Communicating Risk Information for Obesity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Boston University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT01355224
First received: May 4, 2011
Last updated: June 8, 2011
Last verified: June 2011
  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.


Condition Intervention
Obesity
Genetic: FTO variant
Behavioral: Lifestyle

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Communicating Genetic Information for Obesity

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Change from baseline behavioral and weight outcomes at 3 months [ Time Frame: Baseline and 3 months from viewing obesity risk assessment ] [ Designated as safety issue: No ]
    Lifestyle behavioral intentions, actual health behaviors, weight


Secondary Outcome Measures:
  • Change from baseline causal attributions at 3 months [ Time Frame: Baseline and 3 months from viewing obesity risk assessment ] [ Designated as safety issue: No ]
    Beliefs about the causes of obesity

  • Change in baseline attitudes towards obese people at 3 months [ Time Frame: Baseline and 3 months from viewing obesity risk assessment ] [ Designated as safety issue: No ]
    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 describing obese people (e.g., ''active'' vs. ''inactive,'') placed at opposite ends of a 5-point scale.


Estimated Enrollment: 1200
Study Start Date: September 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No risk feedback
Experimental: Genetic risk feedback Genetic: FTO variant
Relative risk estimates will be presented based on individuals'risk for obesity based on genotype results.
Other Names:
  • Genetic risk
  • Genetic risk feedback
Experimental: Lifestyle risk feedback Behavioral: Lifestyle
Relative risk estimates will be presented based on individuals' risk for obesity due to lifestyle factors.
Other Names:
  • Lifestyle risk
  • Lifestyle risk feedback
Experimental: Both genetic or lifestyle risk feedback Genetic: FTO variant
Relative risk estimates will be presented based on individuals'risk for obesity based on genotype results.
Other Names:
  • Genetic risk
  • Genetic risk feedback
Behavioral: Lifestyle
Relative risk estimates will be presented based on individuals' risk for obesity due to lifestyle factors.
Other Names:
  • Lifestyle risk
  • Lifestyle risk feedback

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01355224

Contacts
Contact: Lisa Wawak 856-757-4845 lwawak@coriell.org

Locations
United States, New Jersey
Coriell Institute for Medical Research Not yet recruiting
Camden, New Jersey, United States, 08103
Contact: Erynn Gordon       egordon@coriell.org   
Principal Investigator: Erynn Gordon, MS         
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Catharine Wang, PhD, MSc Boston University
  More Information

No publications provided

Responsible Party: Catharine Wang, PhD, MSc, Boston University, BUMC
ClinicalTrials.gov Identifier: NCT01355224     History of Changes
Other Study ID Numbers: CW-R21, 1R21HG006073-01
Study First Received: May 4, 2011
Last Updated: June 8, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Boston University:
obesity
genetics
risk assessment
health behaviors
randomized controlled trial

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014