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Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention

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ClinicalTrials.gov Identifier: NCT03950453
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Child Obesity Behavioral: Parenting Mindfully for Health Nutrition (PMH) Behavioral: Contact Control Nutrition (C+N) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: cohort study
Masking: Double (Participant, Care Provider)
Masking Description: double blinded
Primary Purpose: Treatment
Official Title: Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention
Actual Study Start Date : November 11, 2018
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

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:

  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)

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 with stress reduction benefits.




Primary Outcome Measures :
  1. Child BMI [ Time Frame: baseline ]
    Child Height will be measured with a stadiometer. 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.

  2. Parent BMI [ Time Frame: baseline ]
    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.

  3. Child BMI [ Time Frame: at 12 weeks ]
    Child height will be measured with a stadiometer. 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.

  4. Parent BMI [ Time Frame: at 12 week timepoint ]
    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.

  5. Child BMI [ Time Frame: at 6 month timepoint ]
    Child height will be measured with a stadiometer. 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.

  6. Parent BMI [ Time Frame: at 6 month timepoint ]
    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.

  7. Child BMI [ Time Frame: 12 months ]
    Child height will be measured with a stadiometer. 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.

  8. Parent BMI [ Time Frame: at 12 month timepoint ]
    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.

  9. Child BMI [ Time Frame: at 18 month timepoint ]
    Child height will be measured with a stadiometer. 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.

  10. Parent BMI [ Time Frame: at 18 month timepoint ]
    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.

  11. Child BMI [ Time Frame: at 24 month timepoint ]
    Child height will be measured with a stadiometer. 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.

  12. Parent BMI [ Time Frame: at 24 month timepoint ]
    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.

  13. Parent Physical Activity [ Time Frame: baseline ]
    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).

  14. Parent Physical Activity [ Time Frame: at week 6 of the intervention ]
    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).

  15. Parent Physical Activity [ Time Frame: at 12 week timepoint ]
    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).

  16. Parent Physical Activity [ Time Frame: at 6 month timepoint ]
    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).

  17. Parent Physical Activity [ Time Frame: at 12 month timepoint ]
    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).

  18. Parent Physical Activity [ Time Frame: at 18 month timepoint ]
    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).

  19. Parent Physical Activity [ Time Frame: at 24 month timepoint ]
    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).

  20. Child Physical Activity [ Time Frame: baseline ]
    Child will wear an ActiGraph accelerometer (GT3XP-BTL), used successfully by our group (15) and others in preschoolers, worn at all times for the same 7 days at pre- , mid- (week 6) and post-intervention (week 12), which is water-proof and can be worn at all times.

  21. Child Physical Activity [ Time Frame: at week 6 of the intervention ]
    Child will wear an ActiGraph accelerometer (GT3XP-BTL), used successfully by our group (15) and others in preschoolers, worn at all times for the same 7 days at pre- , mid- (week 6) and post-intervention (week 12), which is water-proof and can be worn at all times.

  22. Child Physical Activity [ Time Frame: at 12 week timepoint ]
    Child will wear an ActiGraph accelerometer (GT3XP-BTL), used successfully by our group (15) and others in preschoolers, worn at all times for the same 7 days at pre- , mid- (week 6) and post-intervention (week 12), which is water-proof and can be worn at all times.

  23. Metabolic Measures [ Time Frame: baseline ]
    Measures of 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.

  24. Metabolic Measures [ Time Frame: at 12 week timepoint ]
    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.

  25. Metabolic Measures [ Time Frame: at 12 month timepoint ]
    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.

  26. Metabolic Measures [ Time Frame: at 24 month timepoint ]
    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.

  27. Parent Emotion [ Time Frame: baseline ]
    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).

  28. Parent Emotion [ Time Frame: at 12 week timepoint ]
    Difficulties in Emotion Regulation Scale (DERS) will cover parent report of emotion dysregulation that is particularly sensitive to change related to MBIs

  29. Parent Emotion [ Time Frame: at 6 month timepoint ]
    Difficulties in Emotion Regulation Scale (DERS) will cover parent report of emotion dysregulation that is particularly sensitive to change related to MBIs

  30. Parent Emotion [ Time Frame: at 12 month timepoint ]
    Difficulties in Emotion Regulation Scale (DERS) will cover parent report of emotion dysregulation that is particularly sensitive to change related to MBIs

  31. Parent Emotion [ Time Frame: at 18 month timepoint ]
    Difficulties in Emotion Regulation Scale (DERS) will cover parent report of emotion dysregulation that is particularly sensitive to change related to MBIs

  32. Parent Emotion [ Time Frame: at 24 month timepoint ]
    Difficulties in Emotion Regulation Scale (DERS) will cover parent report of emotion dysregulation that is particularly sensitive to change related to MBIs

  33. Parent Mindfulness [ Time Frame: baseline ]
    The Interpersonal Mindfulness in Parenting Scale (IM-P) Mindfulness Attention Awareness Scale (MAAS) have sensitivity to mindful parenting intervention effects.

  34. Parent Mindfulness [ Time Frame: at 12 week timepoint ]
    The Interpersonal Mindfulness in Parenting Scale (IM-P) Mindfulness Attention Awareness Scale (MAAS) have sensitivity to mindful parenting intervention effects.

  35. Parent Mindfulness [ Time Frame: 6 months ]
    The Interpersonal Mindfulness in Parenting Scale (IM-P) Mindfulness Attention Awareness Scale (MAAS) have sensitivity to mindful parenting intervention effects.

  36. Parent Mindfulness [ Time Frame: at 12 month timepoint ]
    The Interpersonal Mindfulness in Parenting Scale (IM-P) Mindfulness Attention Awareness Scale (MAAS) have sensitivity to mindful parenting intervention effects.

  37. Parent Mindfulness [ Time Frame: at 18 month timepoint ]
    The Interpersonal Mindfulness in Parenting Scale (IM-P) Mindfulness Attention Awareness Scale (MAAS) have sensitivity to mindful parenting intervention effects.

  38. Parent Mindfulness [ Time Frame: at 24 month timepoint ]
    The Interpersonal Mindfulness in Parenting Scale (IM-P) Mindfulness Attention Awareness Scale (MAAS) have sensitivity to mindful parenting intervention effects.



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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950453


Contacts
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Contact: Rajita Sinha, PhD 203-737-5805 rajita.sinha@yale.edu
Contact: Julie Pinto, MS 203-737-6402 julie.pinto@yale.edu

Locations
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United States, Connecticut
The Yale Stress Center: Yale University Recruiting
New Haven, Connecticut, United States, 06519
Contact: Rachel Hart, MS    203-737-4791    rachel.hart@yale.edu   
Principal Investigator: Rajita Sinha, PhD         
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Rajita Sinha Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03950453     History of Changes
Other Study ID Numbers: 2000023271
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms