An interventional study of Intervention Program in Obesity, Overweight and Overnutrition, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-16.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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 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.
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.
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
Time frame: Baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
Change in Weight
Average change in participant weight at 24 months post randomization, as measured in kg
Time frame: Baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
Change in Blood Pressure
Average change in participant systolic and diastolic blood pressure at 24 months post-randomization, as measured in millimeters of mercury (mm Hg), by arm
Time frame: baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
Change in Framingham Risk Score
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. The Framingham Risk Score provides an estimate of the 10-year risk of developing cardiovascular disease. A decrease (negative) in score indicated a decreased 10-year risk of developing cardiovascular disease; an increase (positive) in score meant an increased 10-year risk of developing cardiovascular disease. Framingham score ranges vary by gender. For men, the minimum score is: -10 and maximum score is 21. For women: the min score is -8 and max score is 27.
Time frame: baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
Patients were recruited from partnering community health centers (CHCs) that worked with the Duke research team. Per privacy regulations, prior to being contacted by a team member, CHC patients were asked to review/sign a HIPAA authorization form to give permission to be contacted for recruitment. Once the form was received, study team members conducted an eligibility review in the CHC EHR. If eligible and interested, additional screening, verbal consent and randomization occurred via phone.
| Milestone | Intervention Program | Usual Care Program |
|---|---|---|
| Started | 223 | 220 |
| Completed | 212 | 212 |
| Not completed | 11 | 8 |
| Withdrew: Ineligible | 8 | 7 |
| Withdrew: Withdrawal by subject | 3 | 1 |
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
| Participants | Intervention Program | Usual Care Program |
|---|---|---|
| Gained more than 3% | 28 | 29 |
| Gained less than or equal to 3% of predicted baseline weight | 88 | 90 |
| Not measured in time window | 107 | 101 |
Average change in participant weight at 24 months post randomization, as measured in kg
| change in weight by kg | Intervention Program | Usual Care Program |
|---|---|---|
| Change in Weight | 0.4 (-0.4 to 1.2) | 0.5 (-0.3 to 1.5) |
Average change in participant systolic and diastolic blood pressure at 24 months post-randomization, as measured in millimeters of mercury (mm Hg), by arm
| millimeters of mercury (mmHg) | Intervention Program | Usual Care Program |
|---|---|---|
| Average change in systolic blood pressure | -1.3 (-3.1 to 0.6) | -0.1 (-2 to 1.9) |
| Average change in diastolic blood pressure | -2.8 (-4 to -1.5) | -2 (-3.3 to -0.7) |
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. The Framingham Risk Score provides an estimate of the 10-year risk of developing cardiovascular disease. A decrease (negative) in score indicated a decreased 10-year risk of developing cardiovascular disease; an increase (positive) in score meant an increased 10-year risk of developing cardiovascular disease. Framingham score ranges vary by gender. For men, the minimum score is: -10 and maximum score is 21. For women: the min score is -8 and max score is 27.
| units on a scale | Intervention Program | Usual Care Program |
|---|---|---|
| Change in Framingham Risk Score | -0.01 (-0.6 to 0.6) | -0.01 (-0.7 to 0.6) |
Collected over Randomization through 12 months (active intervention phase). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Program | 0/223 (0%) | 22/223 (9.9%) | 42/223 (18.8%) |
| Usual Care Program | 0/220 (0%) | 13/220 (5.9%) | 34/220 (15.5%) |
| Event | Intervention Program | Usual Care Program |
|---|---|---|
| Hypertension-related complicationsCardiac disorders | 5/223 | 4/220 |
| Breathing complications (asthma, COVID19, infections)Respiratory, thoracic and mediastinal disorders | 4/223 | 3/220 |
| Severe abdominal pain, discomfort, symptomsGastrointestinal disorders | 3/223 | 2/220 |
| Motor vehicle accident; fallInjury, poisoning and procedural complications | 3/223 | 0/220 |
| Parkinson's related complicationsNervous system disorders | 1/223 | 2/220 |
| Skin infectionsSkin and subcutaneous tissue disorders | 0/223 | 2/220 |
| General infectious diseasesInfections and infestations | 2/223 | 0/220 |
| Surgical procedures for heart/GISurgical and medical procedures | 1/223 | 1/220 |
| Kidney and urinary tract infectionRenal and urinary disorders | 1/223 | 1/220 |
| Bone fractureMusculoskeletal and connective tissue disorders | 1/223 | 0/220 |
| Event | Intervention Program | Usual Care Program |
|---|---|---|
| Minor fallsInjury, poisoning and procedural complications | 11/223 | 4/220 |
| Minor stomach painGastrointestinal disorders | 4/223 | 7/220 |
| Hypertension-related issuesCardiac disorders | 5/223 | 5/220 |
| Shortness of breath, minor respiratory infectionsRespiratory, thoracic and mediastinal disorders | 4/223 | 5/220 |
| Sprains/strainsMusculoskeletal and connective tissue disorders | 4/223 | 4/220 |
| Minor UTIsRenal and urinary disorders | 4/223 | 1/220 |
| Neoplasms/cystsNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/223 | 3/220 |
| Eye infectionsEye disorders | 3/223 | 1/220 |
| Minor outpatient surgical proceduresSurgical and medical procedures | 3/223 | 0/220 |
| Misc non-systemic infectionsInfections and infestations | 2/223 | 0/220 |
Final randomized sample was 443 participants
| Age, Continuous(years) | Intervention Program | Usual Care Program | Total |
|---|---|---|---|
| Mean | 48.5 ± 13.6 | 46.8 ± 13.0 | 47.6 ± 13.3 |
| Sex/Gender, Customized(Participants) | Intervention Program | Usual Care Program | Total |
|---|---|---|---|
| Male | 43 | 46 | 89 |
| Female | 179 | 173 | 352 |
| Male to Female Transgender | 1 | 1 | 2 |
| Race/Ethnicity, Customized(Participants) | Intervention Program | Usual Care Program | Total |
|---|---|---|---|
| Hispanic (all races) | 102 | 98 | 200 |
| Non-Hispanic White | 61 | 54 | 115 |
| Non-Hispanic Black | 53 | 53 | 106 |
| Non-Hispanic other/unreported | 7 | 15 | 22 |
| BMI(kg/m2) | Intervention Program | Usual Care Program | Total |
|---|---|---|---|
| Mean | 32.4 ± 4.0 | 32.9 ± 3.9 | 32.6 ± 4.0 |
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Duke University