CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 443 enrolled
Drug / intervention
Intervention Programbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03003403
NCT03003403N/ACompleted

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

Duke University·interventional·Posted Dec 28, 2016·Updated Apr 16, 2025

In Brief

A clinical study evaluating Intervention Program for Obesity and 4 related conditions. Completed, enrolled 443 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedDec 28, 2016
Enrollment StartJan 1, 2017
Primary CompletionApr 30, 2022
Study CompletionApr 30, 2023
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 9.5 years ago

Interventions

Intervention Programbehavioral

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.