ObesityNCT01270763
Gene x Behavior Interaction in the Look AHEAD Study
An observational study of Obesity and Type 2 Diabetes, run by The Miriam Hospital at 1 site in United States.
Trial summary
The interplay of genetic and behavioral factors is critical to understanding obesity. Behavioral weight loss intervention has emerged as a key strategy in combating obesity. However, individuals differ in their degree of success in these programs and genetic factors are known to play a role. Read more about this study
- Who is it for?
- Ages 45 to 74 years
- Conditions the study is for
- Obesity, Type 2 Diabetes
- What is being tested?
- Intensive lifestyle intervention and Diabetes support and education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,108 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Mar 2015
- 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 45 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 5,145 individuals who are overweight or obese, have type 2 diabetes and are enrolled in the Look AHEAD Study
Who may be able to join
- Enrollment in the Look AHEAD Study, genetic consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The interplay of genetic and behavioral factors is critical to understanding obesity. Behavioral weight loss intervention has emerged as a key strategy in combating obesity. However, individuals differ in their degree of success in these programs and genetic factors are known to play a role. In this application, the investigators propose to identify specific genes that predict individual differences in weight loss and high density lipoprotein cholesterol in response to behavioral intervention to help identify individuals that struggle with weight loss and cholesterol despite behavioral efforts.
Read the detailed description
The interplay of genetic and behavioral factors is critical to understanding obesity. Obesity is a major public health problem, with millions of Americans suffering from weight-related health complications, including Type 2 diabetes, coronary heart disease, hypertension, and osteoarthritis. Behavioral weight loss intervention has emerged as a key strategy in combating obesity and the associated health consequences. However, individuals differ in their degree of success in these programs even if they make the recommended behavioral changes and genetic factors are known to play a role. In this application, the investigators propose to identify specific genes that predict individual differences in weight loss in response to behavioral intervention to help identify individuals who struggle with weight loss despite behavioral efforts. Specifically, the investigators will determine whether obesity genes interact with lifestyle intervention in predicting weight loss at year 1 of the Look AHEAD trial, an NIH-funded, multi-center randomized controlled trial with the primary goal of determining whether weight loss achieved through an intensive lifestyle intervention can reduce cardiovascular morbidity and mortality among persons with type 2 diabetes. At year 1, participants assigned to Intensive Lifestyle Intervention (ILI), focusing on changes in diet and physical activity, lost an average of 8.6% of their weight (N = 2,496; 97.1% follow-up) relative to losses of 0.7% among individuals assigned to the Diabetes Support and Education (DSE) group (N= 2,463, 95.7% follow-up), who received diabetes support and education groups alone. Consent for genetic analyses was provided by 3,759 participants. Genotype data from the IBC chip, a genotyping platform including 50,000 single nucleotide polymorphisms (SNPs) from ~2,600 genes relevant to cardiovascular disease, lipid metabolism, diabetes and obesity, will allow us to test the central hypothesis that genes that predispose to obesity interact with lifestyle treatment to influence weight loss following intensive lifestyle intervention. The investigators will also determine whether genes related to high density lipoprotein (HDL) cholesterol predict the degree of improvement in HDL in response to the behavioral intervention. The investigators conduct these aims with the explicit goal of bringing together a team with expertise in behavioral research, genetic epidemiology and molecular biology to create transdisciplinary researchers who are able to bridge across the disciplines and identify key gene x behavior interactions in the context of the Look AHEAD trial.
- Conditions
- Obesity, Type 2 Diabetes
- Being tested
- Intensive lifestyle intervention, Diabetes support and education
- Keywords
- Obesity, physical fitness, cholesterol levels, genetics, weight loss
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive lifestyle interventionBehavioural
Lifestyle intervention focused on weight loss through diet and physical activity
Diabetes support and educationBehavioural
Behavioral intervention focused on diabetes support and education
| Study group | Role | What they receive |
|---|---|---|
| The Look AHEAD Study | The Look AHEAD Study includes intensive lifestyle intervention treatment, focusing on caloric intake and physical activity, and a treatment arm focused on diabetes support and education. Receives: Behavioral: Intensive lifestyle intervention; Behavioral: Diabetes support and education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measured: 4 years
High density lipoprotein cholesterol
Measured: 4 years
Secondary outcomes (2)
Dietary intake
Measured: 4 years
Physical activity/fitness
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startJul 2009
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- 4,108 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts Medical Center, Brown University
- Responsible party
- Principal investigator, Jeanne McCaffery, The Miriam Hospital
- Investigators
- Jeanne McCaffery, Ph.D., Principal investigator, The Miriam HospitalRena Wing, Ph.D., Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270763
- Sponsor's protocol ID
- GxB in Look AHEAD
- Status last verified
- Mar 2015
- First submitted
- 12 Nov 2010
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Look AHEAD Research Group. Prospective Association of GLUL rs10911021 With Cardiovascular Morbidity and Mortality Among Individuals With Type 2 Diabetes: The Look AHEAD Study. Diabetes. 2016 Jan;65(1):297-302. doi: 10.2337/db15-0890. Epub 2015 Sep 22.
PubMed 26395743Look AHEAD Research Group. Prospective association of a genetic risk score and lifestyle intervention with cardiovascular morbidity and mortality among individuals with type 2 diabetes: the Look AHEAD randomised controlled trial. Diabetologia. 2015 Aug;58(8):1803-13. doi: 10.1007/s00125-015-3610-z. Epub 2015 May 14.
PubMed 25972230McCaffery JM, Papandonatos GD, Huggins GS, Peter I, Erar B, Kahn SE, Knowler WC, Lipkin EW, Kitabchi AE, Wagenknecht LE, Wing RR; Genetic Subgroup of Look AHEAD; Look AHEAD Research Group. Human cardiovascular disease IBC chip-wide association with weight loss and weight regain in the look AHEAD trial. Hum Hered. 2013;75(2-4):160-74. doi: 10.1159/000353181. Epub 2013 Sep 27.
PubMed 24081232McCaffery JM, Papandonatos GD, Peter I, Huggins GS, Raynor HA, Delahanty LM, Cheskin LJ, Balasubramanyam A, Wagenknecht LE, Wing RR; Genetic Subgroup of Look AHEAD; Look AHEAD Research Group. Obesity susceptibility loci and dietary intake in the Look AHEAD Trial. Am J Clin Nutr. 2012 Jun;95(6):1477-86. doi: 10.3945/ajcn.111.026955. Epub 2012 Apr 18.
PubMed 22513296
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene x Behavior Interaction in the Look AHEAD Study
- ClinicalTrials.gov ID
- NCT01270763
- Acronym / sponsor ID
- GxB in Look AHEAD
- Conditions
- Obesity, Type 2 Diabetes
- Keywords
- Obesity, physical fitness, cholesterol levels, genetics, weight loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,108 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- Tufts Medical Center, Brown University
- Study start
- Jul 2009
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 5 Jan 2011 (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.
The interplay of genetic and behavioral factors is critical to understanding obesity. Behavioral weight loss intervention has emerged as a key strategy in combating obesity. However, individuals differ in their degree of success in these programs and genetic factors are known to play a role. In this application, the investigators propose to identify specific genes that predict individual differences in weight loss and high density lipoprotein cholesterol in response to behavioral intervention to help identify individuals that struggle with weight loss and cholesterol despite behavioral efforts.
Detailed description
The interplay of genetic and behavioral factors is critical to understanding obesity. Obesity is a major public health problem, with millions of Americans suffering from weight-related health complications, including Type 2 diabetes, coronary heart disease, hypertension, and osteoarthritis. Behavioral weight loss intervention has emerged as a key strategy in combating obesity and the associated health consequences. However, individuals differ in their degree of success in these programs even if they make the recommended behavioral changes and genetic factors are known to play a role. In this application, the investigators propose to identify specific genes that predict individual differences in weight loss in response to behavioral intervention to help identify individuals who struggle with weight loss despite behavioral efforts. Specifically, the investigators will determine whether obesity genes interact with lifestyle intervention in predicting weight loss at year 1 of the Look AHEAD trial, an NIH-funded, multi-center randomized controlled trial with the primary goal of determining whether weight loss achieved through an intensive lifestyle intervention can reduce cardiovascular morbidity and mortality among persons with type 2 diabetes. At year 1, participants assigned to Intensive Lifestyle Intervention (ILI), focusing on changes in diet and physical activity, lost an average of 8.6% of their weight (N = 2,496; 97.1% follow-up) relative to losses of 0.7% among individuals assigned to the Diabetes Support and Education (DSE) group (N= 2,463, 95.7% follow-up), who received diabetes support and education groups alone. Consent for genetic analyses was provided by 3,759 participants. Genotype data from the IBC chip, a genotyping platform including 50,000 single nucleotide polymorphisms (SNPs) from ~2,600 genes relevant to cardiovascular disease, lipid metabolism, diabetes and obesity, will allow us to test the central hypothesis that genes that predispose to obesity interact with lifestyle treatment to influence weight loss following intensive lifestyle intervention. The investigators will also determine whether genes related to high density lipoprotein (HDL) cholesterol predict the degree of improvement in HDL in response to the behavioral intervention. The investigators conduct these aims with the explicit goal of bringing together a team with expertise in behavioral research, genetic epidemiology and molecular biology to create transdisciplinary researchers who are able to bridge across the disciplines and identify key gene x behavior interactions in the context of the Look AHEAD trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Look AHEAD Study | – | Behavioral: Intensive lifestyle intervention, Behavioral: Diabetes support and educationThe Look AHEAD Study includes intensive lifestyle intervention treatment, focusing on caloric intake and physical activity, and a treatment arm focused on diabetes support and education. |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 5,145 individuals who are overweight or obese, have type 2 diabetes and are enrolled in the Look AHEAD Study
Key inclusion criteria (1 listed)
- Enrollment in the Look AHEAD Study, genetic consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Intensive lifestyle interventionLifestyle intervention focused on weight loss through diet and physical activity | Behavioural | The Look AHEAD Study |
| Diabetes support and educationBehavioral intervention focused on diabetes support and education | Behavioural | The Look AHEAD Study |
Primary outcome
Body weight
Time frame: 4 years
High density lipoprotein cholesterol
Time frame: 4 years
2 secondary outcomes
Dietary intake
Time frame: 4 years
Physical activity/fitness
Time frame: 4 years
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 18 Mar 2015.
- Derived from this study: PubMed 26395743Look AHEAD Research Group. Prospective Association of GLUL rs10911021 With Cardiovascular Morbidity and Mortality Among Individuals With Type 2 Diabetes: The Look AHEAD Study. Diabetes. 2016 Jan;65(1):297-302. doi: 10.2337/db15-0890. Epub 2015 Sep 22.
- Derived from this study: PubMed 25972230Look AHEAD Research Group. Prospective association of a genetic risk score and lifestyle intervention with cardiovascular morbidity and mortality among individuals with type 2 diabetes: the Look AHEAD randomised controlled trial. Diabetologia. 2015 Aug;58(8):1803-13. doi: 10.1007/s00125-015-3610-z. Epub 2015 May 14.
- Derived from this study: PubMed 24081232McCaffery JM, Papandonatos GD, Huggins GS, Peter I, Erar B, Kahn SE, Knowler WC, Lipkin EW, Kitabchi AE, Wagenknecht LE, Wing RR; Genetic Subgroup of Look AHEAD; Look AHEAD Research Group. Human cardiovascular disease IBC chip-wide association with weight loss and weight regain in the look AHEAD trial. Hum Hered. 2013;75(2-4):160-74. doi: 10.1159/000353181. Epub 2013 Sep 27.
- Derived from this study: PubMed 22513296McCaffery JM, Papandonatos GD, Peter I, Huggins GS, Raynor HA, Delahanty LM, Cheskin LJ, Balasubramanyam A, Wagenknecht LE, Wing RR; Genetic Subgroup of Look AHEAD; Look AHEAD Research Group. Obesity susceptibility loci and dietary intake in the Look AHEAD Trial. Am J Clin Nutr. 2012 Jun;95(6):1477-86. doi: 10.3945/ajcn.111.026955. Epub 2012 Apr 18.
Related trials for Obesity
Recruiting
Preserving Muscle Mass During Incretin-Induced Weight Loss
Obesity (BMI > 35)
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Synchronous vs Asynchronous Remotely Delivered Lifestyle Interventions
Obesity
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.
Jeanne McCaffery, Ph.D. principal investigator
The Miriam Hospital
Rena Wing, Ph.D. principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Type 2 Diabetes, run by The Miriam Hospital at 1 site 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 1 inclusion and 0 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 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Body weight (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01270763, which also lists 4 linked publications.
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 18 Mar 2015.