Clinical trial NCT01974102: Family Based Mindfulness Intervention
Official title: Preventing Childhood Obesity Through a Family-Based Mindfulness Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parental Stress
Parent and Child Stress
Parental and Child Obesity
Child Obesity
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2013-11-01
Enrollment: 42
Sex: ALL
Minimum age (years): 2
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Attendance
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in BMI Percentile
timeFrame: 8 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Stress Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Rajita Sinha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.