Community-based Program to Treat Childhood Obesity

NCT ID: NCT01374646

Last Updated: 2021-06-23

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

COMPLETED

Clinical Phase

NA

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-01

Study Completion Date

2012-06-05

Brief Summary

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This study will evaluate the effectiveness of a comprehensive community based program on reducing excess weight in children and teens. This study will recruit 150 participants between the ages of 6-12 and 13-17.

Detailed Description

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This study will evaluate the effectiveness of a comprehensive community based program on reducing excess weight. Overweight and obese study participants will be grouped with peers of similar ages and their parent/guardians. The participants will be divided into 2 groups, child (6-12 yrs. old) and teens (13-17 yrs. old) and will be accompanied by their parent/guardian. 150 participants will be recruited for this study.

This 6-month program (12 in-person group workshop sessions and 12 at-home sessions) takes the best components of current evidence for individual treatment and places them in a comprehensive community based program. These include:

* Parental involvement
* Reduction in consumption of sugar sweetened beverages
* Reduction of screen time
* Self-monitoring
* Physical activity
* Stimulus control

Conditions

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Childhood Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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JOIN Intervention

Behavioral group treatment for overweight and obese children and teens, that focuses on decreasing energy dense foods and sedentary behaviors.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Children and teens between the ages of 6-17
* BMI percentile ≥85
* Participation of a parent/guardian

Exclusion Criteria

* Enrollment in another weight loss program or study
* Diagnosis of type 1 or type 2 diabetes
* Pre-existing medical conditions (e.g., Prader Willi) that affect weight and appetite
* Medications (e.g., steroids) that affect weight or appetite
* Serious or unstable medical or psychological conditions that, in the opinion of the Principal Investigator, would compromise the participant's safety or successful participation in the study
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UnitedHealth Group

INDUSTRY

Sponsor Role lead

Responsible Party

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UnitedHealth Group

Principal Investigators

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Deneen Votja, MD

Role: PRINCIPAL_INVESTIGATOR

UnitedHealth Group

Locations

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YMCA of Greater Providence

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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JOIN2011 10-309

Identifier Type: -

Identifier Source: org_study_id

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