Recruiting

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

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT02739334

Conditions

Childhood Obesity

Eligibility Criteria

Sex: All

Age: 2 - 4

Healthy Volunteers: Not accepted

Interventions

ENRICH

Control - monthly handouts

Study Details

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.

Conditions

Childhood Obesity

Study ID

NCT02739334

Start date

Mar, 2016

Status verified date

Apr, 2016

Primary completion date

Jun, 2017

Anticipated

Eligibility Criteria

Sex: All

Age: 2 - 4

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

ENRICH

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.

Control - monthly handouts

Primary outcome measure

change in child Body Mass Index [ Time Frame: baseline and 10 weeks ]

Central Contacts and Locations

Central contacts

Shreela Sharma, PhD, RD

713-500-9244 Shreela.v.sharma@uth.tmc.edu

Locations

University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Shreela Sharma, PhD, RD

713-500-9344 Shreela.V.Sharma@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Apr 15, 2016

Last verified

Apr, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2016-04-15.