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OpenTrials
Completed

NCT Number: NCT01974102

Family Based Mindfulness Intervention

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.

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Key information

Age range

2 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale Stress Center

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Counseling

Behavioral

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)

Behavioral

Active participants will receive 8 weeks of mindfulness based parenting stress reduction (PMH) plus nutritional and physical activity counseling for 8 weeks.

Primary outcomes

  1. Attendance

    Time frame: 8 weeks

    Attendance rates (average number of sessions) were compared across groups.

Secondary outcomes

  1. Change in BMI Percentile

    Time frame: 8 weeks

    A comparison between groups to determine the impact of the intervention on BMI percentile.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Preventing Childhood Obesity Through a Family-Based Mindfulness Intervention

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 1, 2013
Registry last updated
Apr 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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