This trial has been completed.

Conditions parental stress, parent and child stress, parental and child obesity, child obesity
Treatments lifestyle counseling, mindfulness based stress reduction
Sponsor Yale University
Collaborator National Center for Complementary and Integrative Health (NCCIH)
Start date October 2013
End date October 2015
Trial size 74 participants
Trial identifier NCT01974102, 1306012264, 5R21AT007708


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 stress reduction (MBSR), 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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Both active and control groups will receive counseling on nutrition and physical activity.
lifestyle counseling
Active and control participants will receive nutritional and physical activity counseling.
Active group will receive 8 weeks of mindfulness based stress reduction therapy
lifestyle counseling
Active and control participants will receive nutritional and physical activity counseling.
mindfulness based stress reduction
Active participants will receive 8 weeks of Mindfulness Based Stress Reduction therapy.

Primary Outcomes

To test feasibility and acceptability of Mindfulness Based Stress Reduction + nutritional and physical activity counseling (MBSR + N).
time frame: 2 years from start of study

Secondary Outcomes

To test initial efficacy and obtain effect sizes for MBSR + N in preventing child overweight.
time frame: 2 years from start of study

Eligibility Criteria

Male or female participants from 2 years up to 70 years old.

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

Additional Information

Official title Preventing Childhood Obesity Through a Family-Based Mindfulness Intervention
Principal investigator Rajita Sinha, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Yale University.