal coaching participants were analyzed. Use of the app was the highest during month 1 for both arms; thereafter, use dropped substantially and continuously until the study end. During the first 6 months, the mean percentage of days that any app component was used was higher for the cell phone arm (74.2%, SD 20.1) than for the personal coaching arm (48.9%, SD 22.4). The cell phone arm used the apps an average of 5.3 times/day (SD 3.1), whereas the personal coaching participants used them 1.7 times/day (SD 1.2). Similarly, the former self-weighed more than the latter (57.1% days, SD 23.7 vs 32.9% days, SD 23.3). Furthermore, the percentage of days any app component was used, number of app uses per day, and percentage of days self-weighed all showed significant differences across the 4 weight categories for both arms. Pearson correlation showed a negative association between weight change and the percentage of days any app component was used (cell phone: r=-.213; personal coaching: r=-.319), number of apps use per day (cell phone: r=-.264; personal coaching: r=-.308), and percentage of days self-weighed (cell phone: r=-.297; personal coaching: r=-.354). None of the characteristics examined, including age, gender, race, education, income, energy expenditure, diet quality, and hypertension status, appeared to be related to engagement.Conclusions
Engagement in CITY intervention was associated with weight loss during the first 6 months. Nevertheless, engagement dropped substantially early on for most intervention components. Prompting may be helpful initially. More flexible and less intrusive prompting strategies may be needed during different stages of an intervention to increase or sustain engagement. Future studies should explore the motivations for engagement and nonengagement to determine meaningful levels of engagement required for effective intervention.Trial registration
ClinicalTrials.gov NCT01092364; https://clinicaltrials.gov/ct2/show/NCT01092364 (Archived by WebCite at http://www.webcitation.org/72V8A4e5X).Item Open Access The Balance protocol: a pragmatic weight gain prevention randomized controlled trial for medically vulnerable patients within primary care.(BMC public health, 2019-05-17) Berger, Miriam B; Steinberg, Dori M; Askew, Sandy; Gallis, John A; Treadway, Cayla C; Egger, Joseph R; Kay, Melissa C; Batch, Bryan C; Finkelstein, Eric A; DeVries, Abigail; Brewer, Ashley; Bennett, Gary GBackground
For patients with obesity who are not ready for or experience barriers to weight loss, clinical practice guidelines recommend provider counseling on preventing further weight gain as a first-line treatment approach. Unfortunately, evidence-based weight gain prevention interventions are not routinely available within primary care. To address this gap, we will implement a pragmatic 12-month randomized controlled trial of a digital weight gain prevention intervention delivered to patients receiving primary care within a network of Federally Qualified Community Health Centers in central North Carolina.Methods
Balance (Equilibrio in Spanish) is a pragmatic effectiveness trial that will randomize adult patients who have overweight or obesity (BMI of 25-40 kg/m2) to either: 1) a weight gain prevention intervention with tailored behavior change goals and tracking, daily weighing on a network-connected electronic scale, and responsive weight and goal coaching delivered remotely by health center registered dietitians; or 2) a usual care program with automated healthy living text messages and print materials and routine primary care. The primary outcome will be weight gain prevention at 24-months, defined as ≤3% change in baseline weight. To align with its pragmatic design, trial outcome data will be pulled from the electronic health record of the community health center network.Discussion
For underserved, often rurally-located patients with obesity, digital approaches to promote a healthy lifestyle can curb further weight gain. Yet enrolling medically vulnerable patients into a weight gain prevention trial, many of whom are from racial/ethnic minorities, can be difficult. Despite these potential challenges, we plan to recruit a large, diverse sample from rural areas, and will implement a remotely-delivered weight gain prevention intervention to medically vulnerable patients. Upcoming trial results will demonstrate the effectiveness of this pragmatic approach to implement and evaluate a digital weight gain prevention intervention within primary care.Trials registration
NCT03003403 . Registered December 28, 2016.Item Open Access The Long-Term Benefits of an Integrated Model to Treat Childhood Obesity(2019-04-15) Pasquale, EllenObjective: To understand short- and long-term outcomes of diverse, low-income participants in a childhood obesity intervention, and to examine participant expectations, motivators, facilitators, and barriers to program attendance and engagement. Methods: A sequential mixed-methods study design was employed: first, a retrospective analysis of an integrated clinic-community intervention cohort to identify predictors of success at the end of a six-month intervention. Then, the most and least successful participants and their parents were recruited to participate in in-depth semi-structured audio-recorded interviews. Transcripts were analyzed with a thematic analysis approach. Themes were grouped into categories including: (1) barriers and (2) facilitators and motivators of program attendance and engagement, (3) program expectations, (4) lifestyle effects, and (5) parent perceptions of effects on child health. Body mass index z-scores (BMIz) two years after intervention completion were obtained to assess long-term effects of the program. Results: Only Hispanic race was found to be a significant predictor of BMIz reduction at intervention completion. Two years after program completion, intervention participants reduced their BMIz by 0.07. Prominent barriers to program engagement included travel to intervention site and parent work schedules. Motivators included social support from family members and enjoyment of program sessions. All participants cited at least one lifestyle change, including improved diet choices and increased physical activity levels. All parents expressed satisfaction with some aspect of the program, even if their child did not lose weight. Conclusion: Results suggest a number of positive long-term outcomes associated with an integrated clinic-community treatment model, which include BMIz reduction, increased health education, positive eating changes, and increased physical activity levels.Item Open Access Track: A randomized controlled trial of a digital health obesity treatment intervention for medically vulnerable primary care patients.(Contemporary clinical trials, 2016-05) Foley, Perry; Steinberg, Dori; Levine, Erica; Askew, Sandy; Batch, Bryan C; Puleo, Elaine M; Svetkey, Laura P; Bosworth, Hayden B; DeVries, Abigail; Miranda, Heather; Bennett, Gary GIntroduction
Obesity continues to disproportionately affect medically vulnerable populations. Digital health interventions may be effective for delivering obesity treatment in low-resource primary care settings.Methods
Track is a 12-month randomized controlled trial of a digital health weight loss intervention in a community health center system. Participants are 351 obese men and women aged 21 to 65years with an obesity-related comorbidity. Track participants are randomized to usual primary care or to a 12-month intervention consisting of algorithm-generated tailored behavior change goals, self-monitoring via mobile technologies, daily self-weighing using a network-connected scale, skills training materials, 18 counseling phone calls with a Track coach, and primary care provider counseling. Participants are followed over 12months, with study visits at baseline, 6, and 12months. Anthropometric data, blood pressure, fasting lipids, glucose and HbA1C and self-administered surveys are collected. Follow-up data will be collected from the medical record at 24months.Results
Participants are 68% female and on average 50.7years old with a mean BMI of 35.9kg/m(2). Participants are mainly black (54%) or white (33%); 12.5% are Hispanic. Participants are mostly employed and low-income. Over 20% of the sample has hypertension, diabetes and hyperlipidemia. Almost 27% of participants currently smoke and almost 20% score above the clinical threshold for depression.Conclusions
Track utilizes an innovative, digital health approach to reduce obesity and chronic disease risk among medically vulnerable adults in the primary care setting. Baseline characteristics reflect a socioeconomically disadvantaged, high-risk patient population in need of evidence-based obesity treatment.Item Open Access Variable-dose support in an online mental health intervention: A randomized, controlled exploratory study(2022) Brooks, JackDigital health interventions are widely considered a highly promising solution to issues with access to evidence-based care. However, digital health interventions are limited by lower rates of engagement than are typically seen in traditional, face-to-face interventions. Despite the importance of engagement for intervention efficacy, engagement is rarely a primary outcome in intervention studies, and few studies have empirically tested intervention changes to improve engagement. Hazel was a two-arm, randomized controlled exploratory study designed to investigate the impact of intervention design on engagement as a primary outcome. We conducted a trial of a mental health intervention, based on the Unified Protocol, delivered entirely online. Participants were randomized to complete the 12-week intervention self-guided (the unsupported arm) or with 4 weeks of therapist support (the supported arm). We sought to measure engagement as comprehensively as possible and therefore collected numerous self-report, behavioral, and objective measures of multiple facets of engagement, including how participants felt about the intervention, how they used the intervention technology, and how their behavior changed over the course of the intervention. We collected engagement outcomes at baseline, weekly during the intervention, and immediately following completion of the intervention. We hypothesized that a low dose of therapist support would improve engagement and subsequent mental health outcomes while being more scalable and feasible to implement than offering therapist support during all intervention weeks. The aims of this small, exploratory study were to learn more about patterns of engagement with the intervention and identify issues with the current intervention and trial design. We used descriptive statistics and visualizations to understand and describe trends in the data rather than p-value significance testing, in line with best practices for pilot studies. We recruited 23 North Carolina-based adults with clinically elevated depression and/or anxiety symptoms. Overall, the intervention and trial design appeared acceptable to participants. Participants in both arms had relatively positive attitudes toward the intervention at all time points, and there was no evidence that the response burden of our outcome measures was too high. However, several of our measures showed little variation between participants or over time. Our findings provides guidance for future studies to select alternative measures and/or to administer some engagement measures less frequently. This represents a meaningful step forward for the field of engagement research, as prior to this study, there was almost no empirical guidance on how to select measures of engagement or how frequently to administer them. We observed a substantial drop in engagement for participants in the supported arm when video sessions began, contrary to our expectations that video sessions would improve engagement. Notably, video sessions began partway through the intervention and participants were blinded to condition until the onset of these sessions; changes to blinding and/or timing of video sessions might improve engagement. At the same time, those participants in the supported arm who did engage in video sessions (n=4) completed more of each weekly lesson than participants in the unsupported arm, indicating that there is evidence that therapist support can increase engagement. Secondary outcomes were sample diversity and depression and anxiety symptom change. Our sample was comparably diverse to other digital health studies in terms of race and socioeconomic status, and we overrecruited LGBTQ+-identified participants. Despite finding little evidence of changes in behavior or the theoretical mechanisms underlying the intervention, the majority of participants showed improvement in their symptoms.
Item Open Access "We bleed for our community:" A qualitative exploration of the implementation of a pragmatic weight gain prevention trial from the perspectives of community health center professionals.(BMC public health, 2023-04) Berger, Miriam B; Chisholm, Miriam; Miller, Hailey N; Askew, Sandy; Kay, Melissa C; Bennett, Gary GBackground
Clinical trial implementation continues to shift toward pragmatic design, with the goal of increasing future adoption in clinical practice. Yet, few pragmatic trials within clinical settings have qualitatively assessed stakeholder input, especially from those most impacted by research implementation and outcomes, i.e., providers and staff. Within this context, we conducted a qualitative study of the implementation of a pragmatic digital health obesity trial with employees at a Federally qualified health center (FQHC) network in central North Carolina.Methods
Participant recruitment was conducted through purposive sampling of FQHC employees from a variety of backgrounds. Two researchers conducted semi-structured qualitative interviews and collected demographic data. Interviews were digitally recorded, professionally transcribed and double-coded by two independent researchers using NVivo 12. Coding discrepancies were reviewed by a third researcher until intercoder consensus was reached. Responses were compared within and across participants to elucidate emergent themes.Results
Eighteen qualitative interviews were conducted, of whom 39% provided direct medical care to patients and 44% worked at the FQHC for at least seven years. Results illuminated the challenges and successes of a pragmatically designed obesity treatment intervention within the community that serves medically vulnerable patients. Although limited time and staffing shortages may have challenged recruitment processes, respondents described early buy-in from leadership; an alignment of organizational and research goals; and consideration of patient needs as facilitators to implementation. Respondents also described the need for personnel power to sustain novel research interventions and considerations of health center resource constraints.Conclusions
Results from this study contribute to the limited literature on pragmatic trials utilizing qualitative methods, particularly in community-based obesity treatment. To continue to merge the gaps between research implementation and clinical care, qualitative assessments that solicit stakeholder input are needed within pragmatic trial design. For maximum impact, researchers may wish to solicit input from a variety of professionals at trial onset and ensure that shared common goals and open collaboration between all partners is maintained throughout the trial.Trial registration
This trial was registered with ClinicalTrials.gov (NCT03003403) on December 28, 2016.Item Open Access Women, Infants, and Children Providers' Perceptions of Managing Obesity in Pregnancy: A Qualitative Study(2017-05-01) Carp, Julia E.Obesity is exceedingly common among low-income pregnant mothers, a primary target population of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). While protocols at WIC address this nutritional problem, WIC nutritionists’ perceptions of the challenges of managing obesity in pregnancy are unknown. A qualitative study was conducted using data transcribed from audiotapes of focus groups among 27 Philadelphia WIC nutritionists to identify barriers and facilitators of counseling pregnant clients with obesity. Transcripts were coded for most common themes. Findings revealed 11 major themes clustered into three categories. The first category focused on barriers to counseling that WIC providers perceived were client driven. They perceived that mothers with obesity 1) were burdened by competing demands in their lives; 2) lacked interest in changing their nutrition behaviors; 3) misperceived their weight and healthfulness of diet; and 4) had difficulty prioritizing WIC input due to conflicting advice from others. The second category addressed barriers WIC providers perceived were WIC driven. They felt that 5) they were constrained by structural barriers at WIC; 6) counseling was protocol driven; and 7) they feared they would offend mothers. The last category described facilitators to creating more effective counseling sessions. Providers’ strategies were to 8) meet mothers where they are; 9) set small behavioral goals; 10) frame messages around baby’s development; and 11) build rapport early to establish trust. WIC nutritionists reported numerous barriers to counseling pregnant clients with obesity. Yet several potential solutions were uncovered, including: training WIC staff to use a patient-centered counseling approach; incorporating technology to overcome issues of time-management and follow-up; developing collaborations with family and other healthcare providers; and message framing around baby to help WIC clients adhere to nutrition goals.