Up to 50% of obese patients are not interested in, or ready for, weight loss. Clinical practice guidelines clearly recommend that these patients avoid gaining weight. However, despite this clinical guideline, weight gain prevention interventions are not available in primary care practice. Balance is a pragmatic, randomized controlled effectiveness trial for weight gain prevention for patients within rural community health centers, using a digital health platform.
Clinical practice guidelines emphasize recommend weight gain prevention, but evidence-based treatments are not available in primary care. Balance, a pragmatic effectiveness trial, will test a scalable treatment approach for medically-vulnerable adults, those who suffer disproportionately from obesity and its adverse health effects. Balance builds on the design and findings of the Shape study (NCT00938535) to test a pragmatic intervention within rural community health centers. Balance will randomize overweight adults and adults with obesity who are patients a local community health center network (Piedmont Health Services) to either: 1) a 12-month weight gain prevention intervention or 2) usual care. Intervention group components include tailored behavior change goals; mHealth self-monitoring and feedback; skills training videos; and stepped responsive coaching from clinic Registered Dietitians. The usual care group will receive standard primary care offered by their providers and automated text messages and health information about maintaining a healthy weight. All intervention components and materials will be provided in Spanish or English.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
443
Balance is testing a pragmatic approach to promote weight maintenance among overweight patients and patients with obesity within local community health centers who experience barriers to losing weight. The intervention utilizes the interactive obesity treatment approach, which creates an energy deficit by having participants achieve simple, straightforward, and concrete behavior change goals (e.g., no fast food, no sugary drinks, walk 10,000 steps per day). The Balance intervention involves tailored behavior change goals; self-monitoring using connected scales and mobile technologies; responsive coaching, and tailored feedback and skills training.
Duke University - with Piedmont Health Services, Inc.
Durham, North Carolina, United States
Change in Weight at 24-months
The proportion of intervention arm participants who achieve weight again prevention (staying within 3% of baseline weight in kg) at 24 months post-randomization. This will be calculated as follows: ((baseline weight in kg - final weight at 24 months in kg)/baseline weight in kg))x 100
Time frame: Baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
Change in Weight
Average change in participant weight at 24 months post randomization, as measured in kg
Time frame: Baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
Change in Blood Pressure
Average change in participant systolic and diastolic blood pressure at 24 months post-randomization, as measured in millimeters of mercury (mm Hg), by arm
Time frame: baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
Change in Framingham Risk Score
Average change in participant Framingham risk score at 24 months post-randomization, as measured by calculated 10-year Framingham risk score from the Framingham Heart Study. The Framingham Risk Score provides an estimate of the 10-year risk of developing cardiovascular disease. A decrease (negative) in score indicated a decreased 10-year risk of developing cardiovascular disease; an increase (positive) in score meant an increased 10-year risk of developing cardiovascular disease. Framingham score ranges vary by gender. For men, the minimum score is: -10 and maximum score is 21. For women: the min score is -8 and max score is 27.
Time frame: baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
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