N/A
N=443
Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care
Obesity · Overweight · Overnutrition · Nutrition Disorders · Signs and Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT03003403 ↗Enrolled (actual)
443
Serious AEs
7.9%
Results posted
Apr 2025
Primary outcome: Primary: Change in Weight at 24-months — 28; 29; 88; 90 Participants — p=0.97
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intervention Program (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Weight at 24-months |
28; 29; 88; 90; 107; 101 | 0.97 |
| SECONDARY Change in Weight |
0.4; 0.5 | 0.83 |
| SECONDARY Change in Blood Pressure |
-1.3; -0.1; -2.8; -2 | 0.34 |
| SECONDARY Change in Framingham Risk Score |
-0.01; -0.01 | 0.991 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03003403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.