Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention

Yale University

Status: Active, not recruiting

Conditions: Child Obesity

Treatments: Behavioral: Parenting Mindfully for Health Nutrition (PMH); Behavioral: Contact Control Nutrition (C+N); Other: Non-randomized historical control (WLC) assessment only

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03950453

1R01DK117651-01A1 (U.S. NIH Grant/Contract)

2000023271

Details and patient eligibility

About

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.

Full description

This is a 5-year interdisciplinary project to assess a 12-week Parenting Mindfully for Health (PMH) + nutrition counseling (N) versus contact control intervention (C) + nutrition counseling (N), to examine short-term and long term enduring effects of PMH+N to promote healthy eating and physical activity in parent and child, and prevent childhood obesity risk in 2-5 year olds, via changes in parent stress and parenting. 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.

Enrollment: 246 patients

Sex: All

Ages: 2 to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Family with a child between 2-5 years
• BMI of parent ≥30kg/m2
• Parents aged 18 yrs or older
• High parent stress (PSS mean score ≥25)
• Low income family as determined by HHS Poverty Guidelines

Exclusion criteria

• Diagnosis of mental retardation, autism or other pervasive developmental disorder for child;
• Current serious psychiatric or medical disorder requiring immediate treatment, including active alcohol or substance use disorders (confirmed by urine toxicology screening and history), psychotic illnesses, suicidal ideation, untreated diabetes, cardiovascular disease, cancers or any other active current illnesses that preclude study participation for child or parent;
• Inadequate English proficiency to complete questionnaires.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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246 participants in 3 patient groups

Parenting Mindfully for Health Nutrition (PMH)

Experimental group

Description:

Parenting Mindfully for Health (PMH) + nutrition and physical activity counseling to promote healthy eating and physical activity in parent and child.

Treatment:

Behavioral: Parenting Mindfully for Health Nutrition (PMH)

Contact Control Nutrition (C+N)

Active Comparator group

Description:

Contact control intervention (C) + nutrition and physical activity counseling (N).

Treatment:

Behavioral: Contact Control Nutrition (C+N)

Historical Control (WLC) non-randomized

Other group

Description:

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

Treatment:

Other: Non-randomized historical control (WLC) assessment only