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Mindfulness-Based Stress Reduction for Childhood Obesity

N/A

Waitlist Available

Led By Rajita Sinha

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

BMI of parent ≥30kg/m2

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post intervention at 12 weeks to follow-up timepoints at 6-, 12-, 18- and 24- month timepoints

Awards & highlights

Study Summary

This trial will study how different family compositions, food insecurity, and adversity affect stress levels, parenting, health behaviors, and the risk of child obesity.

Who is the study for?

This trial is for parents over 18 years old from low-income families, with a child aged 2-5. Parents must have a BMI of ≥30kg/m^2 and high stress levels. Families can't join if the parent or child has serious health issues like untreated diabetes, active substance abuse, or certain mental health conditions.Check my eligibility

What is being tested?

The study tests whether a mindfulness-based stress intervention combined with nutrition education (PMH+N) affects parent stress, parenting practices, healthy behaviors, and reduces childhood obesity risk compared to just nutrition education (CTL+N). A third group won't receive any intervention but will be observed for comparison.See study design

What are the potential side effects?

Since this trial focuses on behavioral interventions like mindfulness training and nutritional guidance rather than medication, there are no direct medical side effects expected. However, participants may experience changes in lifestyle habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My BMI is 30 or higher.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post intervention at 12 weeks to follow-up timepoints at 6-, 12-, 18- and 24- month timepoints

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post intervention at 12 weeks to follow-up timepoints at 6-, 12-, 18- and 24- month timepoints

This trial's timeline: 3 weeks for screening, Varies for treatment, and post intervention at 12 weeks to follow-up timepoints at 6-, 12-, 18- and 24- month timepoints for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Child BMI change post intervention and at short term 6 month follow-up

Parent Stress change from Pre to Post intervention

Parenting Behavior Change

Secondary outcome measures

Child BMI change at long term term follow-up

Child food intake change

Parent Stress change from Post intervention to follow up period over 24-months

+1 more

Other outcome measures

Parent BMI

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Parenting Mindfully for Health Nutrition (PMH)Experimental Treatment1 Intervention

Parenting Mindfully for Health (PMH) + nutrition and physical activity counseling to promote healthy eating and physical activity in parent and child.

Group II: Historical Control (WLC) non-randomizedExperimental Treatment1 Intervention

Non-randomized, historical control group with only assessments during intervention and follow-up period.

Group III: Contact Control Nutrition (C+N)Active Control1 Intervention

Contact control intervention (C) + nutrition and physical activity counseling (N).

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,357 Previous Clinical Trials

4,314,940 Total Patients Enrolled

Yale UniversityLead Sponsor

1,847 Previous Clinical Trials

2,737,422 Total Patients Enrolled

Rajita SinhaPrincipal InvestigatorYale University

1 Previous Clinical Trials

86 Total Patients Enrolled

Media Library

Parenting Mindfully for Health Nutrition (PMH) Clinical Trial Eligibility Overview. Trial Name: NCT03950453 — N/A

Childhood Obesity Research Study Groups: Historical Control (WLC) non-randomized, Parenting Mindfully for Health Nutrition (PMH), Contact Control Nutrition (C+N)

Childhood Obesity Clinical Trial 2023: Parenting Mindfully for Health Nutrition (PMH) Highlights & Side Effects. Trial Name: NCT03950453 — N/A

Parenting Mindfully for Health Nutrition (PMH) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03950453 — N/A

Frequently Asked Questions

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

Is the trial open to elderly persons aged 80 and above?

"This clinical trial is only available for children between the ages of 2 and 5. There are 250 spots open to younger patients, while 603 slots exist for those over 65 years old."

Answered by AI

Is this exploration currently in search of participants?

"The evidence on clinicaltrials.gov suggests that this medical research is not currently enrolling members; the initial posting was placed on November 11th 2018 and last updated May 9th 2022. However, 1007 other trials are actively recruiting participants at this moment in time."

Answered by AI

Who meets the necessary qualifications to take part in this clinical trial?

"This clinical trial is open to children aged between two and five years old who suffer from pediatric obesity. It currently requires the participation of 285 patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention

2018. "Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03950453.