PALS-CATCH Intervention for Obesity Prevention Among At-risk Toddlers

Study Overview
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Brief Summary
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The purpose of this study is to learn whether a combination of two research-proven programs, a responsive caregiving parenting program and a childhood obesity prevention program, will have an effect on toddlers' healthy nutrition and physical activity behaviors. Investigators hypothesize that the children participating in the intervention will have significantly lower BMI z-scores, lower intake of sugar sweetened beverages, and increased number of servings of fruits and vegetables, and minutes of physical activity.

Official Title
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PALS-CATCH Intervention for Obesity Prevention Among At-risk Toddlers

Conditions
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Childhood Obesity

Intervention / Treatment
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* Behavioral: ENRICH
* Behavioral: Control - monthly handouts


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: child is 2 - 3 years at the time of enrollment child is >85th percentile for BMI ability of the parents to speak and read in English at the 4th grade level provide primarily in-home care for the children at the time of enrollment child is Medicaid eligible Exclusion Criteria: acute secondary complications of obesity for child (e.g., severe respiratory insufficiency) child with endocrine abnormalities child with severe obesity (>99.5th BMI percentile) children who have participated in an obesity treatment program within the past year parent with significant sensory impairments (e.g. deaf, blind) parent with BMI >40.0

Ages Eligible for Study
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Minimum Age: 24 Months
Maximum Age: 48 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ENRICH<br>The intervention will integrate the Play and Learning Strategies (PALS) program, a 10-week home-based parent-centered curriculum designed to facilitate parents' mastery of skills for interacting with their toddler with Coordinated Approach To Child Health (CATCH), a behaviorally-based school health promotion program based on Social Cognitive Theory (SCT) to increase opportunities for healthy eating and activity. | Behavioral: ENRICH<br>* The intervention, called ENRICH (Encouraging Nurturing Responsiveness to Improve Child Health), is a 10-week home-based parent-centered curriculum designed to facilitate parents' mastery of skills for interacting with their toddler to increase opportunities for healthy eating and activity. Each weekly session is a 60 minute session implemented by a trained coach.<br>|
| Active Comparator: Control - monthly handouts<br>The control group receives monthly handouts (one per month) for 3 months that provides information on various topics including child cognitive and language development and child behaviors as it pertains to 2 and 3 year old children. | Behavioral: Control - monthly handouts<br>* The control group receives monthly handouts (one per month) for 3 months that provides information on various topics including child cognitive and language development and child behaviors as it pertains to 2 and 3 year old children.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in child Body Mass Index |  | baseline and 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in intake of servings of sugar sweetened beverages for the child as assessed using 24 hour parent-reported recalls | investigators will assess intake of sugar sweetened beverages per day as collected using multiple 24 hour recalls with the parents conducted by trained interviewers. | baseline and 10 weeks | 
| change in total intake of servings fruits and vegetables for the child as assessed using 24 hour parent-reported recalls | investigators will assess total intake of servings of fruit and vegetable per day as collected using multiple 24 hour recalls with the parents conducted by trained interviewers. | baseline and 10 weeks | 
| change in daily minutes of physical activity for the child as assessed using accelerometers |  | baseline and 10 weeks |