Family Based Mindfulness Intervention

Not Applicable

Completed

• Conditions: Child Obesity; Parent and Child Stress; Parental Stress; Parental and Child Obesity
• Interventions: Behavioral: Lifestyle counseling; Behavioral: Parenting Mindfully for Health (PMH)

• Registration Number: NCT01974102
• Lead Sponsor: Yale University

Brief Summary

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.

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-27
• Study First Submitted QC: 2013-10-31
• Study First Posted: 2013-11-01
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Results First Submitted: 2020-04-16
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-10
• Last Update Submitted: 2021-03-10
• Results First Posted: 2021-04-06
• Last Update Posted: 2021-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lifestyle	Lifestyle counseling	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.
therapy	Lifestyle counseling	Active group will receive weekly mindfulness based parenting stress reduction (PMH) plus nutrition and physical activity counseling for 8 weeks.
therapy	Parenting Mindfully for Health (PMH)	Active group will receive weekly mindfulness based parenting stress reduction (PMH) plus nutrition and physical activity counseling for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Attendance	8 weeks	Attendance rates (average number of sessions) were compared across groups.

Secondary Outcome Measures

Name	Time	Method
Change in BMI Percentile	8 weeks	A comparison between groups to determine the impact of the intervention on BMI percentile.

Trial Locations

Locations (1)

Yale Stress Center; 🇺🇸 New Haven, Connecticut, United States