Clinical trial NCT03003403: Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care
Official title: Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Overnutrition
Nutrition Disorders
Signs and Symptoms
Keywords: mHealth
Digital Health
Primary Care
Pragmatic Clinical Trial
Behavior Change
Weight Management
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-12-28
Enrollment: 443
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in Weight at 24-months
timeFrame: Baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
Secondary outcomes:
measure: Change in Weight
timeFrame: Baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
measure: Change in Blood Pressure
timeFrame: baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
measure: Change in Framingham Risk Score
timeFrame: baseline, 24 months post-randomization (up to 27 months to obtain 24 month data)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University - with Piedmont Health Services, Inc.
state: North Carolina
Study officials:
affiliation: Duke University
name: Gary G Bennett, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Dori M Steinberg, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.