Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention

Not Applicable

Active, not recruiting

• Conditions: Child Obesity
• Interventions: Behavioral: Contact Control Nutrition (C+N); Other: Non-randomized historical control (WLC) assessment only; Behavioral: Parenting Mindfully for Health Nutrition (PMH)

• Registration Number: NCT03950453
• Lead Sponsor: Yale University

Brief Summary

This study will examine the mediator/moderator variables that affect efficacy of a parent stress intervention with nutrition education (PMH+N: parenting mindfully for health) vs. Control intervention with nutrition education (CTL+N) on parent stress, parenting, health behaviors and child obesity risk. A non-randomized historical control group will also be assessed during the intervention and follow-up periods throughout to obtain outcome assessment without any interventions being provided.

Detailed Description

This is a 5-year interdisciplinary project to assess a 12-week Parenting Mindfully for Health (PMH) + nutrition counseling (N) versus contact control intervention (C) + nutrition counseling (N), to examine short-term and long term enduring effects of PMH+N to promote healthy eating and physical activity in parent and child, and prevent childhood obesity risk in 2-5 year olds, via changes in parent stress and parenting. A non-randomized historical control group will also be assessed during the intervention and follow-up periods throughout to obtain outcome assessment without any interventions being provided.

Study Timeline

• Study Start: 2018-11-11
• Study First Submitted: 2019-04-22
• Study First Submitted QC: 2019-05-10
• Study First Posted: 2019-05-15
• Primary Completion: 2023-06-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

• Family with a child between 2-5 years
• BMI of parent ≥30kg/m2
• Parents aged 18 yrs or older
• High parent stress (PSS mean score ≥25)
• Low income family as determined by HHS Poverty Guidelines

Read More

Exclusion Criteria

• Diagnosis of mental retardation, autism or other pervasive developmental disorder for child;
• Current serious psychiatric or medical disorder requiring immediate treatment, including active alcohol or substance use disorders (confirmed by urine toxicology screening and history), psychotic illnesses, suicidal ideation, untreated diabetes, cardiovascular disease, cancers or any other active current illnesses that preclude study participation for child or parent;
• Inadequate English proficiency to complete questionnaires.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contact Control Nutrition (C+N)	Contact Control Nutrition (C+N)	Contact control intervention (C) + nutrition and physical activity counseling (N).
Historical Control (WLC) non-randomized	Non-randomized historical control (WLC) assessment only	Non-randomized, historical control group with only assessments during intervention and follow-up period.
Parenting Mindfully for Health Nutrition (PMH)	Parenting Mindfully for Health Nutrition (PMH)	Parenting Mindfully for Health (PMH) + nutrition and physical activity counseling to promote healthy eating and physical activity in parent and child.

Primary Outcome Measures

Name	Time	Method
Parenting Behavior Change	TWT parenting behavior ratings at Baseline Pre-intervention and at post-intervention (week 12)	Observed parenting behavior ratings for increase in positive parenting behaviors in the Toy Wait Task (TWT)
Child BMI change post intervention and at short term 6 month follow-up	Change from Pre-intervention to post-intervention (week 12) and at 6 month short term follow up	Child height will be measured with a measuring tape. For children, weight and height will be plotted on the CDC growth chart for the child's age to determine the BMI-for-age percentile scores.
Parent Stress change from Pre to Post intervention	Baseline Pre-intervention to Post intervention at 12 weeks	Parent stress measured by the Perceived Stress Scale scores ranging from 0-56 with higher scores indicating more stress.
Child food intake change	Baseline Pre-intervention and at post-intervention (week 12)	Parent report of child food frequency questionnaire assessment of frequency of healthy and unhealthy food intake.

Secondary Outcome Measures

Name	Time	Method
Parent Stress change from Post intervention to follow up period over 24-months	Post intervention at 12 weeks to follow-up timepoints at 6-, 12-, 18- and 24- month timepoints	Parent stress measured by the Perceived Stress Scale scores ranging from 0-56 with higher scores indicating more stress.
Child BMI change at long term term follow-up	Baseline compared to 12-month, 18-month and 24-month timepoint	Child height will be measured with a measuring tape. For children, weight and height will be plotted on the CDC growth chart for the child's age to determine the BMI-for-age percentile scores.
Child food intake change	Baseline Pre-intervention and at post-intervention (week 12)	Parent report of child food frequency questionnaire assessment of frequency of healthy and unhealthy food intake.
Parenting Stress Inventory (PSI)	PSI scores at Baseline Pre-intervention and at post-intervention (week 12) and at follow-ups months 6-, 12-, 18- and 24 month timepoints	Parent reported PSI scores ranging from 18-90 with higher scores indicating higher parenting stress.

Trial Locations

Locations (1)

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