Nutrition Disorders, Obesity, Overnutrition, Overweight, Signs and Symptoms
Conditions
Keywords
mHealth, Digital Health, Primary Care, Pragmatic Clinical Trial, Behavior Change, Weight Management
Brief 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. 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.
Interventions
BEHAVIORALIntervention 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.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight at 24-months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight | 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 |
| Change in Blood Pressure | 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), by arm |
| Change in Framingham Risk Score | 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. 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
443 participants were randomized after being eligible upon EHR chart review; phone screen and verbal consent and randomization.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 223 |
| 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. | 220 |
| Total | 443 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Ineligible | 8 | 7 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Intervention Program | Usual Care Program | Total |
|---|---|---|---|
| Age, Continuous | 48.5 years STANDARD_DEVIATION 13.6 | 46.8 years STANDARD_DEVIATION 13 | 47.6 years STANDARD_DEVIATION 13.3 |
| BMI | 32.4 kg/m2 STANDARD_DEVIATION 4 | 32.9 kg/m2 STANDARD_DEVIATION 3.9 | 32.6 kg/m2 STANDARD_DEVIATION 4 |
| Race/Ethnicity, Customized Hispanic (all races) | 102 Participants | 98 Participants | 200 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 53 Participants | 53 Participants | 106 Participants |
| Race/Ethnicity, Customized Non-Hispanic other/unreported | 7 Participants | 15 Participants | 22 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 61 Participants | 54 Participants | 115 Participants |
| Sex/Gender, Customized Female | 179 Participants | 173 Participants | 352 Participants |
| Sex/Gender, Customized Male | 43 Participants | 46 Participants | 89 Participants |
| Sex/Gender, Customized Male to Female Transgender | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 223 | 0 / 220 |
| other Total, other adverse events | 42 / 223 | 34 / 220 |
| serious Total, serious adverse events | 22 / 223 | 13 / 220 |
Outcome results
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
Time frame: Baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
Population: Entire sample analyzed for primary endpoint at 24-months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Program | Change in Weight at 24-months | Gained more than 3% | 28 Participants |
| Intervention Program | Change in Weight at 24-months | Gained less than or equal to 3% of predicted baseline weight | 88 Participants |
| Intervention Program | Change in Weight at 24-months | Not measured in time window | 107 Participants |
| Usual Care Program | Change in Weight at 24-months | Gained more than 3% | 29 Participants |
| Usual Care Program | Change in Weight at 24-months | Gained less than or equal to 3% of predicted baseline weight | 90 Participants |
| Usual Care Program | Change in Weight at 24-months | Not measured in time window | 101 Participants |
p-value: 0.9795% CI: [0.82, 1.2]bootstrap resampling
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
Time frame: baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
Population: Predicted mean change (in mmHg) in systolic blood pressure and diastolic blood pressure, from baseline to 24 months, by study arm
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention Program | Change in Blood Pressure | Average change in systolic blood pressure | -1.3 millimeters of mercury (mmHg) |
| Intervention Program | Change in Blood Pressure | Average change in diastolic blood pressure | -2.8 millimeters of mercury (mmHg) |
| Usual Care Program | Change in Blood Pressure | Average change in systolic blood pressure | -0.1 millimeters of mercury (mmHg) |
| Usual Care Program | Change in Blood Pressure | Average change in diastolic blood pressure | -2 millimeters of mercury (mmHg) |
p-value: 0.3495% CI: [-3.6, 1.3]Mixed Models Analysis
p-value: 0.32395% CI: [-2.4, 0.8]Mixed Models Analysis
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.
Time frame: baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
Population: Calculated mean change in 10-year cardiovascular risk between baseline and 24-months post-randomization by treatment arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Program | Change in Framingham Risk Score | -0.01 units on a scale |
| Usual Care Program | Change in Framingham Risk Score | -0.01 units on a scale |
p-value: 0.99195% CI: [-0.8, 0.8]Mixed Models Analysis
Secondary
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)
Population: Average weight change (kg) at 24 months.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Program | Change in Weight | 0.4 change in weight by kg |
| Usual Care Program | Change in Weight | 0.5 change in weight by kg |
p-value: 0.8395% CI: [-1.24, 1]Mixed Models Analysis