Family Based Mindfulness Intervention

NCT ID: NCT01974102

Last Updated: 2021-04-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Parental Stress Parent and Child Stress Parental and Child Obesity Child Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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lifestyle

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.

Group Type ACTIVE_COMPARATOR

Lifestyle counseling

Intervention Type BEHAVIORAL

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

therapy

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

Group Type EXPERIMENTAL

Lifestyle counseling

Intervention Type 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)

Intervention Type BEHAVIORAL

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

Interventions

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Lifestyle counseling

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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rajita Sinha, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale Stress Center

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 30241766 (View on PubMed)

Other Identifiers

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5R21AT007708

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1306012264

Identifier Type: -

Identifier Source: org_study_id

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