- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03003403
Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care
May 8, 2023 updated by: Duke University
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 Overview
Status
Completed
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
443
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Durham, North Carolina, United States, 27708
- Duke University - with Piedmont Health Services, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Program
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.
|
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.
|
No Intervention: Usual Care 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in weight
Time Frame: baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in blood pressure
Time Frame: baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
|
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)
|
Change in Framingham risk score
Time Frame: baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
|
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)
|
Intervention cost-effectiveness
Time Frame: 24 months post-randomization (up to 27 months to obtain 24 month data)
|
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.
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24 months post-randomization (up to 27 months to obtain 24 month data)
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Change in weight
Time Frame: Baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gary G Bennett, PhD, Duke University
- Principal Investigator: Dori M Steinberg, PhD, RD, Duke University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
April 30, 2022
Study Completion (Actual)
April 30, 2023
Study Registration Dates
First Submitted
December 16, 2016
First Submitted That Met QC Criteria
December 22, 2016
First Posted (Estimate)
December 28, 2016
Study Record Updates
Last Update Posted (Actual)
May 10, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D0479
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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