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Completed

NCT Number: NCT01355224

Communicating Risk 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.

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Key information

Conditions

Obesity Behavior Body Weight Health Behavior Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coriell Institute for Medical Research

Camden, New Jersey, 08103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Lifestyle

Behavioral

Relative risk estimates will be presented based on individuals' risk for obesity due to lifestyle factors.

Other names: Lifestyle risk, Lifestyle risk feedback

Primary outcomes

  1. 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.

  2. 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. 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)

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • National Human Genome Research Institute (NHGRI)

Registry information

Official study title

Communicating Genetic Information for Obesity

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 18, 2011
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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