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Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention

Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03950453
Enrollment
246
Registered
2019-05-15
Start date
2018-11-11
Completion date
2024-10-31
Last updated
2024-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Obesity

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.

Interventions

BEHAVIORALParenting Mindfully for Health Nutrition (PMH)

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)

BEHAVIORALContact Control Nutrition (C+N)

Contact Control Group where parents engage in a quiet, relaxing, but stimulating activity and also nutrition counseling.

OTHERNon-randomized historical control (WLC) assessment only

Non-randomized, historical control group with only assessments during intervention and follow-up period.

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

participant and outcomes assessor

Intervention model description

cohort study

Eligibility

Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Parenting Behavior ChangeTWT 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)
Parent Stress change from Pre to Post interventionBaseline Pre-intervention to Post intervention at 12 weeksParent stress measured by the Perceived Stress Scale scores ranging from 0-56 with higher scores indicating more stress.
Child BMI change post intervention and at short term 6 month follow-upChange from Pre-intervention to post-intervention (week 12) and at 6 month short term follow upChild 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 changeBaseline 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

MeasureTime frameDescription
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 timepointsParent reported PSI scores ranging from 18-90 with higher scores indicating higher parenting stress.
Parent Stress change from Post intervention to follow up period over 24-monthsPost intervention at 12 weeks to follow-up timepoints at 6-, 12-, 18- and 24- month timepointsParent 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-upBaseline compared to 12-month, 18-month and 24-month timepointChild 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 changeBaseline Pre-intervention and at post-intervention (week 12)Parent report of child food frequency questionnaire assessment of frequency of healthy and unhealthy food intake.

Other

MeasureTime frameDescription
Parent BMIbaselineParent 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026