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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
Children aged 3-11 years old and one of their parents with a BMI >25 but less than 45
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 Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a child aged 3-11 with a parent whose BMI is between 25 and 45.

MHFproject Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~changes from baseline to post intervention about 4-6 months after baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and changes from baseline to post intervention about 4-6 months after baseline 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
183 Previous Clinical Trials
601,078 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

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 enrolled in this trial experiment?

"Affirmative. Data hosted on clinicaltrials.gov testifies that this medical experiment, which was first advertised on February 8th 2022, is actively recruiting participants. Approximately 60 patients need to be enrolled from a single research centre."

Answered by AI

Do I qualify to join this experiment?

"In order to be considered for this medical study, applicants must have a diagnosis of obesity as well as fall between the ages of 3 and 6. Currently, 60 participants are needed in total."

Answered by AI

Is this trial currently open to new participants?

"Affirmative. According to the details found on clinicaltrials.gov, this trial is actively searching for participants. It was first published on February 8th 2022 and has since been revised as recently as August 22nd of that year. A total of 60 volunteers are required at a single location."

Answered by AI

Are minors being admitted as participants for this research?

"The parameters for participation in this trial require that individuals be between 3 to 6 years of age. This research is targeting 54 minors and 207 elderly people."

Answered by AI

Who else is applying?

What site did they apply to?
Michigan State University
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Hi ,I tried to put my correct address in it's 813 E Fairplains St Apt 2 Greenville Michigan 48838.
PatientReceived no prior treatments
~16 spots leftby Mar 2025