Make Better Choices 2 for Rural Appalachians

NCT04309461 | Active Not Recruiting

• 2 other identifiers: 47917R01HL152714
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Behavior

Keywords

app; coaching; Appalachian

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Health-Related Quality of Life

  9 months (at baseline, 3 months and 9 months)

• Change in Blood Pressure

  9 months (at baseline, 3 months and 9 months)

• Change in Weight

  9 months (at baseline, 3 months and 9 months)

• Change in Height

  9 months (at baseline, 3 months and 9 months)

• Change in Body Mass Index (BMI)

  9 months (at baseline, 3 months and 9 months)

Other Outcomes (5)

• Change in total cholesterol

  9 months (at baseline, 3 months and 9 months)

• Change in triglycerides

  9 months (at baseline, 3 months and 9 months)

• Change in HDL-C

  9 months (at baseline, 3 months and 9 months)

Study Arms (2)

Stress Management Group

ACTIVE COMPARATOR

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.

Behavioral: Stress Management Control

Adapted MBC2 Group

EXPERIMENTAL

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.

Behavioral: Adapted MBC2 Program

Interventions

Stress Management Control BEHAVIORAL

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.

Stress Management Group

Adapted MBC2 Program BEHAVIORAL

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.

Adapted MBC2 Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nancy Schoenberg: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

MBC2 Field Office University of Kentucky

Benham, Kentucky, 40807, United States

Location

Related Publications (3)

• Vos SC, Adatorwovor R, Roberts MK, Sherman DL, Bonds D, Dunfee MN, Spring B, Schoenberg NE. Community engagement through social media: A promising low-cost strategy for rural recruitment? J Rural Health. 2024 Jun;40(3):467-475. doi: 10.1111/jrh.12809. Epub 2023 Nov 20.

  PMID: 37985592 DERIVED

• Nichols CE, Davis J. The Women Farmer Stress Inventory: Examining women farmer stress in the United States Corn Belt. J Rural Health. 2024 Jun;40(3):457-466. doi: 10.1111/jrh.12808. Epub 2023 Nov 14.

  PMID: 37962323 DERIVED

• 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.

  PMID: 36348358 DERIVED

MeSH Terms

Conditions

Health Behavior; Alzheimer Disease

Condition Hierarchy (Ancestors)

Behavior; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Nancy Schoenberg, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 16, 2020
• Study Start: August 1, 2020
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)