Family Based Mindfulness Intervention

Child Obesity Clinical Trial

Official title:

Preventing Childhood Obesity Through a Family-Based Mindfulness Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974102
• Other study ID #: 1306012264
• Secondary ID: 5R21AT007708
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: October 2015

Study information

• Verified date: March 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Between ages 18-70 years;

2. Able to read and write (parent)

3. Family with a child between 2-5 years old

4. BMI of parent in obese category

5. High parenting stress (mean score of >=3 on 3 questions from Parenting Stress Index)

Exclusion Criteria:

1. Any psychotic disorder or current psychiatric symptoms for child or parent requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation

2. Diagnosis of mental retardation, autism or other pervasive developmental disorder for child

3. Inability to give informed consent

4. Current serious medical disorder precluding participation in physical activity

Related Conditions & MeSH terms

• Child Obesity
• Obesity
• Parent and Child Stress
• Parental and Child Obesity
• Parental Stress
• Pediatric Obesity

Intervention

Behavioral:
• Lifestyle counseling
Active control group will receive weekly session for viewing relaxing video and discussion plus nutritional and physical activity counseling for 8 weeks.
• Parenting Mindfully for Health (PMH)
Active participants will receive 8 weeks of mindfulness based parenting stress reduction (PMH) plus nutritional and physical activity counseling for 8 weeks.

Locations

Country	Name	City	State
United States	Yale Stress Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.j — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attendance	Attendance rates (average number of sessions) were compared across groups.	8 weeks
Secondary	Change in BMI Percentile	A comparison between groups to determine the impact of the intervention on BMI percentile.	8 weeks