Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention

NCT03950453 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2024-02-15

No results posted yet for this study

Summary

This study will examine the mediator/moderator variables that affect efficacy of a parent stress intervention with nutrition education (PMH+N: parenting mindfully for health) vs. Control intervention with nutrition education (CTL+N) on parent stress, parenting, health behaviors and child obesity risk. A non-randomized historical control group will also be assessed during the intervention and follow-up periods throughout to obtain outcome assessment without any interventions being provided.

Conditions

  • Child Obesity

Interventions

BEHAVIORAL

Parenting Mindfully for Health Nutrition (PMH)

PMH will include included the following components: 1. mindfulness strategies as outlined in the MBSR manual, 2. mindful parenting concepts, 3. mindful eating and awareness of family choices; 4. self and child monitoring of food intake, PA and emotional reactivity; 5. utilizing mindfulness for emotion regulation and distress tolerance, 6. behavioral strategies of goal setting and implementing increasing frequency of healthy food intake and physical activity (PA)

BEHAVIORAL

Contact Control Nutrition (C+N)

Contact Control Group where parents engage in a quiet, relaxing, but stimulating activity and also nutrition counseling.

OTHER

Non-randomized historical control (WLC) assessment only

Non-randomized, historical control group with only assessments during intervention and follow-up period.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH
  • Yale University

    lead OTHER

Principal Investigators

  • Rajita Sinha · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-11
Primary Completion
2023-06-30
Completion
2024-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03950453 on ClinicalTrials.gov