Recruiting

Health Coaching

Sponsor:

Nancy Schoenberg

Code:

NCT04309461

Conditions

Health Behavior

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Stress Management Control

Adapted MBC2 Program

Study Details

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

Study ID

NCT04309461

Start date

Aug 1, 2020

Status verified date

Nov, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

279 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Stress Management Group

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.

experimental: Adapted MBC2 Group

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.

Interventions

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.

Primary outcome measure

  • Change in diet and activity [ Time Frame: 9 months (at baseline, 3 months and 9 months) ]

Central Contacts and Locations

Central contacts

Susan C Westneat, MA

859 323 8282swest1@email.uky.edu

Locations

MBC2 Field Office University of Kentucky

Recruiting

Benham, Kentucky, United States, 40807

Contacts

Deanna Sherman

(606) 894-0355dleesherman@uky.edu

More Information

Sponsor

Nancy Schoenberg

Last update posted

Nov 10, 2026

Last verified

Nov, 2026

Keywords

  • app
  • coaching
  • Appalachian

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by Nancy Schoenberg on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.