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Communicating Risk Information for Obesity

This study has been completed.
Sponsor:
Collaborator:
National Human Genome Research Institute (NHGRI)
Information provided by (Responsible Party):
Catharine Wang, Boston University
ClinicalTrials.gov Identifier:
NCT01355224
First received: May 4, 2011
Last updated: January 24, 2017
Last verified: January 2017
  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: Genetic
Behavioral: Lifestyle

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Participant, Investigator
Primary Purpose: Prevention
Official Title: Communicating Genetic Information for Obesity

Further study details as provided by Boston University:

Primary Outcome Measures:
  • 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.

  • 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).

  • 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)


Enrollment: 798
Study Start Date: September 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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: NCT01355224

Locations
United States, New Jersey
Coriell Institute for Medical Research
Camden, New Jersey, United States, 08103
Sponsors and Collaborators
Boston University
National Human Genome Research Institute (NHGRI)
Investigators
Principal Investigator: Catharine Wang, PhD, MSc Boston University
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Catharine Wang, Associate Professor, Boston University
ClinicalTrials.gov Identifier: NCT01355224     History of Changes
Other Study ID Numbers: CW-R21
1R21HG006073-01 ( US NIH Grant/Contract Award Number )
Study First Received: May 4, 2011
Results First Received: August 8, 2016
Last Updated: January 24, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: No plan to share data

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 28, 2017