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

Sponsor

Duke University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03003403

Collaborator

(none)

443

Enrollment

Location

Arms

75.9

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Overweight Overnutrition Nutrition Disorders Signs and Symptoms	Behavioral: Intervention Program	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

443 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Apr 30, 2022

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Intervention Program 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.
No Intervention: Usual Care Program 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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: Intervention Program

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.

No Intervention: Usual Care Program

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.

Outcome Measures

Primary Outcome Measures

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

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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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