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

Childhood Obesity Clinical Trial

— ENRICH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02739334
• Other study ID #: HSC-MS-15-0293
• Status: Recruiting
• Phase: N/A
• First received: March 24, 2016
• Last updated: April 14, 2016
• Start date: March 2016

Study information

• Verified date: April 2016
• Source: The University of Texas Health Science Center, Houston
• Contact: Shreela Sharma, PhD, RD
• Phone: 713-500-9244
• Email: Shreela.v.sharma[@]uth.tmc.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Months to 48 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in child Body Mass Index		baseline and 10 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	change in daily minutes of physical activity for the child as assessed using accelerometers		baseline and 10 weeks	No