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Training Interventions and Genetics of Exercise Response (TIGER)

NCT ID: NCT01127919

Last Updated: 2017-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3773 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2017-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Exercise Response

Keywords

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Exercise Activity Adherence Genetics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Low Commitment

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

Aerobic Exercise Training

Intervention Type BEHAVIORAL

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

Aerobic Exercise Training

Intervention Type BEHAVIORAL

40 minutes, 3 times a week for 35 weeks.

Cognitive Component

Intervention Type OTHER

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.

Cognitive Component

Intervention Type OTHER

Provide general information about health and fitness

Interventions

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Aerobic Exercise Training

40 minutes, 3 times a week for 35 weeks.

Intervention Type BEHAVIORAL

Cognitive Component

Provide general information about health and fitness

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

Molly S. Bray

OTHER

Sponsor Role lead

Responsible Party

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Molly S. Bray

Professor of Public Health

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Molly Bray, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of Houston

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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R01DK062148

Identifier Type: NIH

Identifier Source: secondary_id

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R01DK062148

Identifier Type: NIH

Identifier Source: org_study_id

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