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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 24 months post-randomization (up to 27 months to obtain 24 month data) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Change in Blood Pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary G Bennett, PhD | Duke University | Principal Investigator |
| Dori M Steinberg, PhD, RD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University - with Piedmont Health Services, Inc. | Durham | North Carolina | 27708 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41603635 | Derived | 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. | |
| 38416574 |
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443 participants were randomized after being eligible upon EHR chart review; phone screen and verbal consent and randomization.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Dietitians serving as health coaches within a local network of community health centers. Intervention Program: 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Final randomized sample was 443 participants
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Dietitians serving as health coaches within a local network of community health centers. Intervention Program: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Entire sample analyzed for primary endpoint at 24-months | Posted | Count of Participants | Participants | Baseline, 24 months post-randomization (up to 27 months to obtain 24 month data) |
|
Randomization through 12 months (active intervention phase)
We used the clinicaltrials.gov definitions for adverse events. Adverse events were collected directly from participants (email, phone, and/or text) and via medical chart reviews at 6- and 12-months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Dietitians serving as health coaches within a local network of community health centers. Intervention Program: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe abdominal pain, discomfort, symptoms | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension-related issues | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary G. Bennett, PhD | Duke University | 919-808-7821 | gary.bennett@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 21, 2024 | Mar 18, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D012816 | Signs and Symptoms |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
Average change in participant systolic and diastolic blood pressure at 24 months post-randomization, as measured in millimeters of mercury (mm Hg), by arm
| 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. | baseline, 24 months post-randomization (up to 27 months to obtain 24 month data) |
| Miller 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. |
| 37060053 | Derived | Berger 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. |
| 31101037 | Derived | Berger 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| OG001 | 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. |
|
|
|
| Secondary | Change in Weight | Average change in participant weight at 24 months post randomization, as measured in kg | Average weight change (kg) at 24 months. | Posted | Mean | 95% Confidence Interval | change in weight by 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), by arm | Predicted mean change (in mmHg) in systolic blood pressure and diastolic blood pressure, from baseline to 24 months, by study arm | Posted | Mean | 95% Confidence Interval | millimeters of mercury (mmHg) | 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. 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. | Calculated mean change in 10-year cardiovascular risk between baseline and 24-months post-randomization by treatment arm. | Posted | Mean | 95% Confidence Interval | units on a scale | baseline, 24 months post-randomization (up to 27 months to obtain 24 month data) |
|
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|
|
| 0 |
| 223 |
| 22 |
| 223 |
| 42 |
| 223 |
| EG001 | 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. | 0 | 220 | 13 | 220 | 34 | 220 |
| Motor vehicle accident; fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Bone fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cysts/Polyps requiring cancer treatment/other intervention | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Parkinson's related complications | Nervous system disorders | Systematic Assessment |
|
| Breathing complications (asthma, COVID19, infections) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Surgical procedures for heart/GI | Surgical and medical procedures | Systematic Assessment |
|
| Psychosis | Psychiatric disorders | Systematic Assessment |
|
| Diabetes related complications | Endocrine disorders | Systematic Assessment |
|
| Kidney and urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
| Hypertension-related complications | Cardiac disorders | Systematic Assessment |
|
| Skin infections | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| General infectious diseases | Infections and infestations | Systematic Assessment |
|
| Minor falls | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Eye infections | Eye disorders | Systematic Assessment |
|
| Minor UTIs | Renal and urinary disorders | Systematic Assessment |
|
| Minor stomach pain | Gastrointestinal disorders | Systematic Assessment |
|
| Sprains/strains | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Minor nerve pain/issues | Nervous system disorders | Systematic Assessment |
|
| Neoplasms/cysts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Psychiatric condition (due to lack of medication) | Psychiatric disorders | Systematic Assessment |
|
| Shortness of breath, minor respiratory infections | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Uterine fibroid | Reproductive system and breast disorders | Systematic Assessment |
|
| Diabetes-related complications | Endocrine disorders | Systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Minor outpatient surgical procedures | Surgical and medical procedures | Systematic Assessment |
|
| Ear infection | Ear and labyrinth disorders | Systematic Assessment |
|
| Misc non-systemic infections | Infections and infestations | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| 0.323 |
| Mean Difference (Final Values) |
| -0.8 |
| 2-Sided |
| 95 |
| -2.4 |
| 0.8 |
| Superiority |
Difference in diastolic blood pressure change post-baseline comparing intervention to usual care arm at 24 months. |