Gene x Behavior Interaction in the Look AHEAD Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by The Miriam Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Tufts Medical Center
Brown University
Information provided by:
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01270763
First received: November 12, 2010
Last updated: January 4, 2011
Last verified: November 2010
  Purpose

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.


Condition Intervention
Obesity
Diabetes Mellitus, Type 2
Behavioral: Intensive lifestyle intervention
Behavioral: Diabetes support and education

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gene x Behavior Interaction in the Look AHEAD Study

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Body weight [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • High density lipoprotein cholesterol [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dietary intake [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Physical activity/fitness [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

DNA obtained as part of the parent study


Enrollment: 4108
Study Start Date: July 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Behavioral: Intensive lifestyle intervention
Lifestyle intervention focused on weight loss through diet and physical activity
Behavioral: Diabetes support and education
Behavioral intervention focused on diabetes support and education

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.

  Eligibility

Ages Eligible for Study:   45 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

5,145 individuals who are overweight or obese, have type 2 diabetes and are enrolled in the Look AHEAD Study

Criteria

Inclusion Criteria:

  • Enrollment in the Look AHEAD Study, genetic consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01270763

Locations
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Miriam Hospital
Tufts Medical Center
Brown University
Investigators
Principal Investigator: Jeanne McCaffery, Ph.D. The Miriam Hospital
Principal Investigator: Rena Wing, Ph.D. The Miriam Hospital
  More Information

No publications provided by The Miriam Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeanne McCaffery (Associate Professor, Weight Control and Diabetes Research Center), The Miriam Hospital and the School of Medicine at Brown University
ClinicalTrials.gov Identifier: NCT01270763     History of Changes
Other Study ID Numbers: GxB in Look AHEAD
Study First Received: November 12, 2010
Last Updated: January 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by The Miriam Hospital:
Obesity
physical fitness
cholesterol levels
genetics
weight loss

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014