Clinical trial NCT01355224: Communicating Risk Information for Obesity
Official title: Communicating Genetic Information for Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
genetics
risk assessment
health behaviors
randomized controlled trial
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Human Genome Research Institute (NHGRI)
First posted: 2011-05-18
Enrollment: 798
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.

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 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.

Primary outcomes:
measure: Intentions to Lose Weight - Effect of Study Arm on Outcomes
timeFrame: 3 months after viewing obesity risk assessment
measure: Intention to Lose Weight - Impact of Risk Status
timeFrame: 3 months after viewing obesity risk assessment
measure: Intention to Lose Weight - Combined Risk
timeFrame: 3 months from viewing obesity risk assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Camden
country: United States
facility: Coriell Institute for Medical Research
state: New Jersey
Study officials:
affiliation: Boston University
name: Catharine Wang, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang C, Gordon ES, Norkunas T, Wawak L, Liu CT, Winter M, Kasper RS, Christman MF, Green RC, Bowen DJ. A randomized trial Examining The Impact Of Communicating Genetic And Lifestyle Risks For Obesity. Obesity (Silver Spring). 2016 Dec;24(12):2481-2490. doi: 10.1002/oby.21661.
citation: Wang C, Gordon ES, Stack CB, Liu CT, Norkunas T, Wawak L, Christman MF, Green RC, Bowen DJ. A randomized trial of the clinical utility of genetic testing for obesity: design and implementation considerations. Clin Trials. 2014 Feb;11(1):102-13. doi: 10.1177/1740774513508029. Epub 2013 Nov 11.