Clinical trial NCT04309461: Make Better Choices 2 for Rural Appalachians
Official title: Implementing the Make Better Choices 2 MHealth Energy Balance Intervention for Rural Appalachians
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Behavior
Keywords: app
coaching
Appalachian
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-03-16
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

1. 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.

   During the in-person training, participants will be given materials to help in portion size estimation, plus reminders that entries are time and date-stamped to encourage prompt entry. The app involves automatic wireless data uploading, which enables detection of entry error or non-adherence to protocols. Additional procedures to support adherence to personal goals include: a) visual thermometers to provide feedback about intake and expenditure relative to targets; b) ability to access smart phone diet and activity databases to support decision-making about diet and activity choices; c) visual feedback about goal progress throughout the day to guide self-regulation; and d) use of stepped goals to facilitate incremental attainment of targets. Diet and activity data to assess intervention effectiveness will additionally be collected at the assessment periods via REDCap (baseline and months 3 and 9).
2. Accelerometer: Activity monitors also enhance accountability. Our prior work shows that Appalachian residents have high levels of adherence and satisfaction with accelerometers. For the proposed study, participants will be given a gold standard accelerometer, the triaxial Actigraph GT9X. They will wear it on the non-dominant wrist daily during the intervention. The accelerometer collects data on three axes at a 100 Hz sampling rate, which will be sent via API (application program interface) to display minutes of MVPA (moderate-to-vigorous physical activity) on the study smart phone application as feedback to the participant.
3. Telephone coaching has demonstrated scalability (particularly in more isolated rural locations), effectiveness, and greater reach than in-person counseling. In addition to these benefits, during preparatory focus groups, Appalachians indicated that they prefer telephone coaching over group meetings (due to lack of privacy, time-consuming trips) or home visits (too intrusive). Despite these benefits, telephone coaching is associated with more modest behavioral changes that can undermine longer-term behavior change.
4. Behavioral incentives: An incentive is provided weekly to participants in both conditions if their behavioral average meets goal criterion for the correct use of the app (for data collection) and adherence to behavioral targets (F/V consumption, physical activity and sedentary activity or stress management).

Eligibility criteria: 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

Primary outcomes:
measure: Change in diet and activity
timeFrame: 9 months (at baseline, 3 months and 9 months)
Secondary outcomes:
measure: Change in Health-Related Quality of Life
timeFrame: 9 months (at baseline, 3 months and 9 months)
measure: Change in Blood Pressure
timeFrame: 9 months (at baseline, 3 months and 9 months)
measure: Change in Weight
timeFrame: 9 months (at baseline, 3 months and 9 months)
measure: Change in Height
timeFrame: 9 months (at baseline, 3 months and 9 months)
measure: Change in Body Mass Index (BMI)
timeFrame: 9 months (at baseline, 3 months and 9 months)
measure: Change in Waist Circumference
timeFrame: 9 months (at baseline, 3 months and 9 months)
Other outcomes:
measure: Change in total cholesterol
timeFrame: 9 months (at baseline, 3 months and 9 months)
measure: Change in triglycerides
timeFrame: 9 months (at baseline, 3 months and 9 months)
measure: Change in HDL-C
timeFrame: 9 months (at baseline, 3 months and 9 months)
measure: Change in LDL-C
timeFrame: 9 months (at baseline, 3 months and 9 months)
measure: Change in plasma glucose
timeFrame: 9 months (at baseline, 3 months and 9 months)
Locations:
city: Benham
country: United States
facility: MBC2 Field Office
state: Kentucky
Study officials:
References:
citation: Schoenberg NE, Sherman D, Pfammatter AF, Roberts MK, Chih MY, Vos SC, Spring B. Adaptation and study protocol of the evidence-based Make Better Choices (MBC2) multiple diet and activity change intervention for a rural Appalachian population. BMC Public Health. 2022 Nov 8;22(1):2043. doi: 10.1186/s12889-022-14475-0.