NCT01270763

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,108

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 5, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

5.7 years

First QC Date

November 12, 2010

Last Update Submit

March 17, 2015

Conditions

ObesityType 2 Diabetes

Keywords

Obesityphysical fitnesscholesterol levelsgeneticsweight loss

Outcome Measures

Primary Outcomes (2)

  • Body weight

    4 years

  • High density lipoprotein cholesterol

    4 years

Secondary Outcomes (2)

  • Dietary intake

    4 years

  • Physical activity/fitness

    4 years

Study Arms (1)

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 interventionBehavioral: Diabetes support and education

Interventions

Intensive lifestyle interventionBEHAVIORAL

Lifestyle intervention focused on weight loss through diet and physical activity

The Look AHEAD Study
Diabetes support and educationBEHAVIORAL

Behavioral intervention focused on diabetes support and education

The Look AHEAD Study

Eligibility Criteria

Age45 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Enrollment in the Look AHEAD Study, genetic consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (4)

  • 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.

    PMID: 26395743DERIVED

  • Look 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.

    PMID: 25972230DERIVED

  • McCaffery 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.

    PMID: 24081232DERIVED

  • McCaffery 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.

    PMID: 22513296DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA obtained as part of the parent study

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Weight Loss

Interventions

Educational Status

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBody Weight Changes

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Jeanne McCaffery, Ph.D.

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

  • Rena Wing, Ph.D.

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist/Associate Professor

Study Record Dates

First Submitted

November 12, 2010

First Posted

January 5, 2011

Study Start

July 1, 2009

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 18, 2015

Record last verified: 2015-03

Locations

US(1)