Communicating Risk Information for Obesity
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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 |
- 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
- 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:
|
| Experimental: Lifestyle risk feedback |
Behavioral: Lifestyle
Relative risk estimates will be presented based on individuals' risk for obesity due to lifestyle factors.
Other Names:
|
| 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:
Behavioral: Lifestyle
Relative risk estimates will be presented based on individuals' risk for obesity due to lifestyle factors.
Other Names:
|
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 |
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| Contact: Lisa Wawak | 856-757-4845 | lwawak@coriell.org |
| 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 | |
| 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 May 23, 2013