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

NCT03003403 | Completed Results DMC

• 1 other identifier: 2017-0738
• Study Type: interventional
• Target: 443
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

mHealth; Digital Health; Primary Care; Pragmatic Clinical Trial; Behavior Change; Weight Management

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)

Secondary Outcomes (3)

• Change in Weight

  Baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)

• Change in Blood Pressure

  baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)

• Change in Framingham Risk Score

  baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)

Study Arms (2)

Intervention Program

EXPERIMENTAL

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

Usual Care Program

NO INTERVENTION

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.

Interventions

Intervention Program BEHAVIORAL

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.

Intervention Program

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University - with Piedmont Health Services, Inc.

Durham, North Carolina, 27708, United States

Location

Related Publications (3)

• Miller HN, Gallis JA, Berger MB, Askew S, Egger JR, Kay MC, Finkelstein EA, de Leon M, DeVries A, Brewer A, Holder MG, Bennett GG. Weight Gain Prevention Outcomes From a Pragmatic Digital Health Intervention With Community Health Center Patients: Randomized Controlled Trial. J Med Internet Res. 2024 Mar 28;26:e50330. doi: 10.2196/50330. Erratum In: J Med Internet Res. 2024 May 13;26:e60137. doi: 10.2196/60137.

  PMID: 38416574 DERIVED

• Berger MB, Chisholm M, Miller HN, Askew S, Kay MC, Bennett GG. "We bleed for our community:" A qualitative exploration of the implementation of a pragmatic weight gain prevention trial from the perspectives of community health center professionals. BMC Public Health. 2023 Apr 14;23(1):695. doi: 10.1186/s12889-023-15574-2.

  PMID: 37060053 DERIVED

• Berger MB, Steinberg DM, Askew S, Gallis JA, Treadway CC, Egger JR, Kay MC, Batch BC, Finkelstein EA, DeVries A, Brewer A, Bennett GG. The Balance protocol: a pragmatic weight gain prevention randomized controlled trial for medically vulnerable patients within primary care. BMC Public Health. 2019 May 17;19(1):596. doi: 10.1186/s12889-019-6926-7.

  PMID: 31101037 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Body Weight; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Gary G. Bennett, PhD
• Organization: Duke University

gary.bennett@duke.edu

919-808-7821

Study Officials

• Gary G Bennett, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Dori M Steinberg, PhD, RD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 28, 2016
• Study Start: January 1, 2017
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2023
• Last Updated: April 16, 2025
• Results First Posted: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)