Browsing by Author "DeVries, Abigail"

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    ItemOpen 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 G

    Background

    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.
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    ItemOpen 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 G

    Introduction

    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.