Exercise ResponseTIGERNCT01127919
Training Interventions and Genetics of Exercise Response (TIGER)
An observational study of Exercise Response, run by Molly S. Bray at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Response
- What is being tested?
- Aerobic Exercise Training and Cognitive Component
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3,773 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2010to Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 18-30 years old
- Healthy
- sedentary at baseline
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Houston
Houston, Texas, 77005
About this study
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.
Read the 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.
- Conditions
- Exercise Response
- Being tested
- Aerobic Exercise Training, Cognitive Component
- Keywords
- Exercise, Activity, Adherence, Genetics
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise TrainingBehavioural
40 minutes, 3 times a week for 35 weeks.
Cognitive ComponentOther
Provide general information about health and fitness
| Study group | Role | What they receive |
|---|---|---|
| Low Commitment | Group 1 participants will take a 1-credit hour course that involves exercise training only. Receives: 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 Receives: Behavioral: Aerobic Exercise Training; Other: 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. Receives: Other: Cognitive Component |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Response
Physiologic variables measured pre and post exercise intervention
Measured: 15 Weeks
Gene Expression
Changes in the expression of genes following exercise training
Measured: 15 Weeks
Adherence
Retention versus drop-out from the exercise protocol
Measured: 15 Weeks
Genotyping
Characterization of candidate genes related to exercise response
Measured: 15 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startJul 2010
- Primary completionMay 2016
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,773 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molly S. Bray
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Molly S. Bray, University of Texas at Austin
- Investigators
- Molly Bray, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127919
- Sponsor's protocol ID
- R01DK062148
- Other IDs
- R01DK062148
- Acronym
- TIGER
- Status last verified
- Nov 2017
- First submitted
- 19 May 2010
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Interventions and Genetics of Exercise Response (TIGER)
- ClinicalTrials.gov ID
- NCT01127919
- Acronym / sponsor ID
- TIGER / R01DK062148
- Conditions
- Exercise Response
- Keywords
- Exercise, Activity, Adherence, Genetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,773 participants (actual)
- Lead sponsor
- Molly S. BrayUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2010
- Primary completion
- May 2016 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 21 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Commitment | – | Behavioral: Aerobic Exercise TrainingGroup 1 participants will take a 1-credit hour course that involves exercise training only. |
| High Commitment | – | Behavioral: Aerobic Exercise Training, Other: Cognitive ComponentGroup 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 |
| Non-Exercise | – | Other: Cognitive ComponentGroup 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 18-30 years old
- Healthy
- sedentary at baseline
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise Training40 minutes, 3 times a week for 35 weeks. | Behavioural | High Commitment, Low Commitment |
| Cognitive ComponentProvide general information about health and fitness | Other | High Commitment, Non-Exercise |
Primary outcome
Exercise Response
Time frame: 15 Weeks
Physiologic variables measured pre and post exercise intervention
Gene Expression
Time frame: 15 Weeks
Changes in the expression of genes following exercise training
Adherence
Time frame: 15 Weeks
Retention versus drop-out from the exercise protocol
Genotyping
Time frame: 15 Weeks
Characterization of candidate genes related to exercise response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Molly Bray, PhD principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exercise Response, run by Molly S. Bray at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Response (time frame: 15 Weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2017.