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

BMC Public Health

Eric A. Finkelstein¹  Miriam B. Berger²  Sandy Askew²  Cayla C. Treadway²  Melissa C. Kay²  Dori M. Steinberg³  Gary G. Bennett⁴  John A. Gallis⁵  Joseph R. Egger⁵  Bryan C. Batch⁶  Ashley Brewer⁷  Abigail DeVries⁷ 

[1] 0000 0001 2180 6431, grid.4280.e, National University of Singapore, Tahir Foundation Building, 12 Science Drive 2, #10-01, 117549, Singapore, Singapore;0000 0004 1936 7961, grid.26009.3d, Duke Global Digital Health Science Center, Duke University, Campus Box 90086, 27708-0086, Durham, NC, USA;0000 0004 1936 7961, grid.26009.3d, Duke Global Digital Health Science Center, Duke University, Campus Box 90086, 27708-0086, Durham, NC, USA;0000 0004 1936 7961, grid.26009.3d, Duke University School of Nursing, 307 Trent Drive, Pearson Room 2055, DUMC 3322, 27708, Durham, NC, USA;0000 0004 1936 7961, grid.26009.3d, Duke Global Digital Health Science Center, Duke University, Campus Box 90086, 27708-0086, Durham, NC, USA;0000 0004 1936 7961, grid.26009.3d, Duke University, Department of Psychology and Neuroscience, Campus Box 90086, 27708, Durham, NC, USA;0000 0004 1936 7961, grid.26009.3d, Duke Global Health Institute, Duke University, Trent Drive, Room 236, 27708, Durham, NC, USA;0000000100241216, grid.189509.c, Duke University Medical Center, DUMC 3031, 27710, Durham, NC, USA;Piedmont Health Services, Inc., 127 Kingston Drive, 27514, Chapel Hill, NC, USA;

关键词: Obesity;    Pragmatic;    Digital health;    E-health;    Primary care;    Weight;    Rural health;    Minority health;    Latino health;   

DOI  :  10.1186/s12889-019-6926-7

来源: publisher

【 摘 要 】

BackgroundFor 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.MethodsBalance (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.DiscussionFor 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 registrationNCT03003403. Registered December 28, 2016.

【 授权许可】

CC BY