Expired Study
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Camden, New Jersey 08103


Purpose:

This study will examine the impact of providing genetic risk information for obesity on people's attitudes and beliefs about obesity, health behaviors and weight outcomes. Specifically, this study will examine the feasibility of using genetic information to motivate efforts to reduce obesity among individuals recruited to the Coriell Personalized Medicine Collaborative (CPMC), see below for description of CPMC.


Study summary:

The investigators will conduct a randomized controlled feasibility trial to examine the short-term impact of personalized risk feedback for obesity. This study is uniquely situated to provide important data on how individuals interpret various sources of risk information and how they arrive at an overall perception of risk for a condition. Taken altogether, study findings will be used to serve as an overall model for future intervention efforts to effectively communicate obesity risk information with the goal of improving weight management and overall population health. CPMC-The CPMC is an ongoing evidence-based longitudinal research study designed to determine the utility of using personal genome information in health management and clinical decision-making. They collect saliva samples, perform genetic analysis and provide genetic risk feedback for several disease conditions including coronary artery disease and type 2 diabetes. The present study will build upon the existing genetic testing and web feedback infrastructure at Coriell to conduct behavioral science research to address critical public health questions.


Criteria:

Inclusion Criteria: Must be age 18 or older, active enrollees in the CPMC trial, and able to read and write in English. Exclusion Criteria: Individuals that do not meet the inclusion criteria.


Study is Available At:


Original ID:

CW-R21


NCT ID:

NCT01355224


Secondary ID:

1R21HG006073-01


Study Acronym:


Brief Title:

Communicating Risk Information for Obesity


Official Title:

Communicating Genetic Information for Obesity


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Boston University


Oversight Authority:

  • United States: Federal Government
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

798


Enrollment Type:

Actual


Overall Contact Information

Official Name:Catharine Wang, PhD, MSc
Principal Investigator
Boston University

Study Dates

Start Date:September 2011
Completion Date:September 2013
Completion Type:Actual
Primary Completion Date:September 2013
Primary Completion Type:Actual
Verification Date:July 2014
Last Changed Date:July 17, 2014
First Received Date:May 4, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change from baseline behavioral and weight outcomes at 3 months
Time Frame:Baseline and 3 months from viewing obesity risk assessment
Safety Issues:False
Description:Lifestyle behavioral intentions, actual health behaviors, weight
Outcome Type:Secondary Outcome
Measure:Change from baseline causal attributions at 3 months
Time Frame:Baseline and 3 months from viewing obesity risk assessment
Safety Issues:False
Description:Beliefs about the causes of obesity
Outcome Type:Secondary Outcome
Measure:Change in baseline attitudes towards obese people at 3 months
Time Frame:Baseline and 3 months from viewing obesity risk assessment
Safety Issues:False
Description:Attitudes towards obese people will be assessed using the Fat Phobia Scale (Bacon, Scheltema, & Robinson, 2001). This semantic differential scale contains 14 items that assess attitudes about obese people. The scale lists 14 pairs of adjectives descri

Study Interventions

Intervention Type:Genetic
Name:FTO variant
Description:Relative risk estimates will be presented based on individuals'risk for obesity based on genotype results.
Arm Name:Genetic risk feedback
Other Name:Genetic risk
Intervention Type:Behavioral
Name:Lifestyle
Description:Relative risk estimates will be presented based on individuals' risk for obesity due to lifestyle factors.
Arm Name:Lifestyle risk feedback
Other Name:Lifestyle risk

Study Arms

Study Arm Type:Experimental
Arm Name:Both genetic or lifestyle risk feedback
Study Arm Type:Experimental
Arm Name:Lifestyle risk feedback
Study Arm Type:Experimental
Arm Name:Genetic risk feedback
Study Arm Type:No Intervention
Arm Name:No risk feedback

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Boston University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Human Genome Research Institute (NHGRI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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