What side effects are associated with this type of intervention?

Common treatments for health behaviors, such as multi-component lifestyle interventions involving dietary changes, physical activity, and behavioral counseling, generally have mild side effects. Dietary changes can sometimes lead to gastrointestinal discomfort, such as bloating or constipation, as the body adjusts to new foods. Increased physical activity may result in muscle soreness or fatigue, particularly in individuals who are not accustomed to regular exercise. Behavioral counseling is typically well-tolerated, but some individuals may experience emotional discomfort as they confront and modify long-standing habits. Overall, these side effects are usually temporary and manageable.

What prior FDA approvals exist?

The FDA has approved several treatments for health behaviors that involve behavioral modification and monitoring. For binge eating disorder, lisdexamfetamine dimesylate has been approved, demonstrating efficacy in reducing binge episodes. In smoking cessation, varenicline and combination therapies have shown effectiveness in helping individuals quit smoking. For diabetes management, intensive multifactorial treatment regimens, including lifestyle interventions, have been associated with improved outcomes in blood sugar control and reduced cardiovascular risks. These treatments highlight the importance of integrating behavioral modification and monitoring in managing health behaviors.

What other types of research exist?

Promising, novel alternatives to Multi-component Lifestyle Intervention for health behaviors include: 1) Mobile phone text messaging and app-based interventions, which have shown effectiveness in smoking cessation. 2) Internet-based interventions, including social network platforms like Facebook and Twitter, which provide support and motivation for quitting smoking. 3) Digital Cognitive Behavioral Therapy for Insomnia (CBT-I), which can aid in discontinuing hypnotics and improving sleep-related quality of life. 4) Telehealth programs that offer remote monitoring and personalized feedback for various health behaviors. 5) Integrated care models that combine nurse counseling with nicotine replacement therapy (NRT) for comprehensive tobacco treatment.

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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

Must not have

Using mobility assistive devices

Cognitive impairment

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the MBC2 program, which uses an app, fitness tracker, health coaching, and rewards to improve diet and exercise habits. It targets adults in rural Appalachia, Kentucky who have poor health profiles. The program helps participants track their habits, get personalized advice, and earn rewards for meeting health goals.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I use devices to help me move around.

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I have difficulty with memory or thinking clearly.

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I am currently having thoughts about harming myself.

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I am currently taking medication to lose weight.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in diet and activity

Secondary study objectives

Change in Blood Pressure

Change in Body Mass Index (BMI)

Change in Health-Related Quality of Life

+3 more

Other study objectives

Change in HDL-C

Change in LDL-C

Change in plasma glucose

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for health behaviors, such as those in multi-component lifestyle interventions, work through behavioral modification and monitoring. Behavioral modification techniques like cognitive-behavioral therapy (CBT), motivational interviewing, and mindfulness aim to change unhealthy behaviors by altering thought patterns, increasing motivation, and enhancing self-awareness. Monitoring involves tools like apps, accelerometers, and regular follow-ups to track progress and provide feedback. These mechanisms are crucial as they help identify and modify unhealthy behaviors while offering continuous support and accountability, essential for long-term behavior change and improved health outcomes.

Delineating mechanisms of change in child and adolescent therapy: methodological issues and research recommendations.