Implementing the Make Better Choices 2 mHealth Energy Balance Intervention for Rural Appalachians
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 279
- Locations
- 2
- Primary Endpoint
- Change in diet and activity
Study Overview
Brief Summary
The program consists of four interconnected components: (1) app, (2) accelerometer, (3) health coaching, and (4) behavioral incentives to increase food and vegetable intake, reduce saturated fat intake, increase physical activity, and decrease sedentary screen time among adults Appalachia Kentuckians.
Detailed Description
Rural Appalachians suffer among the worst health profiles in the US including elevated rates of cardiovascular disease. Although a healthy diet and active lifestyle can reduce mortality and morbidity, only 12% of rural Appalachian Kentuckians consume the recommended daily intake for fruits and vegetables and nearly 35% indicate no physical activity. Personal technology is increasingly common in rural Appalachia, presenting a new opportunity to prevent and manage chronic disease. Most (68%) Appalachian Kentuckians have smart phones and reliable internet access (78%). We propose the first (to our knowledge) adapted evidence-based, multicomponent mHealth (mobile health) intervention program among rural Appalachians. The Make Better Choices 2 (MBC2) intervention has produced significant and sustained improvements in diet and physical activity, using personalized health coaching, an app, accelerometer, and financial incentives. Because of sparse local resources, rural Appalachian residents could greatly benefit from access to appropriate virtual resources through health coaching and mHealth.
In this study, 350 participants will be randomized to receive either the adapted MBC2 or a stress management program. The primary outcome, diet and activity improvement, is a composite change score relative to baseline scores for fruit and vegetable (F/V) intake, fat, physical activity, and sedentary leisure screen time.
Adapted MBC2 intervention content:
The program consists of four interconnected components: (1) app, (2) accelerometer, (3) health coaching, and (4) behavioral incentives. These components encompass behavioral and implementation principles-effectiveness, scalability, and synergy and correspond to the Goal Systems Theory, enhanced by sociocultural and environmental considerations.
- App: As demonstrated in recent research, increasing personal technology use among rural populations provides a new opportunity for health equity. Apps and accelerometers enable connectivity, accountability, and personalization between participants and their coaches. This app includes a decision support system and display that helps participants monitor fruit & vegetable (F/V) intake, moderate-vigorous physical activity, and sedentary screen time relative to their daily target. This daily diet and activity data entry is a core component of the MBC2 intervention rather than an outcome or assessment. The app also transmits this information to a web-based dashboard accessed by coaches, who use it to tailor telephone counseling.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •adults residing in Appalachian Kentucky
- •willingness to use smart phone to record and modify diet and activity
- •willingness to wear an accelerometer
- •consume <4.5 cups fruit/vegetables daily
- •consume >8% daily calories from fat
- •engage in <150 minutes of moderate-intensity physical activity weekly
- •spend >90 minutes daily on non-work, non-education-related sedentary recreational use of screen time.
Exclusion Criteria
- •unstable medical conditions
- •cognitive impairment
- •hospitalization for psychiatric disorder within the last 5 years
- •active suicidal ideation
- •substance use disorder other than nicotine dependence
- •at risk for adverse cardiovascular events with moderate-intensity activity
- •taking weight loss medication
- •trying to get pregnant, pregnant or lactating
- •active eating disorders
- •using mobility assistive devices
- •inability to read study materials
Outcomes
Primary Outcomes
Change in diet and activity
Time Frame: 9 months (at baseline, 3 months and 9 months)
A single composite MBC (Make Better Choices) score of four behaviors (fruit and vegetable intake, fat intake, physical activity, and sedentary screen time) will be used to assess change across multiple diet and activity behaviors. Fruit and vegetable intake, saturated fat intake, and screen time will be measured from smart phone data. Time spent in moderate/vigorous physical activity will be transmitted from the accelerometer to the app. The MBC score, expressing each participant's overall change across the multiple diet and activity behaviors relative to baseline is calculated as the mean of four behavioral individual Z scores at each time point. Scores have an unlimited range; higher values represent greater healthy lifestyle improvement relative to the overall baseline distribution.
Secondary Outcomes
- Change in Blood Pressure(9 months (at baseline, 3 months and 9 months))
- Change in Health-Related Quality of Life(9 months (at baseline, 3 months and 9 months))
- Change in Weight(9 months (at baseline, 3 months and 9 months))
- Change in Body Mass Index (BMI)(9 months (at baseline, 3 months and 9 months))
- Change in Height(9 months (at baseline, 3 months and 9 months))
- Change in Waist Circumference(9 months (at baseline, 3 months and 9 months))
Investigators
Nancy Schoenberg
Professor
University of Kentucky