Back to resultsPreventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention
Primary Purpose
Child Obesity
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parenting Mindfully for Health Nutrition (PMH)
Contact Control Nutrition (C+N)
Sponsored by
About this trial
This is an interventional treatment trial for Child Obesity
Eligibility Criteria
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.
Sites / Locations
- The Yale Stress Center: Yale University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Parenting Mindfully for Health Nutrition (PMH)
Contact Control Nutrition (C+N)
Arm Description
Parenting Mindfully for Health (PMH) + nutrition and physical activity counseling to promote healthy eating and physical activity in parent and child.
Contact control intervention (C) + nutrition and physical activity counseling (N).
Outcomes
Primary Outcome Measures
Child BMI
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 BMI
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 BMI
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 BMI
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 BMI
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 BMI
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.
Secondary Outcome Measures
Parent Emotion
Difficulties in Emotion Regulation Scale (DERS) will cover parent report of emotion dysregulation that is particularly sensitive to change related to Mindfulness Based Interventions (MBIs).
Parent Emotion
Difficulties in Emotion Regulation Scale (DERS) will cover parent report of emotion dysregulation that is particularly sensitive to change related to MBIs
Parent Emotion
Difficulties in Emotion Regulation Scale (DERS) will cover parent report of emotion dysregulation that is particularly sensitive to change related to MBIs
Parent Emotion
Difficulties in Emotion Regulation Scale (DERS) will cover parent report of emotion dysregulation that is particularly sensitive to change related to MBIs
Parent Emotion
Difficulties in Emotion Regulation Scale (DERS) will cover parent report of emotion dysregulation that is particularly sensitive to change related to MBIs
Parent Emotion
Difficulties in Emotion Regulation Scale (DERS) will cover parent report of emotion dysregulation that is particularly sensitive to change related to MBIs
Parent Mindfulness
The Interpersonal Mindfulness in Parenting Scale (IM-P) Mindfulness Attention Awareness Scale (MAAS) have sensitivity to mindful parenting intervention effects.
Parent Mindfulness
The Interpersonal Mindfulness in Parenting Scale (IM-P) Mindfulness Attention Awareness Scale (MAAS) have sensitivity to mindful parenting intervention effects.
Parent Mindfulness
The Interpersonal Mindfulness in Parenting Scale (IM-P) Mindfulness Attention Awareness Scale (MAAS) have sensitivity to mindful parenting intervention effects.
Parent Mindfulness
The Interpersonal Mindfulness in Parenting Scale (IM-P) Mindfulness Attention Awareness Scale (MAAS) have sensitivity to mindful parenting intervention effects.
Parent Mindfulness
The Interpersonal Mindfulness in Parenting Scale (IM-P) Mindfulness Attention Awareness Scale (MAAS) have sensitivity to mindful parenting intervention effects.
Parent Mindfulness
The Interpersonal Mindfulness in Parenting Scale (IM-P) Mindfulness Attention Awareness Scale (MAAS) have sensitivity to mindful parenting intervention effects.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03950453
Brief Title
Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention
Official Title
Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 11, 2018 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study will examine the mediator/moderator variables of family composition, food insecurity, adversity and emotion regulation for effects on parent stress, parenting, health behaviors and child obesity risk.
Detailed Description
This is a 5-year interdisciplinary project to assess a 12-week Parenting Mindfully for Health (PMH) + nutrition and physical activity counseling (N) versus contact control intervention (C) + nutrition and physical activity 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
cohort study
Masking
ParticipantOutcomes Assessor
Masking Description
participant and outcomes assessor
Allocation
Randomized
Enrollment
285 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parenting Mindfully for Health Nutrition (PMH)
Arm Type
Experimental
Arm Description
Parenting Mindfully for Health (PMH) + nutrition and physical activity counseling to promote healthy eating and physical activity in parent and child.
Arm Title
Contact Control Nutrition (C+N)
Arm Type
Active Comparator
Arm Description
Contact control intervention (C) + nutrition and physical activity counseling (N).
Intervention Type
Behavioral
Intervention Name(s)
Parenting Mindfully for Health Nutrition (PMH)
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Contact Control Nutrition (C+N)
Intervention Description
Contact Control Group where parents engage in a quiet, relaxing, but stimulating activity with stress reduction benefits.
Primary Outcome Measure Information:
Title
Child BMI
Description
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.
Time Frame
baseline
Title
Child BMI
Description
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.
Time Frame
at 12 weeks
Title
Child BMI
Description
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.
Time Frame
at 6 month timepoint
Title
Child BMI
Description
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.
Time Frame
12 months
Title
Child BMI
Description
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.
Time Frame
at 18 month timepoint
Title
Child BMI
Description
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.
Time Frame
at 24 month timepoint
Secondary Outcome Measure Information:
Title
Parent Emotion
Description
Difficulties in Emotion Regulation Scale (DERS) will cover parent report of emotion dysregulation that is particularly sensitive to change related to Mindfulness Based Interventions (MBIs).
Time Frame
baseline
Title
Parent Emotion
Description
Difficulties in Emotion Regulation Scale (DERS) will cover parent report of emotion dysregulation that is particularly sensitive to change related to MBIs
Time Frame
at 12 week timepoint
Title
Parent Emotion
Description
Difficulties in Emotion Regulation Scale (DERS) will cover parent report of emotion dysregulation that is particularly sensitive to change related to MBIs
Time Frame
at 6 month timepoint
Title
Parent Emotion
Description
Difficulties in Emotion Regulation Scale (DERS) will cover parent report of emotion dysregulation that is particularly sensitive to change related to MBIs
Time Frame
at 12 month timepoint
Title
Parent Emotion
Description
Difficulties in Emotion Regulation Scale (DERS) will cover parent report of emotion dysregulation that is particularly sensitive to change related to MBIs
Time Frame
at 18 month timepoint
Title
Parent Emotion
Description
Difficulties in Emotion Regulation Scale (DERS) will cover parent report of emotion dysregulation that is particularly sensitive to change related to MBIs
Time Frame
at 24 month timepoint
Title
Parent Mindfulness
Description
The Interpersonal Mindfulness in Parenting Scale (IM-P) Mindfulness Attention Awareness Scale (MAAS) have sensitivity to mindful parenting intervention effects.
Time Frame
baseline
Title
Parent Mindfulness
Description
The Interpersonal Mindfulness in Parenting Scale (IM-P) Mindfulness Attention Awareness Scale (MAAS) have sensitivity to mindful parenting intervention effects.
Time Frame
at 12 week timepoint
Title
Parent Mindfulness
Description
The Interpersonal Mindfulness in Parenting Scale (IM-P) Mindfulness Attention Awareness Scale (MAAS) have sensitivity to mindful parenting intervention effects.
Time Frame
6 months
Title
Parent Mindfulness
Description
The Interpersonal Mindfulness in Parenting Scale (IM-P) Mindfulness Attention Awareness Scale (MAAS) have sensitivity to mindful parenting intervention effects.
Time Frame
at 12 month timepoint
Title
Parent Mindfulness
Description
The Interpersonal Mindfulness in Parenting Scale (IM-P) Mindfulness Attention Awareness Scale (MAAS) have sensitivity to mindful parenting intervention effects.
Time Frame
at 18 month timepoint
Title
Parent Mindfulness
Description
The Interpersonal Mindfulness in Parenting Scale (IM-P) Mindfulness Attention Awareness Scale (MAAS) have sensitivity to mindful parenting intervention effects.
Time Frame
at 24 month timepoint
Other Pre-specified Outcome Measures:
Title
Parent Physical Activity
Description
Physical activity will be measured in parents continuous passive monitoring of steps using a Fitbit fitness monitor (provided to each parent and will replace the pedometers supplied in our PMH R21 pilot), generating measures of sedentary, moderate and vigorous activity allowing for calculation of relative energy expenditure (kcals/kg).
Time Frame
baseline
Title
Parent Physical Activity
Description
Physical activity will be measured in parents continuous passive monitoring of steps using a Fitbit fitness monitor (provided to each parent and will replace the pedometers supplied in our PMH R21 pilot), generating measures of sedentary, moderate and vigorous activity allowing for calculation of relative energy expenditure (kcals/kg).
Time Frame
at 12 week timepoint
Title
Parent Physical Activity
Description
Physical activity will be measured in parents continuous passive monitoring of steps using a Fitbit fitness monitor (provided to each parent and will replace the pedometers supplied in our PMH R21 pilot), generating measures of sedentary, moderate and vigorous activity allowing for calculation of relative energy expenditure (kcals/kg).
Time Frame
at 12 month timepoint
Title
Child Physical Activity
Description
Parent report
Time Frame
at week 6 of the intervention
Title
Child Physical Activity
Description
Parent report
Time Frame
at 12 week timepoint
Title
Metabolic Measures
Description
Parent fasting glucose, insulin, leptin, ghrelin, adiponectin, hemoglobin A1c, C-reactive Protein (CRP) for parent protein, and cholesterol will be assessed for changes in metabolic function with PMH+N vs. C+N interventions.
Time Frame
baseline
Title
Metabolic Measures
Description
Measures of fasting glucose, insulin, leptin, ghrelin, adiponectin, hemoglobin A1c, C-reactive protein, and cholesterol will be assessed for changes in metabolic function with PMH+N vs. C+N interventions.
Time Frame
at 12 month timepoint
Title
Parent BMI
Description
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.
Time Frame
baseline
Title
Parent BMI
Description
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.
Time Frame
at 12 week timepoint
Title
Parent BMI
Description
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.
Time Frame
at 6 month timepoint
Title
Parent BMI
Description
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.
Time Frame
at 12 month timepoint
Title
Parent BMI
Description
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.
Time Frame
at 18 month timepoint
Title
Parent BMI
Description
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.
Time Frame
at 24 month timepoint
Title
Metabolic Measures
Description
Parent fasting glucose, insulin, leptin, ghrelin, adiponectin, hemoglobin A1c, CRP protein, and cholesterol will be assessed for changes in metabolic function with PMH+N vs. C+N interventions.
Time Frame
at 12 week timepoint
Title
Metabolic Measures
Description
Measures of fasting glucose, insulin, leptin, ghrelin, adiponectin, hemoglobin A1c, C-reactive protein, and cholesterol will be assessed for changes in metabolic function with PMH+N vs. C+N interventions.
Time Frame
at 24 month timepoint
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajita Sinha
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Yale Stress Center: Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention
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