Family Based Mindfulness Intervention
Primary Purpose
Parental Stress, Parent and Child Stress, Parental and Child Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle counseling
Parenting Mindfully for Health (PMH)
Sponsored by
About this trial
This is an interventional prevention trial for Parental Stress
Eligibility Criteria
Inclusion Criteria:
- Between ages 18-70 years;
- Able to read and write (parent)
- Family with a child between 2-5 years old
- BMI of parent in obese category
- High parenting stress (mean score of >=3 on 3 questions from Parenting Stress Index)
Exclusion Criteria:
- Any psychotic disorder or current psychiatric symptoms for child or parent requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation
- Diagnosis of mental retardation, autism or other pervasive developmental disorder for child
- Inability to give informed consent
- Current serious medical disorder precluding participation in physical activity
Sites / Locations
- Yale Stress Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
lifestyle
therapy
Arm Description
Attentional control group will receive weekly meeting to view relaxing video and facilitate discussion along with counseling on nutrition and physical activity for 8 weeks.
Active group will receive weekly mindfulness based parenting stress reduction (PMH) plus nutrition and physical activity counseling for 8 weeks.
Outcomes
Primary Outcome Measures
Attendance
Attendance rates (average number of sessions) were compared across groups.
Secondary Outcome Measures
Change in BMI Percentile
A comparison between groups to determine the impact of the intervention on BMI percentile.
Full Information
NCT ID
NCT01974102
First Posted
October 27, 2013
Last Updated
March 10, 2021
Sponsor
Yale University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT01974102
Brief Title
Family Based Mindfulness Intervention
Official Title
Preventing Childhood Obesity Through a Family-Based Mindfulness Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of the proposed interdisciplinary study is to assess feasibility of recruiting a pilot sample of parents of toddlers and engaging them in a pilot study to test a version of mindfulness-based intervention for parenting stress reduction (PMH), an empirically-supported stress-reduction intervention, plus nutrition and physical activity counseling for parents of preschoolers (aged 2-5); to reduce parent (and child) stress levels; improve parenting; promote healthy eating and physical activity in parent and child; and prevent overweight and obesity in preschoolers with an obese parent.
Detailed Description
This project was a preliminary feasibility and pilot efficacy study to assess stressed low income parents of toddlers who were obese to assess whether a mindfulness based parenting intervention (PMH) can reduce their stress, increase parenting and improve family healthy food and physical activity choices. Parents and toddlers also participated in a Toy Wait Task, a behavioral assay of parenting.The empirically-supported stress-reduction intervention, plus nutrition and physical activity counseling (Control) for parents of preschoolers (aged 2-5) was compared to a nutrition and physical activity counseling alone condition to assess whether PMH improved toddler weight, physical activity and parent emotion regulation and healthy eating.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parental Stress, Parent and Child Stress, Parental and Child Obesity, Child Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lifestyle
Arm Type
Active Comparator
Arm Description
Attentional control group will receive weekly meeting to view relaxing video and facilitate discussion along with counseling on nutrition and physical activity for 8 weeks.
Arm Title
therapy
Arm Type
Experimental
Arm Description
Active group will receive weekly mindfulness based parenting stress reduction (PMH) plus nutrition and physical activity counseling for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counseling
Intervention Description
Active control group will receive weekly session for viewing relaxing video and discussion plus nutritional and physical activity counseling for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Parenting Mindfully for Health (PMH)
Intervention Description
Active participants will receive 8 weeks of mindfulness based parenting stress reduction (PMH) plus nutritional and physical activity counseling for 8 weeks.
Primary Outcome Measure Information:
Title
Attendance
Description
Attendance rates (average number of sessions) were compared across groups.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in BMI Percentile
Description
A comparison between groups to determine the impact of the intervention on BMI percentile.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Between ages 18-70 years;
Able to read and write (parent)
Family with a child between 2-5 years old
BMI of parent in obese category
High parenting stress (mean score of >=3 on 3 questions from Parenting Stress Index)
Exclusion Criteria:
Any psychotic disorder or current psychiatric symptoms for child or parent requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation
Diagnosis of mental retardation, autism or other pervasive developmental disorder for child
Inability to give informed consent
Current serious medical disorder precluding participation in physical activity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajita Sinha, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Stress Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30241766
Citation
Jastreboff AM, Chaplin TM, Finnie S, Savoye M, Stults-Kolehmainen M, Silverman WK, Sinha R. Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention: A Randomized Pilot Study. J Pediatr. 2018 Nov;202:136-142.e1. doi: 10.1016/j.jpeds.2018.07.011. Epub 2018 Sep 18.
Results Reference
result
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Family Based Mindfulness Intervention
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