Make Better Choices 2 for Rural Appalachians

Health Behavior Clinical Trial

— MBC2  

Official title:

Implementing the Make Better Choices 2 mHealth Energy Balance Intervention for Rural Appalachians

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04309461
• Other study ID #: 47917
• Secondary ID: R01HL152714
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: University of Kentucky
• Contact: Susan C Westneat, MA
• Phone: 859 323 8282
• Email: swest1[@]email.uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Behavior

Intervention

Behavioral:
• Stress Management Control
The Stress Management Program will utilize a smart phone app, accelerometers, telephone coaching, and behavioral incentives to target stress, relaxation, and sleep. Participants will wear accelerometers, log hours slept, enter real-time information about their relaxation exercises and stress, and monitor 3 goal thermometers (sleep, relaxation, stress) to meet behavioral targets. The Stress Management Program, including the use of the app and assessments, is identical to the Adapted MBC2 program, with the exception of the content.
• Adapted MBC2 Program
The Adapted MBC2 Program will utilize a smart phone app, accelerometers, telephone coaching, and behavioral incentives to target fruit and vegetable intake, dietary fat intake, physical activity, and high sedentary leisure screen time. Participants will wear accelerometers, log hours slept, enter real-time information about their relaxation exercises and stress, and monitor goal thermometers to meet targets.

Locations

Country	Name	City	State
United States	MBC2 Field Office	Benham	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Nancy Schoenberg	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in total cholesterol	A12 hour fasting blood sample will be collected for a lipid panel and the change in total cholesterol will be calculated.	9 months (at baseline, 3 months and 9 months)
Other	Change in triglycerides	A12 hour fasting blood sample will be collected for a lipid panel and the change in triglycerides will be calculated.	9 months (at baseline, 3 months and 9 months)
Other	Change in HDL-C	A12 hour fasting blood sample will be collected for a lipid panel and the change in HDL-C will be calculated.	9 months (at baseline, 3 months and 9 months)
Other	Change in LDL-C	A12 hour fasting blood sample will be collected for a lipid panel and the change in LDL-C will be calculated.	9 months (at baseline, 3 months and 9 months)
Other	Change in plasma glucose	A12 hour fasting blood sample will be collected and the change in glucose will be calculated.	9 months (at baseline, 3 months and 9 months)
Primary	Change in diet and activity	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.	9 months (at baseline, 3 months and 9 months)
Secondary	Change in Health-Related Quality of Life	The SF-36 (Short Form-36) Health Outcomes Survey will be used to assess patient-reported health. The SF-36 consists of 8 scaled scores, which are weighted sums of the questions in their section. Scores range from 0-100; lower scores indicate more disability.	9 months (at baseline, 3 months and 9 months)
Secondary	Change in Blood Pressure	Sitting total (diastolic and systolic) pressure will be measured according to the CARDIA protocol.	9 months (at baseline, 3 months and 9 months)
Secondary	Change in Weight	Weight will be measured without shoes, wearing a standard hospital gown on a calibrated beam balance scale.	9 months (at baseline, 3 months and 9 months)
Secondary	Change in Height	Height will be measured using a stadiometer.	9 months (at baseline, 3 months and 9 months)
Secondary	Change in Body Mass Index (BMI)	Body Mass Index (BMI) will be calculated as weight in pounds/ (height in inches)^2) x 704.5 and the difference will be calculated.	9 months (at baseline, 3 months and 9 months)
Secondary	Change in Waist Circumference	Waist circumference will be assessed twice during expiration, taking the average for analyses, by positioning an anthropometric tape midway between the palpated iliac crest and the palpated lowest rib margin in the mid-axillary lines.	9 months (at baseline, 3 months and 9 months)