Obesity Clinical Trial
Official title:
Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care
NCT number | NCT03003403 |
Other study ID # | D0479 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | April 30, 2023 |
Verified date | May 2023 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 443 |
Est. completion date | April 30, 2023 |
Est. primary completion date | April 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke University - with Piedmont Health Services, Inc. | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in weight | 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 | baseline, 24 months post-randomization (up to 27 months to obtain 24 month data) | |
Secondary | Change in weight | Average change in participant weight at 24 months post randomization, as measured in kg | Baseline, 24 months post-randomization (up to 27 months to obtain 24 month data) | |
Secondary | 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) | baseline, 24 months post-randomization (up to 27 months to obtain 24 month data) | |
Secondary | 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 | baseline, 24 months post-randomization (up to 27 months to obtain 24 month data) | |
Secondary | Intervention cost-effectiveness | 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. | 24 months post-randomization (up to 27 months to obtain 24 month data) |
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