MBC2 Field Office University of Kentucky
Benham, Kentucky, 40807, United States
NCT Number: NCT04309461
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.
This study is active but is not currently recruiting participants.
18 year–100 year
All sexes
Interventional
Not applicable
Benham, Kentucky, 40807, United States
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.
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 9 months (at baseline, 3 months and 9 months)
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.
Time frame: 9 months (at baseline, 3 months and 9 months)
Sitting total (diastolic and systolic) pressure will be measured according to the CARDIA protocol.
Time frame: 9 months (at baseline, 3 months and 9 months)
Weight will be measured without shoes, wearing a standard hospital gown on a calibrated beam balance scale.
Time frame: 9 months (at baseline, 3 months and 9 months)
Height will be measured using a stadiometer.
Time frame: 9 months (at baseline, 3 months and 9 months)
Body Mass Index (BMI) will be calculated as weight in pounds/ (height in inches)^2) x 704.5 and the difference will be calculated.
Time frame: 9 months (at baseline, 3 months and 9 months)
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.
Time frame: 9 months (at baseline, 3 months and 9 months)
A12 hour fasting blood sample will be collected for a lipid panel and the change in total cholesterol will be calculated.
Time frame: 9 months (at baseline, 3 months and 9 months)
A12 hour fasting blood sample will be collected for a lipid panel and the change in triglycerides will be calculated.
Time frame: 9 months (at baseline, 3 months and 9 months)
A12 hour fasting blood sample will be collected for a lipid panel and the change in HDL-C will be calculated.
Time frame: 9 months (at baseline, 3 months and 9 months)
A12 hour fasting blood sample will be collected for a lipid panel and the change in LDL-C will be calculated.
Time frame: 9 months (at baseline, 3 months and 9 months)
A12 hour fasting blood sample will be collected and the change in glucose will be calculated.
Nancy Schoenberg
Other
Implementing the Make Better Choices 2 mHealth Energy Balance Intervention for Rural Appalachians
Acronym: MBC2
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