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

Primary Purpose

Childhood Obesity

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ENRICH

Control - monthly handouts

About this trial

This is an interventional treatment trial for Childhood Obesity

Eligibility Criteria

24 Months - 48 Months (Child)All SexesDoes not accept 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

Sites / Locations

University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ENRICH

Control - monthly handouts

Arm 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.

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.

Outcomes

Primary Outcome Measures

change in child Body Mass Index

Secondary Outcome Measures

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.

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.

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

Full Information

NCT ID

NCT02739334

First Posted

March 24, 2016

Last Updated

April 14, 2016

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT02739334

Brief Title

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

Acronym

ENRICH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Unknown status

Study Start Date

March 2016 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Childhood Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ENRICH

Arm Type

Experimental

Arm Description

Arm Title

Control - monthly handouts

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

ENRICH

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Control - monthly handouts

Intervention Description

Primary Outcome Measure Information:

Title

change in child Body Mass Index

Time Frame

baseline and 10 weeks

Secondary Outcome Measure Information:

Title

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

Description

investigators will assess intake of sugar sweetened beverages per day as collected using multiple 24 hour recalls with the parents conducted by trained interviewers.

Time Frame

baseline and 10 weeks

Title

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

Description

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.

Time Frame

baseline and 10 weeks

Title

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

Time Frame

baseline and 10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

24 Months

Maximum Age & Unit of Time

48 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shreela Sharma, PhD, RD

Phone

713-500-9244

Shreela.v.sharma@uth.tmc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shreela Sharma, PhD, RD

Organizational Affiliation

The University of Texas Health Science Center, Houston

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Health Science Center at Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shreela Sharma, PhD, RD

Phone

713-500-9344

Shreela.V.Sharma@uth.tmc.edu

12. IPD Sharing Statement

Learn more about this trial

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

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