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Mindfulness-Based Intervention for Obesity (MHFproject Trial)

N/A
Waitlist Available
Led By Tsui-Sui A Kao, PhD
Research Sponsored by Michigan State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline parent's mindful eating scores at 4 -6 months after baseline assessment.
Awards & highlights

MHFproject Trial Summary

This trial will test the feasibility and preliminary efficacy of a mindfulness-based Motivational Interviewing intervention with rural families within Michigan. The study will enroll 34-60 families from Michigan rural or suburban communities with one OW/O parent-figure adult (BMI ≥25) who has at least one child (ages 3-6) at home. The outcome assessments include BMI, %BF, WC, BP, and optional hair cortisol baseline and post-intervention.

Who is the study for?
This trial is for families in rural or suburban Michigan with one overweight/obese parent (BMI between 25 and 45) and a child aged 3-6. Both must enroll together. It's not open to those who are mentally/physically disabled or pregnant women.Check my eligibility
What is being tested?
The study tests a mindfulness-based Motivational Interviewing intervention via online sessions every other week, comparing it to receiving educational materials by mail. Measurements like BMI, body fat percentage, waist circumference, blood pressure, and stress levels will be tracked.See study design
What are the potential side effects?
Since the interventions involve behavioral therapy (mindfulness and motivation techniques) and education rather than medication, significant physical side effects are not expected; however, participants may experience emotional discomfort.

MHFproject Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to post intervention, about 4-6 months after baseline assessment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to post intervention, about 4-6 months after baseline assessment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Parents' Healthy Eating Index (HEI) converted from ASA24
Secondary outcome measures
Centre for Epidemiological Studies Depression Scale (CES-D10)
Child's Physical Activity
Collective family efficacy (parents)
+9 more

MHFproject Trial Design

2Treatment groups
Experimental Treatment
Group I: MM-based MI groupExperimental Treatment1 Intervention
Intervention group parents will receive 9 intervention sessions every other week by trained staff via 9 online sessions via Zoom or phone calls. Each intervention session will last 30-40 minutes. Intervention group parents will receive 3 text messages per week. No in-person contacts will be conducted without MSU department permission. All assessments will be delivered remotely with guided phone calls or zoom conference. The assessment of dyads' BMI, %BF, and WC will be obtained remotely from the parents using the scale and measuring tape delivered to their home.
Group II: Control groupExperimental Treatment1 Intervention
Control group parents will receive a total of 9 emailed packets of educational materials (without information related to the mindfulness-based motivational interviewing [MM-based-MI]). The pre and post assessments will be collected the same way as the participants at intervention group.

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Who is running the clinical trial?

Michigan State UniversityLead Sponsor
187 Previous Clinical Trials
606,923 Total Patients Enrolled
10 Trials studying Obesity
5,135 Patients Enrolled for Obesity
Tsui-Sui A Kao, PhDPrincipal InvestigatorMSU College of Nursing

Media Library

MM-based MI Clinical Trial Eligibility Overview. Trial Name: NCT05324969 — N/A
Obesity Research Study Groups: MM-based MI group, Control group
Obesity Clinical Trial 2023: MM-based MI Highlights & Side Effects. Trial Name: NCT05324969 — N/A
MM-based MI 2023 Treatment Timeline for Medical Study. Trial Name: NCT05324969 — N/A
~15 spots leftby Jun 2025
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