Clinical trial NCT03950453: Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention
Official title: Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Child Obesity
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-05-15
Enrollment: 246
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cohort study
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Parent Stress change from Pre to Post intervention
timeFrame: Baseline Pre-intervention to Post intervention at 12 weeks
measure: Child BMI change post intervention and at short term 6 month follow-up
timeFrame: Change from Pre-intervention to post-intervention (week 12) and at 6 month short term follow up
measure: Child food intake change
timeFrame: Baseline Pre-intervention and at post-intervention (week 12)
measure: Parenting Behavior Change
timeFrame: TWT parenting behavior ratings at Baseline Pre-intervention and at post-intervention (week 12)
Secondary outcomes:
measure: Parent Stress change from Post intervention to follow up period over 24-months
timeFrame: Post intervention at 12 weeks to follow-up timepoints at 6-, 12-, 18- and 24- month timepoints
measure: Child BMI change at long term term follow-up
timeFrame: Baseline compared to 12-month, 18-month and 24-month timepoint
measure: Child food intake change
timeFrame: Baseline Pre-intervention and at post-intervention (week 12)
measure: Parenting Stress Inventory (PSI)
timeFrame: PSI scores at Baseline Pre-intervention and at post-intervention (week 12) and at follow-ups months 6-, 12-, 18- and 24 month timepoints
Other outcomes:
measure: Parent BMI
timeFrame: baseline
measure: Parent BMI
timeFrame: at 12 week timepoint
measure: Parent BMI
timeFrame: at 6 month timepoint
measure: Parent BMI
timeFrame: at 12 month timepoint
measure: Parent BMI
timeFrame: at 18 month timepoint
measure: Parent BMI
timeFrame: at 24 month timepoint
Locations:
city: New Haven
country: United States
facility: The Yale Stress Center: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Rajita Sinha
role: PRINCIPAL_INVESTIGATOR
References: