Obesity
Conditions
Keywords
obesity, genetics, risk assessment, health behaviors, randomized controlled trial
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.
Interventions
GENETICGenetic
Relative risk estimates will be presented based on individuals' risk for obesity based on FTO genotype results.
BEHAVIORALLifestyle
Relative risk estimates will be presented based on individuals' risk for obesity due to lifestyle factors.
Sponsors
National Human Genome Research Institute (NHGRI)
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intentions to Lose Weight - Effect of Study Arm on Outcomes | 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. |
| Intention to Lose Weight - Impact of Risk Status | 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). |
| Intention to Lose Weight - Combined Risk | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Risk Feedback No risk feedback for obesity was provided. | 167 |
| Genetic Risk Feedback FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results. | 180 |
| 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). | 177 |
| 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). | 172 |
| Total | 696 |
Baseline characteristics
| Characteristic | Total | No Risk Feedback | Genetic Risk Feedback | Lifestyle Risk Feedback | Both Genetic and Lifestyle Risk Feedback |
|---|---|---|---|---|---|
| Age, Continuous | 50 years | 51 years | 51 years | 51 years | 48 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 2 Participants | 3 Participants | 7 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 678 Participants | 163 Participants | 176 Participants | 170 Participants | 169 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 5 Participants | 1 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 2 Participants | 5 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 18 Participants | 2 Participants | 6 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 3 Participants | 2 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 636 Participants | 155 Participants | 166 Participants | 161 Participants | 154 Participants |
| Sex: Female, Male Female | 472 Participants | 111 Participants | 121 Participants | 118 Participants | 122 Participants |
| Sex: Female, Male Male | 224 Participants | 56 Participants | 59 Participants | 59 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 198 | 0 / 203 | 0 / 196 | 0 / 201 |
| serious Total, serious adverse events | 0 / 198 | 0 / 203 | 0 / 196 | 0 / 201 |
Outcome results
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.
Time frame: 3 months after viewing obesity risk assessment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Risk Feedback | Intentions to Lose Weight - Effect of Study Arm on Outcomes | 3.06 units on a scale |
| Genetic Risk Feedback | Intentions to Lose Weight - Effect of Study Arm on Outcomes | 3.37 units on a scale |
| Lifestyle Risk Feedback | Intentions to Lose Weight - Effect of Study Arm on Outcomes | 3.26 units on a scale |
| Genetic and Lifestyle Risk Feedback | Intentions to Lose Weight - Effect of Study Arm on Outcomes | 3.26 units on a scale |
p-value: 0.015Regression, Linear
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)
Time frame: 3 months from viewing obesity risk assessment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Risk Feedback | Intention to Lose Weight - Combined Risk | 3.08 units on a scale |
| Genetic Risk Feedback | Intention to Lose Weight - Combined Risk | 3.38 units on a scale |
| Lifestyle Risk Feedback | Intention to Lose Weight - Combined Risk | 3.12 units on a scale |
| Genetic and Lifestyle Risk Feedback | Intention to Lose Weight - Combined Risk | 3.24 units on a scale |
| High Lifestyle Risk Feedback | Intention to Lose Weight - Combined Risk | 3.37 units on a scale |
p-value: 0.0622Regression, Linear
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).
Time frame: 3 months after viewing obesity risk assessment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Risk Feedback | Intention to Lose Weight - Impact of Risk Status | 3.05 units on a scale |
| Genetic Risk Feedback | Intention to Lose Weight - Impact of Risk Status | 3.38 units on a scale |
| Lifestyle Risk Feedback | Intention to Lose Weight - Impact of Risk Status | 3.35 units on a scale |
| Genetic and Lifestyle Risk Feedback | Intention to Lose Weight - Impact of Risk Status | 3.38 units on a scale |
| High Lifestyle Risk Feedback | Intention to Lose Weight - Impact of Risk Status | 3.19 units on a scale |
p-value: 0.0365Regression, Linear