NCT01681108

Brief Summary

The purpose of this study is to verify the usefulness of Healthy KIDS Program (HKP) for children and adolescents to lose weight and promote their self esteem in a fun atmosphere.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jun 2006

Longer than P75 for not_applicable obesity

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
9 months until next milestone

First Posted

Study publicly available on registry

September 7, 2012

Completed
Last Updated

September 7, 2012

Status Verified

September 1, 2012

Enrollment Period

5.5 years

First QC Date

March 28, 2011

Last Update Submit

September 6, 2012

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • BMI will be measured

    Data will be collected at routine office visits

    3 month interval over 1 year

Secondary Outcomes (2)

  • Weight

    3 month interval over 1 year

  • Height

    3 month interval over 1 year

Study Arms (1)

Lifestyle counseling

OTHER

Individualized meal planning and exercise regimen sessions will be developed for each participant

Behavioral: Lifestyle counseling

Interventions

Lifestyle counselingBEHAVIORAL

Individualized meal planning and exercise regimen sessions will be developed for each participant

Lifestyle counseling

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children and adolescents between the ages of 8 and 16 years with a BMI \> 85th%.

You may not qualify if:

  • Children younger then 8 years of age or older then 16 years of age.
  • Children with a BMI \< 85th%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Siham Accacha, MD

    Winthrop University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2011

First Posted

September 7, 2012

Study Start

June 1, 2006

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

September 7, 2012

Record last verified: 2012-09

Locations

US(1)