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Healthy Lifestyle Program for Heart Disease Risk Reduction (MBC2 Trial)

N/A

Recruiting

Research Sponsored by Nancy Schoenberg

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

MBC2 Trial Summary

This trial will test a new program to help reduce risk factors for heart disease among adults in Appalachia. The program includes an app, physical activity tracking, health coaching, and behavioral incentives to encourage healthier habits.

Who is the study for?

This trial is for adults living in Appalachian Kentucky who want to improve their health habits. Participants should be willing to use a smartphone app and wear an accelerometer, spend over 90 minutes daily on recreational screen time, eat less than 4.5 cups of fruits/vegetables daily, engage in less than 150 minutes of physical activity weekly, and consume more than 8% of their calories from saturated fat.Check my eligibility

What is being tested?

The study tests the 'Adapted MBC2 Program' which includes an app, accelerometer tracking, health coaching sessions, and incentives aimed at increasing fruit/vegetable intake and physical activity while reducing saturated fat consumption and sedentary screen time among participants.See study design

What are the potential side effects?

Since this intervention involves lifestyle changes rather than medication or medical procedures, side effects may include discomfort adjusting to new diet or exercise routines but are not expected to involve typical drug-related adverse reactions.

MBC2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months (at baseline, 3 months and 9 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months (at baseline, 3 months and 9 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months (at baseline, 3 months and 9 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in diet and activity

Secondary outcome measures

Change in Blood Pressure

Change in Body Mass Index (BMI)

Change in Health-Related Quality of Life

+3 more

Other outcome measures

Change in HDL-C

Change in LDL-C

Change in plasma glucose

+2 more

MBC2 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Adapted MBC2 GroupExperimental Treatment1 Intervention

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.

Group II: Stress Management GroupActive Control1 Intervention

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,837 Previous Clinical Trials

47,851,244 Total Patients Enrolled

7 Trials studying Health Behaviors

582 Patients Enrolled for Health Behaviors

Nancy SchoenbergLead Sponsor

4 Previous Clinical Trials

3,709 Total Patients Enrolled

Media Library

Adapted MBC2 Program Clinical Trial Eligibility Overview. Trial Name: NCT04309461 — N/A

Health Behaviors Research Study Groups: Stress Management Group, Adapted MBC2 Group

Health Behaviors Clinical Trial 2023: Adapted MBC2 Program Highlights & Side Effects. Trial Name: NCT04309461 — N/A

Adapted MBC2 Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT04309461 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are taking part in this research project?

"Affirmative. Per the information showcased on clinicaltrials.gov, this medical trial is currently recruiting participants; it was first uploaded to the site on May 29th 2020 and last edited January 5th 2022. As many as 350 individuals are sought from a single location for enrolment in this study."

Answered by AI

Is there still availability for participants in this clinical trial?

"Affirmative. Records on clinicaltrials.gov verify that enrolment for this medical trial is currently ongoing, having been first posted in May 2020 and last updated in January 2022. 350 patients are necessary across a single research site to complete the study's aims."

Answered by AI

Does this clinical trial permit individuals of advanced age to participate?

"This investigation is seeking out individuals who are at least 18 years of age and not above 100 years old."

Answered by AI

What are the necessary qualifications for enrolling in this research program?

"Potential candidates must have healthy behaviors as well as be within the age range of 18 and 100. This trial has a total recruitment goal of 350 individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Make Better Choices 2 for Rural Appalachians

Nancy Schoenberg 2020. "Make Better Choices 2 for Rural Appalachians". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04309461.