NCT00562263

Brief Summary

The current study aims to investigate the impact of a comprehensive, team-based, family-centered, lifestyle modification program on body weight, metabolic abnormalities, fitness measures, and self-esteem in overweight adolescents beginning the study at ages 11-18 years. The intensive program will uniquely include a "team" structure and a component designed to address the role of parental modeling in effective lifestyle changes. By comparing the demographic, psychosocial, and metabolic characteristics of adolescents according to the degree of weight loss, the study will also more fully characterize the barriers that prevent successful participation in an intensive lifestyle modification program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
257

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable

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

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2007

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

March 31, 2014

Status Verified

March 1, 2014

Enrollment Period

6.1 years

First QC Date

November 20, 2007

Last Update Submit

March 28, 2014

Conditions

Overweight

Keywords

overweightobesityadolescentinsulin resistancetreatment

Outcome Measures

Primary Outcomes (1)

  • changes in BMI Z-score

    3 month, 6 month, 12 months and 24 months

Secondary Outcomes (1)

  • Changes in body composition, metabolic and anthropometric measures, fitness measures, dietary intake, and quality of life scores.

    3 month, 6 month, 1 year and 2 years.

Study Arms (2)

Lifestyle Modification

EXPERIMENTAL

Parents are randomized to attend 12 educational sessions covering strategies to manage children's health behaviors.

Behavioral: Lifestyle modification

Control

NO INTERVENTION

Teen participates in lifestyle intervention, but parent does not attend parent education sessions

Interventions

Lifestyle modificationBEHAVIORAL

Dietary modification and regular physical activity

Also known as: Weight Loss, Wellness
Lifestyle Modification

Eligibility Criteria

Age11 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age between 11 and 18
  • BMI at or above the 85th percentile for age and sex
  • At least one adult in the household who is committed to come to the program meetings

You may not qualify if:

  • Previous enrollment in VCU IRB 3354
  • Underlying genetic, neurologic, endocrine, or metabolic conditions that preclude weight loss with conventional diet and exercise programs
  • Weight greater than 400 pounds
  • Pregnancy in female adolescent subjects
  • Inability to understand program instructions due to language barrier or a mental disability
  • Primary residence outside a 30 mile radius program facility.
  • Primary participating parent, if female, cannot be pregnant during the period corresponding to the parents intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • Ning Y, Yang S, Evans RK, Stern M, Sun S, Francis GL, Wickham EP 3rd. Changes in body anthropometry and composition in obese adolescents in a lifestyle intervention program. Eur J Nutr. 2014 Jun;53(4):1093-102. doi: 10.1007/s00394-013-0612-9. Epub 2013 Nov 10.

    PMID: 24212451DERIVED

MeSH Terms

Conditions

OverweightObesityInsulin Resistance

Interventions

Health

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • Gary L. Francis, M.D.

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2007

First Posted

November 22, 2007

Study Start

October 1, 2007

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

March 31, 2014

Record last verified: 2014-03

Locations

US(1)