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

Not Applicable

• Conditions: Childhood Obesity
• Interventions: Behavioral: Control - monthly handouts; Behavioral: ENRICH

• Registration Number: NCT02739334
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-24
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-14
• Last Update Submitted: 2016-04-14
• Study First Posted: 2016-04-15
• Last Update Posted: 2016-04-15
• Primary Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control - monthly handouts	Control - monthly handouts	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.
ENRICH	ENRICH	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.

Primary Outcome Measures

Name	Time	Method
change in child Body Mass Index	baseline and 10 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States