Not a traditional drug phase: Stress Management Control for Health Behavior
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.
Official registry: https://clinicaltrials.gov/study/NCT04309461 · Nancy Schoenberg · enrollment listed as 279
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Stress Management Control, or Adapted MBC2 Program. The registry lists allocation as randomized. 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.
They plan to enroll about 279 people at Benham. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.
Official title (unrewritten)
Implementing the Make Better Choices 2 mHealth Energy Balance Intervention for Rural Appalachians
Interventions: Stress Management Control, Adapted MBC2 Program
Primary outcome (registry wording): Change in diet and activity
Who it is for (from inclusion criteria)
- Ages 18 Years to 100 Years
- 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 the registry excludes
- 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
Public study contact (from the registry)
Susan C Westneat, MA
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- MBC2 Field Office University of Kentucky — Benham, Kentucky (recruiting)
FAQ about this NCT record
Is NCT04309461 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT04309461?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT04309461?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary