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Health BehaviorMBC2NCT04309461

Make Better Choices 2 for Rural Appalachians

A study testing Adapted MBC2 Program in people with Health Behavior, run by Nancy Schoenberg at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Health Behavior
What is being tested?
Adapted MBC2 Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
279 participants
Where
1 siteUnited States
Study dates
1 Aug 2020to Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • taking weight loss medication
  • trying to get pregnant, pregnant or lactating
  • active eating disorders
  • using mobility assistive devices
  • inability to read study materials

Trial locations and contacts

1 site in 1 country.

United States1 site
  • MBC2 Field Office University of Kentucky

    Benham, Kentucky, 40807

Other trials in United States

About this study

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

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.

Read the 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).
Conditions
Health Behavior
Being tested
Stress Management Control, Adapted MBC2 Program
Keywords
app, coaching, Appalachian
Medical subject headings
Health Behavior, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stress Management ControlBehavioural

    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 ProgramBehavioural

    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.

Study groups in NCT04309461
Study groupRoleWhat they receive
Stress Management GroupActive comparatorThe 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.
Receives: Behavioral: Stress Management Control
Adapted MBC2 GroupExperimentalThe 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.
Receives: Behavioral: Adapted MBC2 Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)
  1. 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.

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

  2. Change in Blood Pressure

    Sitting total (diastolic and systolic) pressure will be measured according to the CARDIA protocol.

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

  3. Change in Weight

    Weight will be measured without shoes, wearing a standard hospital gown on a calibrated beam balance scale.

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

  4. Change in Height

    Height will be measured using a stadiometer.

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

  5. 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.

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

  6. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2020
  2. Study start1 Aug 2020
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
279 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04309461
Sponsor's protocol ID
47917
Other IDs
R01HL152714
Acronym
MBC2
Status last verified
Jan 2026
First submitted
12 Mar 2020
Last updated
20 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37985592
  • 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.

    PubMed 37962323
  • 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.

    PubMed 36348358

Questions about this trial

What is this clinical trial studying?

A study testing Adapted MBC2 Program in people with Health Behavior, run by Nancy Schoenberg at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in diet and activity (time frame: 9 months (at baseline, 3 months and 9 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04309461, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.

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