Communicating Risk Information for Obesity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Communicating Genetic Information for Obesity

Conditions
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Obesity

Intervention / Treatment
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* Genetic: Genetic
* Behavioral: Lifestyle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No risk feedback<br>No obesity risk information given (control) | |
| Experimental: Genetic risk feedback<br>Only personal genetic risk information provided | Genetic: Genetic<br>* Relative risk estimates will be presented based on individuals' risk for obesity based on FTO genotype results.<br>* Other names: FTO gene risk status;|
| Experimental: Lifestyle risk feedback<br>Only personal lifestyle risk information provided | Behavioral: Lifestyle<br>* Relative risk estimates will be presented based on individuals' risk for obesity due to lifestyle factors.<br>* Other names: Lifestyle risk feedback;|
| Experimental: Both genetic or lifestyle risk feedback<br>Personal genetic and lifestyle information provided | Genetic: Genetic<br>* Relative risk estimates will be presented based on individuals' risk for obesity based on FTO genotype results.<br>* Other names: FTO gene risk status;Behavioral: Lifestyle<br>* Relative risk estimates will be presented based on individuals' risk for obesity due to lifestyle factors.<br>* Other names: Lifestyle risk feedback;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intentions to Lose Weight - Effect of Study Arm on Outcomes | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, genetics, risk assessment, health behaviors, randomized controlled trial