Communicating Risk Information for Obesity

January 24, 2017 updated by: Catharine Wang, Boston University

Communicating Genetic Information for Obesity

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

798

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Coriell Institute for Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No risk feedback
No obesity risk information given (control)
Experimental: Genetic risk feedback
Only personal genetic risk information provided
Genetic: Genetic
Relative risk estimates will be presented based on individuals' risk for obesity based on FTO genotype results.
Other Names:
  • Genetic risk
  • Genetic risk feedback
  • FTO gene risk status
Experimental: Lifestyle risk feedback
Only personal lifestyle risk information provided
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
Personal genetic and lifestyle information provided
Genetic: Genetic
Relative risk estimates will be presented based on individuals' risk for obesity based on FTO genotype results.
Other Names:
  • Genetic risk
  • Genetic risk feedback
  • FTO gene risk status
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intentions to Lose Weight - Effect of Study Arm on Outcomes
Time Frame: 3 months after viewing obesity risk assessment
Intention to lose 10lbs in the next 6 months was measured on a 5-point likert scale (1-strongly disagree;5-strongly agree). Responses were examined by study arm.
3 months after viewing obesity risk assessment
Intention to Lose Weight - Impact of Risk Status
Time Frame: 3 months after viewing obesity risk assessment
Intention to lose 10lbs in the next 6 months measured on a 5-point likert scale (1-strongly disagree;5-strongly agree). This was examined by study arm and level of feedback received (high or elevated risk vs low or non-elevated risk).
3 months after viewing obesity risk assessment
Intention to Lose Weight - Combined Risk
Time Frame: 3 months from viewing obesity risk assessment
Intention to lose 10lbs in the next 6 months on a 5-point likert scale (1-strongly disagree; 5-strongly agree). This was examined by study arm and by combined levels of feedback (e.g. elevated genetic risk and non-elevated lifestyle risk)
3 months from viewing obesity risk assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University

Collaborators

National Human Genome Research Institute (NHGRI)

Investigators

  • Principal Investigator: Catharine Wang, PhD, MSc, Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

May 4, 2011

First Submitted That Met QC Criteria

May 16, 2011

First Posted (Estimate)

May 18, 2011

Study Record Updates

Last Update Posted (Actual)

March 14, 2017

Last Update Submitted That Met QC Criteria

January 24, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CW-R21
  • 1R21HG006073-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share data

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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