NCT01127919

Brief Summary

Obesity established in adolescence strongly predicts obesity for the remainder of adult life, and the consequences are potentially devastating, characterized by a lifelong burden of co-morbid conditions and depression. This study will provide an exposure to physical activity that is designed to teach and empower sedentary college age individuals to become physically active. The investigators will evaluate whether such exposure can result in lasting changes in exercise behavior and body composition. The study will also provide a better understanding of the genetic factors that influence persistence in an exercise program and that influence whole body response to exercise training. Altering the course of obesity in adolescence has the potential to reduce the adult prevalence of obesity and consequently attenuate the public health burden of overweight and obesity in the investigators population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,773

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

May 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

5.8 years

First QC Date

May 19, 2010

Last Update Submit

November 8, 2017

Conditions

Keywords

ExerciseActivityAdherenceGenetics

Outcome Measures

Primary Outcomes (4)

  • Exercise Response

    Physiologic variables measured pre and post exercise intervention

    15 Weeks

  • Gene Expression

    Changes in the expression of genes following exercise training

    15 Weeks

  • Adherence

    Retention versus drop-out from the exercise protocol

    15 Weeks

  • Genotyping

    Characterization of candidate genes related to exercise response

    15 Weeks

Study Arms (3)

Low Commitment

Group 1 participants will take a 1-credit hour course that involves exercise training only.

Behavioral: Aerobic Exercise Training

High Commitment

Group 2 participants will take a 3-credit hour course that involves exercise training plus an online cognitive component that provides information on fitness and health topics and includes quizzes and other written course work

Behavioral: Aerobic Exercise TrainingOther: Cognitive Component

Non-Exercise

Group 3 participants will take the cognitive component of the formal course but will not partake in the formalized exercise program for a period of 35 weeks.

Other: Cognitive Component

Interventions

40 minutes, 3 times a week for 35 weeks.

High CommitmentLow Commitment

Provide general information about health and fitness

High CommitmentNon-Exercise

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The target for phase 2 of the TIGER study is a student, age 18-30, who has not engaged in moderate physical activity more than 30 minutes per week for the previous 30 days and who is not actively limiting his/her caloric intake by dieting. It is planned to enroll a total of 3,200 subjects from student populations at the University of Houston (UH) and the University of Alabama at Birmingham (UAB) and representative of the race/ethnicity distribution of the respective campuses. Approximately 2,400 subjects will participate in the exercise protocol (600/yr for four years). A control group (200/yr for four years) will also be recruited that will not participate in the formal exercise for at least 35 weeks, but will be given the option of completing the formal exercise program after that time.

You may qualify if:

  • years old
  • Healthy
  • sedentary at baseline

You may not qualify if:

  • any medical or physical contra-indication for exercise (as indicated by the subject's physician) and/or
  • any known metabolic or endocrine disorder associated with alterations in body composition (e.g., lipodystrophy).
  • Refusal to consent for the use of their DNA for genetic research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Houston

Houston, Texas, 77005, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood components and DNA

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Molly Bray, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Public Health

Study Record Dates

First Submitted

May 19, 2010

First Posted

May 21, 2010

Study Start

July 1, 2010

Primary Completion

May 1, 2016

Study Completion

November 1, 2017

Last Updated

November 13, 2017

Record last verified: 2017-11

Locations