Family Based Mindfulness Intervention

March 10, 2021 updated by: Yale University

Preventing Childhood Obesity Through a Family-Based Mindfulness Intervention

The goal of the proposed interdisciplinary study is to assess feasibility of recruiting a pilot sample of parents of toddlers and engaging them in a pilot study to test a version of mindfulness-based intervention for parenting stress reduction (PMH), an empirically-supported stress-reduction intervention, plus nutrition and physical activity counseling for parents of preschoolers (aged 2-5); to reduce parent (and child) stress levels; improve parenting; promote healthy eating and physical activity in parent and child; and prevent overweight and obesity in preschoolers with an obese parent.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This project was a preliminary feasibility and pilot efficacy study to assess stressed low income parents of toddlers who were obese to assess whether a mindfulness based parenting intervention (PMH) can reduce their stress, increase parenting and improve family healthy food and physical activity choices. Parents and toddlers also participated in a Toy Wait Task, a behavioral assay of parenting.The empirically-supported stress-reduction intervention, plus nutrition and physical activity counseling (Control) for parents of preschoolers (aged 2-5) was compared to a nutrition and physical activity counseling alone condition to assess whether PMH improved toddler weight, physical activity and parent emotion regulation and healthy eating.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale Stress Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Between ages 18-70 years;
  2. Able to read and write (parent)
  3. Family with a child between 2-5 years old
  4. BMI of parent in obese category
  5. High parenting stress (mean score of >=3 on 3 questions from Parenting Stress Index)

Exclusion Criteria:

  1. Any psychotic disorder or current psychiatric symptoms for child or parent requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation
  2. Diagnosis of mental retardation, autism or other pervasive developmental disorder for child
  3. Inability to give informed consent
  4. Current serious medical disorder precluding participation in physical activity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: lifestyle
Attentional control group will receive weekly meeting to view relaxing video and facilitate discussion along with counseling on nutrition and physical activity for 8 weeks.
Behavioral: Lifestyle counseling
Active control group will receive weekly session for viewing relaxing video and discussion plus nutritional and physical activity counseling for 8 weeks.
Experimental: therapy
Active group will receive weekly mindfulness based parenting stress reduction (PMH) plus nutrition and physical activity counseling for 8 weeks.
Behavioral: Lifestyle counseling
Active control group will receive weekly session for viewing relaxing video and discussion plus nutritional and physical activity counseling for 8 weeks.
Behavioral: Parenting Mindfully for Health (PMH)
Active participants will receive 8 weeks of mindfulness based parenting stress reduction (PMH) plus nutritional and physical activity counseling for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attendance
Time Frame: 8 weeks
Attendance rates (average number of sessions) were compared across groups.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BMI Percentile
Time Frame: 8 weeks
A comparison between groups to determine the impact of the intervention on BMI percentile.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

October 27, 2013

First Submitted That Met QC Criteria

October 31, 2013

First Posted (Estimate)

November 1, 2013

Study Record Updates

Last Update Posted (Actual)

April 6, 2021

Last Update Submitted That Met QC Criteria

March 10, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1306012264
  • 5R21AT007708 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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