Balance: A Pragmatic Trial of a Digital Health Intervention to Prevent Weight Gain in Primary Care
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Food Studies, Obesity Weight Loss, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology, Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 12/21/2018 |
| Start Date: | January 2017 |
| End Date: | December 2020 |
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.
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.
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.
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
- 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
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