Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Child Obesity
• Intervention / Treatment: Behavioral: Parenting Mindfully for Health Nutrition (PMH); Behavioral: Contact Control Nutrition (C+N); Other: Non-randomized historical control (WLC) assessment only

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 Type: Interventional
• Enrollment (Actual): 246
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • The Yale Stress Center: Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Parenting Mindfully for Health Nutrition (PMH); PMH will include included the following components: mindfulness strategies as outlined in the MBSR manual,; mindful parenting concepts,; mindful eating and awareness of family choices;; self and child monitoring of food intake, PA and emotional reactivity;; utilizing mindfulness for emotion regulation and distress tolerance,; behavioral strategies of goal setting and implementing increasing frequency of healthy food intake and physical activity (PA)
Active Comparator: Contact Control Nutrition (C+N); Contact control intervention (C) + nutrition and physical activity counseling (N).	Behavioral: Contact Control Nutrition (C+N); Contact Control Group where parents engage in a quiet, relaxing, but stimulating activity and also nutrition counseling.
Other: Historical Control (WLC) non-randomized; Non-randomized, historical control group with only assessments during intervention and follow-up period.	Other: Non-randomized historical control (WLC) assessment only; Non-randomized, historical control group with only assessments during intervention and follow-up period.; Other Names: assessment only group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent Stress change from Pre to Post intervention	Parent stress measured by the Perceived Stress Scale scores ranging from 0-56 with higher scores indicating more stress.	Baseline Pre-intervention to Post intervention at 12 weeks
Child BMI change post intervention and at short term 6 month 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.	Change from Pre-intervention to post-intervention (week 12) and at 6 month short term follow up
Child food intake change	Parent report of child food frequency questionnaire assessment of frequency of healthy and unhealthy food intake.	Baseline Pre-intervention and at post-intervention (week 12)
Parenting Behavior Change	Observed parenting behavior ratings for increase in positive parenting behaviors in the Toy Wait Task (TWT)	TWT parenting behavior ratings at Baseline Pre-intervention and at post-intervention (week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child food intake change	Parent report of child food frequency questionnaire assessment of frequency of healthy and unhealthy food intake.	Baseline Pre-intervention and at post-intervention (week 12)
Parent Stress change from Post intervention to follow up period over 24-months	Parent stress measured by the Perceived Stress Scale scores ranging from 0-56 with higher scores indicating more stress.	Post intervention at 12 weeks to follow-up timepoints at 6-, 12-, 18- and 24- month timepoints
Child BMI change at long term 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.	Baseline compared to 12-month, 18-month and 24-month timepoint
Parenting Stress Inventory (PSI)	Parent reported PSI scores ranging from 18-90 with higher scores indicating higher parenting stress.	PSI scores at Baseline Pre-intervention and at post-intervention (week 12) and at follow-ups months 6-, 12-, 18- and 24 month timepoints

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent BMI	Parent height will be measured with a stadiometer, and parent BMI will be calculated from weight and height. For parents, waist circumference (WC) and percent body fat will also be measured using the TANITA and following the well-established NHBLI and NHANES III protocol.	baseline
Parent BMI	Parent height will be measured with a stadiometer and parent BMI will be calculated from weight and height. For parents, waist circumference (WC) and percent body fat will also be measured using the TANITA and following the well-established NHBLI and NHANES III protocol.	at 12 week timepoint
Parent BMI	Parent height will be measured with a stadiometer and parent BMI will be calculated from weight and height. For parents, waist circumference (WC) and percent body fat will also be measured using the TANITA and following the well-established NHBLI and NHANES III protocol.	at 6 month timepoint
Parent BMI	Parent height will be measured with a stadiometer and parent BMI will be calculated from weight and height. For parents, waist circumference (WC) and percent body fat will also be measured using the TANITA and following the well-established NHBLI and NHANES III protocol.	at 12 month timepoint
Parent BMI	Parent height will be measured with a stadiometer and parent BMI will be calculated from weight and height. For parents, waist circumference (WC) and percent body fat will also be measured using the TANITA and following the well-established NHBLI and NHANES III protocol.	at 18 month timepoint
Parent BMI	Parent height will be measured with a stadiometer and parent BMI will be calculated from weight and height. For parents, waist circumference (WC) and percent body fat will also be measured using the TANITA and following the well-established NHBLI and NHANES III protocol.	at 24 month timepoint

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Rajita Sinha, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2018
• Primary Completion (Actual): June 30, 2023
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 2000023271; 1R01DK117651-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No