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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HG006073-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Human Genome Research Institute (NHGRI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No risk feedback | No Intervention | No obesity risk information given (control) | |
| Genetic risk feedback | Experimental | Only personal genetic risk information provided |
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| Lifestyle risk feedback | Experimental | Only personal lifestyle risk information provided |
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| Both genetic or lifestyle risk feedback | Experimental | Personal genetic and lifestyle information provided |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genetic | Genetic | Relative risk estimates will be presented based on individuals' risk for obesity based on FTO genotype results. |
|
| 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 |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Catharine Wang, PhD, MSc | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coriell Institute for Medical Research | Camden | New Jersey | 08103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27891830 | Background | 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. | |
| 24216219 | Derived | 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. |
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No plan to share data
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| ID | Title | Description |
|---|---|---|
| FG000 | No Risk Feedback | No risk feedback for obesity was provided. |
| FG001 | Genetic Risk Feedback | FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results. |
| FG002 | Lifestyle Risk Feedback | Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV). |
| FG003 | Both Genetic and Lifestyle Risk Feedback | FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results. Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Based on participants who completed the baseline survey
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| ID | Title | Description |
|---|---|---|
| BG000 | No Risk Feedback | No risk feedback for obesity was provided. |
| BG001 | Genetic Risk Feedback | FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months after viewing obesity risk assessment |
|
1 year, 11 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Risk Feedback | Control arm - no obesity risk feedback provided |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Catharine Wang | Boston University School of Public Health | 617-638-5187 | clwang@bu.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Lifestyle | Behavioral | Relative risk estimates will be presented based on individuals' risk for obesity due to lifestyle factors. |
|
|
| BG002 | Lifestyle Risk Feedback | Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV). |
| BG003 | Both Genetic and Lifestyle Risk Feedback | FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results. Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV). |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Lifestyle Risk Feedback |
Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV). |
| OG003 | Genetic and Lifestyle Risk Feedback | FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results. Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV). |
|
|
|
| Primary | 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). | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months after viewing obesity risk assessment |
|
|
|
|
| Primary | 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) | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months from viewing obesity risk assessment |
|
|
|
|
| 0 |
| 198 |
| 0 |
| 198 |
| EG001 | Genetic Risk Feedback | FTO variant: Relative risk estimates will be presented based on individuals'risk for obesity based on genotype results. | 0 | 203 | 0 | 203 |
| EG002 | Lifestyle Risk Feedback | Lifestyle: Relative risk estimates will be presented based on individuals' risk for obesity due to lifestyle factors. | 0 | 196 | 0 | 196 |
| EG003 | Both Genetic and Lifestyle Risk Feedback | FTO variant: Relative risk estimates will be presented based on individuals'risk for obesity based on genotype results. Lifestyle: Relative risk estimates will be presented based on individuals' risk for obesity due to lifestyle factors. | 0 | 201 | 0 | 201 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |