NCT01374646

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2012

Completed
Last Updated

June 23, 2021

Status Verified

June 1, 2021

Enrollment Period

1.4 years

First QC Date

June 14, 2011

Last Update Submit

June 21, 2021

Conditions

Childhood Obesity

Keywords

Childhood ObesityGroup TreatmentCommunity-based Programs

Outcome Measures

Primary Outcomes (1)

  • Change in weight and body mass index (BMI) in children and teens at 6 months

    Assess the effects of a community based program on weight change in children ages 6-12 and teens ages 13-17. Assessments will occur at baseline, 3 and 6 months.

    6 Months

Secondary Outcomes (4)

  • Change in weight and BMI in parent/guardian/care giver at 6 months

    6 months

  • Change in physical activity level in children and teens at 6 months

    6 months

  • Changes in intake and sedentary behavior at 6 months

    6 months

  • Process Outcomes

    6 Months

Interventions

JOIN InterventionBEHAVIORAL

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

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

YMCA of Greater Providence

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Deneen Votja, MD

    UnitedHealth Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 14, 2011

First Posted

June 16, 2011

Study Start

January 1, 2011

Primary Completion

June 5, 2012

Study Completion

June 5, 2012

Last Updated

June 23, 2021

Record last verified: 2021-06

Locations

US(1)