Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care
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|ClinicalTrials.gov Identifier: NCT03003403|
Recruitment Status : Active, not recruiting
First Posted : December 28, 2016
Last Update Posted : May 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity Overweight Overnutrition Nutrition Disorders Signs and Symptoms||Behavioral: Intervention Program||Not Applicable|
|Study Type :||Interventional|
|Actual Enrollment :||443 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
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.
Behavioral: 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.
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.
- 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
- 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)
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003403
|United States, North Carolina|
|Duke University - with Piedmont Health Services, Inc.|
|Durham, North Carolina, United States, 27708|
|Principal Investigator:||Gary G Bennett, PhD||Duke University|
|Principal Investigator:||Dori M Steinberg, PhD, RD||Duke University|