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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
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Overnutrition Nutrition Disorders Signs and Symptoms Behavioral: Intervention Program Not Applicable

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.

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Study Type : Interventional
Actual Enrollment : 443 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

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.
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, North Carolina
Duke University - with Piedmont Health Services, Inc.
Durham, North Carolina, United States, 27708
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Gary G Bennett, PhD Duke University
Principal Investigator: Dori M Steinberg, PhD, RD Duke University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03003403     History of Changes
Other Study ID Numbers: D0479
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Duke University:
mHealth
Digital Health
Primary Care
Pragmatic Clinical Trial
Behavior Change
Weight Management

Additional relevant MeSH terms:
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Overweight
Weight Gain
Signs and Symptoms
Nutrition Disorders
Overnutrition
Body Weight
Body Weight Changes