PALS-CATCH Intervention for Obesity Prevention Among At-risk Toddlers (ENRICH)

The University of Texas System (UT)

Status: Unknown

Conditions: Childhood Obesity

Treatments: Behavioral: ENRICH; Behavioral: Control - monthly handouts

Study type: Interventional

Funder types: Other

Identifiers

NCT02739334

HSC-MS-15-0293

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 24 to 48 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

ENRICH

Experimental group

Description:

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.

Treatment:

Behavioral: ENRICH

Control - monthly handouts

Active Comparator group

Description:

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.

Treatment:

Behavioral: Control - monthly handouts