Training Interventions and Genetics of Exercise Response (TIGER) (TIGER)

November 8, 2017 updated by: Molly S. Bray
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Among the greatest public health concerns today is the rapid rise in obesity in the pediatric population, which now exceeds 18% in children (6-11 y) and 17% in adolescents (12-19 y), while obesity among young adults (20-39 y) approaches 30%. Though much has been learned regarding the regulation of body weight and the development of adiposity, the prevalence of obesity continues to rise, demonstrating that even today the factors that predict healthy weight maintenance remain poorly understood. In fact, the transition from overweight adolescent to obese adult is almost inevitable, with the probability of obesity in adulthood exceeding 50% among children >13 years of age whose BMI percentiles meet or exceed the 95th percentile for age and gender. But what if we could deter the expected transition from overweight adolescent to obese adult and intervene on a young person at a critical time when he/she is beginning to feel empowered by independence? This is the essence of the Training Interventions and Genetics of Exercise Response (TIGER) Study. The TIGER Study began in 2003 with the goal of identifying genetic factors that influence physiologic response to exercise training, while introducing sedentary college age individuals to regular exercise. Subjects in the TIGER Study currently underwent 30 weeks (2 semesters) of exercise training, 3 days per week for 40 minutes at 65-85% of age-predicted maximum heart rate. More than 80% of subjects lost weight or maintained their weight within 2 kg, and only 18% of subjects gained more than 2 kg. We have identified preliminary associations between gene variation and exercise dropout in the first phase of the study, and in phase 2 of the TIGER study, we will build on these observations. We will focus on three primary areas of investigation: 1) formal evaluation of the TIGER Study intervention protocol to achieve long-term change in the participants; 2) investigation of gene expression patterns in skeletal muscle and subcutaneous adipose tissue as a strategy for identifying genes related to exercise response; and 3) investigation of the association between genetic variation and exercise adherence. Subjects will undergo 35 weeks of exercise training based on the established TIGER protocol, and subjects will be re-contacted 6, 12, and 24 months following completion of the study protocol and questioned regarding current exercise habits and body weight. In addition, genetic analysis of candidate genes related to exercise behavior and neural signaling will be undertaken in order to identify genetic factors that may influence exercise adherence. Finally, patterns of gene expression in subcutaneous adipose, skeletal muscle, and peripheral leukocytes will be analyzed at baseline and following exercise training in order to identify factors that influence physiologic change consequent to exercise training. Results from this study are designed to enlighten our current understanding of how and why individuals respond and/or persist in exercise, with the ultimate goal of formulating better and more efficacious interventions for obesity.

Study Type

Observational

Enrollment (Actual)

3773

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Texas
      • Houston, Texas, United States, 77005
        • University of Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 18-30 years old
  • Healthy
  • sedentary at baseline

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Low Commitment
Group 1 participants will take a 1-credit hour course that involves exercise training only.
Behavioral: Aerobic Exercise Training
40 minutes, 3 times a week for 35 weeks.
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 Training
40 minutes, 3 times a week for 35 weeks.
Other: Cognitive Component
Provide general information about health and fitness
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
Provide general information about health and fitness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Response
Time Frame: 15 Weeks
Physiologic variables measured pre and post exercise intervention
15 Weeks
Gene Expression
Time Frame: 15 Weeks
Changes in the expression of genes following exercise training
15 Weeks
Adherence
Time Frame: 15 Weeks
Retention versus drop-out from the exercise protocol
15 Weeks
Genotyping
Time Frame: 15 Weeks
Characterization of candidate genes related to exercise response
15 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Molly S. Bray

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Molly Bray, PhD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

May 19, 2010

First Submitted That Met QC Criteria

May 20, 2010

First Posted (Estimate)

May 21, 2010

Study Record Updates

Last Update Posted (Actual)

November 13, 2017

Last Update Submitted That Met QC Criteria

November 8, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R01DK062148 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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