Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care
- Conditions
- ObesityNutrition DisordersOverweightSigns and SymptomsOvernutrition
- Interventions
- Behavioral: Intervention Program
- Registration Number
- NCT03003403
- Lead Sponsor
- Duke University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 443
- Patients of Piedmont Health Services' community health centers in central North Carolina only
- BMI between 25 and 40 kg/m2 and weighs less than 380 lbs
- Speaks English or Spanish
- Had a non-urgent outpatient visit at a participating community health center clinic at Piedmont Health Services within the last 2 weeks
- Has a cell phone
- Willing to receive 3-12 study-related text messages per week
- Current Piedmont Health Services employee
- Has past bariatric surgery or planned bariatric surgery (within next 2 years)
- Diagnosed with cancer in the last 6 months and is in active treatment
- Has a history of cardiovascular event (stroke/MI) in the last 12 months
- Was hospitalized for a mental health issue in the last 12 months
- Diagnosis of end stage renal disease
- Currently participating in a weight loss program/research study
- Plans to move out of area and not receive care within community health center network (within the next 2 years)
- Currently or recently pregnant (within the last 6 months) - Females only
- Currently or recently lactating (with the last 2 months)- Females only
- Plans to get pregnant in the next 12 months - Females only
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Program Intervention Program Balance Intervention Program: Participants randomly assigned to the 12-month digital health behavioral intervention will receive: tailored behavior change goals with interactive self-monitoring and feedback; network-connected scales to track their weight; skills training materials; and stepped coaching (via phone and/or text) from Registered Dieticians serving as health coaches within a local network of community health centers.
- Primary Outcome Measures
Name Time Method Change in weight baseline, 24 months post-randomization (up to 27 months to obtain 24 month data) The proportion of intervention arm participants who achieve weight maintenance (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
- Secondary Outcome Measures
Name Time Method Intervention cost-effectiveness 24 months post-randomization (up to 27 months to obtain 24 month data) Assess the intervention's incremental cost at 24 months post-randomization, defined as the cost-effectiveness ratio of cost in dollars per kg of weight maintained at 24 mos, as compared to baseline weight in kg.
Change in weight Baseline, 24 months post-randomization (up to 27 months to obtain 24 month data) Average change in participant weight at 24 months post randomization, as measured in kg
Change in blood pressure baseline, 24 months post-randomization (up to 27 months to obtain 24 month data) Average change in participant systolic and diastolic blood pressure at 24 months post-randomization, as measured in millimeters of mercury (mm Hg)
Change in Framingham risk score baseline, 24 months post-randomization (up to 27 months to obtain 24 month data) 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
Trial Locations
- Locations (1)
Duke University - with Piedmont Health Services, Inc.
🇺🇸Durham, North Carolina, United States