The Balance protocol: a pragmatic weight gain prevention randomized controlled trial for medically vulnerable patients within primary care.

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Berger, Miriam B

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Steinberg, Dori M

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Askew, Sandy

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Gallis, John A

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Treadway, Cayla C

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Egger, Joseph R

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Kay, Melissa C

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Batch, Bryan C

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Finkelstein, Eric A

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DeVries, Abigail

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Brewer, Ashley

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Bennett, Gary G

dc.date.accessioned

2022-08-16T10:39:45Z

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2022-08-16T10:39:45Z

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2019-05-17

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2022-08-16T10:39:43Z

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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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10.1186/s12889-019-6926-7

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1471-2458

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1471-2458

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https://hdl.handle.net/10161/25595

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eng

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Springer Science and Business Media LLC

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BMC public health

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10.1186/s12889-019-6926-7

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Humans

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Obesity

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Weight Gain

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Weight Loss

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Treatment Outcome

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Counseling

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Adult

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Vulnerable Populations

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Rural Population

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Community Health Centers

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Primary Health Care

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North Carolina

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Female

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Male

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Overweight

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Randomized Controlled Trials as Topic

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Text Messaging

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Weight Reduction Programs

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Mentoring

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Hispanic or Latino

dc.title

The Balance protocol: a pragmatic weight gain prevention randomized controlled trial for medically vulnerable patients within primary care.

dc.type

Journal article

duke.contributor.orcid

Gallis, John A|0000-0003-1921-8424

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Kay, Melissa C|0000-0002-9695-3126

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Batch, Bryan C|0000-0002-7138-2064

pubs.begin-page

596

pubs.issue

1

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Duke

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School of Medicine

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School of Nursing

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Trinity College of Arts & Sciences

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Staff

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Nursing

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Basic Science Departments

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Clinical Science Departments

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Institutes and Centers

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Biostatistics & Bioinformatics

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Medicine

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Pediatrics

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Medicine, Endocrinology, Metabolism, and Nutrition

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Medicine, Nephrology

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Duke Cancer Institute

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Psychology & Neuroscience

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Institutes and Provost's Academic Units

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University Institutes and Centers

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Duke Global Health Institute

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Initiatives

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Duke Science & Society

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Duke - Margolis Center for Health Policy

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Pediatrics, General Pediatrics and Adolescent Health

pubs.publication-status

Published

pubs.volume

19

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