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

NCT02739334 | Unknown

• 1 other identifier: HSC-MS-15-0293
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• change in child Body Mass Index

  baseline and 10 weeks

Secondary Outcomes (3)

• change in intake of servings of sugar sweetened beverages for the child as assessed using 24 hour parent-reported recalls

  baseline and 10 weeks

• change in total intake of servings fruits and vegetables for the child as assessed using 24 hour parent-reported recalls

  baseline and 10 weeks

• change in daily minutes of physical activity for the child as assessed using accelerometers

  baseline and 10 weeks

Study Arms (2)

ENRICH

EXPERIMENTAL

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

Control - monthly handouts

ACTIVE COMPARATOR

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

Interventions

ENRICH BEHAVIORAL

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.

ENRICH

Control - monthly handouts BEHAVIORAL

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.

Control - monthly handouts

Eligibility Criteria

• Age: 24 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shreela Sharma, PhD, RD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shreela Sharma, PhD, RD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: April 15, 2016
• Study Start: March 1, 2016
• Primary Completion: June 1, 2017
• Last Updated: April 15, 2016

Record last verified: 2016-04

Locations

US (1)