Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention
2 other identifiers
interventional
246
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 11, 2018
CompletedFirst Submitted
Initial submission to the registry
April 22, 2019
CompletedFirst Posted
Study publicly available on registry
May 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedFebruary 15, 2024
February 1, 2024
4.6 years
April 22, 2019
February 13, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (4)
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
Child BMI change at long term term follow-up
Baseline compared to 12-month, 18-month and 24-month timepoint
Child food intake change
Baseline Pre-intervention and at post-intervention (week 12)
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
Other Outcomes (6)
Parent BMI
baseline
Parent BMI
at 12 week timepoint
Parent BMI
at 6 month timepoint
- +3 more other outcomes
Study Arms (3)
Parenting Mindfully for Health Nutrition (PMH)
EXPERIMENTALParenting Mindfully for Health (PMH) + nutrition and physical activity counseling to promote healthy eating and physical activity in parent and child.
Contact Control Nutrition (C+N)
ACTIVE COMPARATORContact control intervention (C) + nutrition and physical activity counseling (N).
Historical Control (WLC) non-randomized
OTHERNon-randomized, historical control group with only assessments during intervention and follow-up period.
Interventions
PMH will include included the following components: 1. mindfulness strategies as outlined in the MBSR manual, 2. mindful parenting concepts, 3. mindful eating and awareness of family choices; 4. self and child monitoring of food intake, PA and emotional reactivity; 5. utilizing mindfulness for emotion regulation and distress tolerance, 6. behavioral strategies of goal setting and implementing increasing frequency of healthy food intake and physical activity (PA)
Contact Control Group where parents engage in a quiet, relaxing, but stimulating activity and also nutrition counseling.
Non-randomized, historical control group with only assessments during intervention and follow-up period.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Yale Stress Center: Yale University
New Haven, Connecticut, 06519, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rajita Sinha
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- participant and outcomes assessor
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2019
First Posted
May 15, 2019
Study Start
November 11, 2018
Primary Completion
June 30, 2023
Study Completion
October 31, 2024
Last Updated
February 15, 2024
Record last verified: 2024-02