Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention

Child Obesity Clinical Trial

Official title:

Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03950453
• Other study ID #: 2000023271
• Secondary ID: 1R01DK117651-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 11, 2018
• Est. completion date: October 31, 2024

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 246
• Est. completion date: October 31, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child Obesity
• Obesity
• Pediatric Obesity

Intervention

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)
• Contact Control Nutrition (C+N)
Contact Control Group where parents engage in a quiet, relaxing, but stimulating activity and also nutrition counseling.

Other:
• Non-randomized historical control (WLC) assessment only
Non-randomized, historical control group with only assessments during intervention and follow-up period.

Locations

Country	Name	City	State
United States	The Yale Stress Center: Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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)
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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