NCT01974102

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

April 6, 2021

Completed
Last Updated

April 6, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

October 27, 2013

Results QC Date

April 16, 2020

Last Update Submit

March 10, 2021

Conditions

Parental StressParent and Child StressParental and Child ObesityChild Obesity

Outcome Measures

Primary Outcomes (1)

  • Attendance

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

    8 weeks

Secondary Outcomes (1)

  • Change in BMI Percentile

    8 weeks

Study Arms (2)

lifestyle

ACTIVE COMPARATOR

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.

Behavioral: Lifestyle counseling

therapy

EXPERIMENTAL

Active group will receive weekly mindfulness based parenting stress reduction (PMH) plus nutrition and physical activity counseling for 8 weeks.

Behavioral: Lifestyle counselingBehavioral: Parenting Mindfully for Health (PMH)

Interventions

Lifestyle counselingBEHAVIORAL

Active control group will receive weekly session for viewing relaxing video and discussion plus nutritional and physical activity counseling for 8 weeks.

lifestyletherapy
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.

therapy

Eligibility Criteria

Age2 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Stress Center

New Haven, Connecticut, 06519, United States

Location

Related 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.jpeds.2018.07.011. Epub 2018 Sep 18.

    PMID: 30241766RESULT

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Health

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Population Characteristics

Limitations and Caveats

Limitations of this study include the small sample size, limited data on the mothers due to participants' time restraints and preference, and short intervention duration.

Results Point of Contact

Title
Dr. Rajita Sinha
Organization
YALE UNIVERSITY SCHOOL OF MEDICINE
rajita.sinha@yale.edu
2038592840

Study Officials

  • Rajita Sinha, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2013

First Posted

November 1, 2013

Study Start

October 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

April 6, 2021

Results First Posted

April 6, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)