Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care

Conditions
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Obesity, Overweight, Overnutrition, Nutrition Disorders, Signs and Symptoms

Intervention / Treatment
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* Behavioral: Intervention Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Program<br>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. | Behavioral: Intervention Program<br>* 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.<br>|
| No Intervention: Usual Care Program<br>Balance Usual Care Program: Participants randomly assigned to the Usual Care program will receive the standard primary care offered by their providers; health information/skills training materials to maintain a healthy weight; and automated (non-tailored) text messages with health information. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight | 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 | baseline, 24 months post-randomization (up to 27 months to obtain 24 month data) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight | Average change in participant weight at 24 months post randomization, as measured in kg | 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) | 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 | baseline, 24 months post-randomization (up to 27 months to obtain 24 month data) | 
| Intervention cost-effectiveness | 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. | 24 months post-randomization (up to 27 months to obtain 24 month data) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, Digital Health, Primary Care, Pragmatic Clinical Trial, Behavior Change, Weight Management