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

NCT ID: NCT02739334

Last Updated: 2016-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Childhood Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

ENRICH

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Control - monthly handouts

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

24 Months

Maximum Eligible Age

48 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Shreela V Sharma

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shreela Sharma, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Shreela Sharma, PhD, RD

Role: CONTACT

713-500-9244

Facility Contacts

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Shreela Sharma, PhD, RD

Role: primary

713-500-9344

Other Identifiers

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HSC-MS-15-0293

Identifier Type: -

Identifier Source: org_study_id

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