ObesityD0479NCT03003403
Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care
A study testing Intervention Program in people with Obesity and Overweight, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Overnutrition
- What is being tested?
- Intervention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 443 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University - with Piedmont Health Services, Inc.
Durham, North Carolina, 27708
About this study
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.
Read the 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.
- Conditions
- Obesity, Overweight, Overnutrition, Nutrition Disorders, Signs and Symptoms
- Being tested
- Intervention Program
- Keywords
- mHealth, Digital Health, Primary Care, Pragmatic Clinical Trial, Behavior Change, Weight Management
- Medical subject headings
- Obesity, Overweight, Overnutrition, Nutrition Disorders, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Program | Experimental | 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. Receives: Behavioral: Intervention Program |
| Usual Care Program | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
Secondary outcomes (3)
Change in Weight
Average change in participant weight at 24 months post randomization, as measured in kg
Measured: 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
Measured: 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.
Measured: baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startJan 2017
- Primary completion30 Apr 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary G Bennett, PhD, Principal investigator, Duke UniversityDori M Steinberg, PhD, RD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003403
- Sponsor's protocol ID
- 2017-0738
- Acronym
- D0479
- Status last verified
- Apr 2025
- First submitted
- 16 Dec 2016
- Last updated
- 16 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Miller HN, Gallis JA, Askew S, Lee A, Berger MB, Kay MC, Egger JR, Bennett GG. Assessing Electronic Health Record-Derived Outcomes in a Pragmatic Weight Gain Prevention Trial: Effects, Variability, and Implications for Future Trials. J Cardiovasc Nurs. 2026 Mar-Apr 01;41(2):E57-E62. doi: 10.1097/JCN.0000000000001281. Epub 2026 Jan 28.
PubMed 41603635Miller HN, Gallis JA, Berger MB, Askew S, Egger JR, Kay MC, Finkelstein EA, de Leon M, DeVries A, Brewer A, Holder MG, Bennett GG. Weight Gain Prevention Outcomes From a Pragmatic Digital Health Intervention With Community Health Center Patients: Randomized Controlled Trial. J Med Internet Res. 2024 Mar 28;26:e50330. doi: 10.2196/50330.
PubMed 38416574Berger MB, Chisholm M, Miller HN, Askew S, Kay MC, Bennett GG. "We bleed for our community:" A qualitative exploration of the implementation of a pragmatic weight gain prevention trial from the perspectives of community health center professionals. BMC Public Health. 2023 Apr 14;23(1):695. doi: 10.1186/s12889-023-15574-2.
PubMed 37060053Berger MB, Steinberg DM, Askew S, Gallis JA, Treadway CC, Egger JR, Kay MC, Batch BC, Finkelstein EA, DeVries A, Brewer A, Bennett GG. The Balance protocol: a pragmatic weight gain prevention randomized controlled trial for medically vulnerable patients within primary care. BMC Public Health. 2019 May 17;19(1):596. doi: 10.1186/s12889-019-6926-7.
PubMed 31101037
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care
- ClinicalTrials.gov ID
- NCT03003403
- Acronym / sponsor ID
- D0479 / 2017-0738
- Conditions
- Obesity, Overweight, Overnutrition, Nutrition Disorders, Signs and Symptoms
- Keywords
- mHealth, Digital Health, Primary Care, Pragmatic Clinical Trial, Behavior Change, Weight Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 28 Dec 2016 (estimated)
- Results
- Posted 16 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Program | Experimental | Behavioral: Intervention ProgramBalance 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. |
| Usual Care Program | No intervention | –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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention ProgramBalance 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. | Behavioural | Intervention Program |
Primary outcome
Change in Weight at 24-months
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 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
3 secondary outcomes
Change in Weight
Time frame: Baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
Change in Blood Pressure
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41603635Miller HN, Gallis JA, Askew S, Lee A, Berger MB, Kay MC, Egger JR, Bennett GG. Assessing Electronic Health Record-Derived Outcomes in a Pragmatic Weight Gain Prevention Trial: Effects, Variability, and Implications for Future Trials. J Cardiovasc Nurs. 2026 Mar-Apr 01;41(2):E57-E62. doi: 10.1097/JCN.0000000000001281. Epub 2026 Jan 28.
- Derived from this study: PubMed 38416574Miller HN, Gallis JA, Berger MB, Askew S, Egger JR, Kay MC, Finkelstein EA, de Leon M, DeVries A, Brewer A, Holder MG, Bennett GG. Weight Gain Prevention Outcomes From a Pragmatic Digital Health Intervention With Community Health Center Patients: Randomized Controlled Trial. J Med Internet Res. 2024 Mar 28;26:e50330. doi: 10.2196/50330.
- Derived from this study: PubMed 37060053Berger MB, Chisholm M, Miller HN, Askew S, Kay MC, Bennett GG. "We bleed for our community:" A qualitative exploration of the implementation of a pragmatic weight gain prevention trial from the perspectives of community health center professionals. BMC Public Health. 2023 Apr 14;23(1):695. doi: 10.1186/s12889-023-15574-2.
- Derived from this study: PubMed 31101037Berger MB, Steinberg DM, Askew S, Gallis JA, Treadway CC, Egger JR, Kay MC, Batch BC, Finkelstein EA, DeVries A, Brewer A, Bennett GG. The Balance protocol: a pragmatic weight gain prevention randomized controlled trial for medically vulnerable patients within primary care. BMC Public Health. 2019 May 17;19(1):596. doi: 10.1186/s12889-019-6926-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary G Bennett, PhD principal investigator
Duke University
Dori M Steinberg, PhD, RD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Program in people with Obesity and Overweight, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight at 24-months (time frame: Baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03003403, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.