Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care (D0479)

Duke University

Status: Completed

Conditions: Signs and Symptoms; Nutrition Disorders; Overweight; Overnutrition; Obesity

Treatments: Behavioral: Intervention Program

Study type: Interventional

Funder types: Other

Identifiers

NCT03003403

2017-0738

Details and patient eligibility

About

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.

Full 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.

Enrollment: 443 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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443 participants in 2 patient groups

Intervention Program

Experimental group

Description:

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.

Treatment:

Behavioral: Intervention Program

Usual Care Program

No Intervention group

Description:

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.