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

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.

Study Overview

• Status: Unknown
• Conditions: Childhood Obesity
• Intervention / Treatment: Behavioral: ENRICH; Behavioral: Control - monthly handouts

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shreela Sharma, PhD, RD; Phone Number: 713-500-9244; Email: Shreela.v.sharma@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas Health Science Center at Houston
      • Contact: Shreela Sharma, PhD, RD; Phone Number: 713-500-9344; Email: Shreela.V.Sharma@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.
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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Shreela Sharma, PhD, RD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: March 24, 2016
• First Submitted That Met QC Criteria: April 14, 2016
• First Posted (Estimate): April 15, 2016

Study Record Updates

• Last Update Posted (Estimate): April 15, 2016
• Last Update Submitted That Met QC Criteria: April 14, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: HSC-MS-15-0293