Trial Outcomes & Findings for Communicating Risk Information for Obesity (NCT NCT01355224)
NCT ID: NCT01355224
Last Updated: 2017-03-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
798 participants
Primary outcome timeframe
3 months after viewing obesity risk assessment
Results posted on
2017-03-14
Participant Flow
Participant milestones
| Measure |
No Risk Feedback
No risk feedback for obesity was provided.
|
Genetic Risk Feedback
FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.
|
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).
|
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).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
198
|
203
|
196
|
201
|
|
Overall Study
Competed Baseline
|
191
|
200
|
193
|
193
|
|
Overall Study
COMPLETED
|
167
|
180
|
177
|
172
|
|
Overall Study
NOT COMPLETED
|
31
|
23
|
19
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Communicating Risk Information for Obesity
Baseline characteristics by cohort
| Measure |
No Risk Feedback
n=167 Participants
No risk feedback for obesity was provided.
|
Genetic Risk Feedback
n=180 Participants
FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.
|
Lifestyle Risk Feedback
n=177 Participants
Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV).
|
Both Genetic and Lifestyle Risk Feedback
n=172 Participants
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).
|
Total
n=696 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51 years
n=39 Participants
|
51 years
n=41 Participants
|
51 years
n=35 Participants
|
48 years
n=31 Participants
|
50 years
n=146 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=39 Participants
|
121 Participants
n=41 Participants
|
118 Participants
n=35 Participants
|
122 Participants
n=31 Participants
|
472 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=39 Participants
|
59 Participants
n=41 Participants
|
59 Participants
n=35 Participants
|
50 Participants
n=31 Participants
|
224 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
15 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
163 Participants
n=39 Participants
|
176 Participants
n=41 Participants
|
170 Participants
n=35 Participants
|
169 Participants
n=31 Participants
|
678 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
13 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
16 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
155 Participants
n=39 Participants
|
166 Participants
n=41 Participants
|
161 Participants
n=35 Participants
|
154 Participants
n=31 Participants
|
636 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
18 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
13 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: 3 months after viewing obesity risk assessmentIntention 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.
Outcome measures
| Measure |
No Risk Feedback
n=167 Participants
Control - no obesity risk feedback provided.
|
Genetic Risk Feedback
n=180 Participants
FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.
|
Lifestyle Risk Feedback
n=177 Participants
Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV).
|
Genetic and Lifestyle Risk Feedback
n=172 Participants
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).
|
High Lifestyle Risk Feedback
Lifestyle feedback arm; had elevated risk for obesity based on lifestyle behavior alone.
|
|---|---|---|---|---|---|
|
Intentions to Lose Weight - Effect of Study Arm on Outcomes
|
3.06 units on a scale
Interval 2.93 to 3.19
|
3.37 units on a scale
Interval 2.24 to 3.5
|
3.26 units on a scale
Interval 3.13 to 3.39
|
3.26 units on a scale
Interval 3.13 to 3.39
|
—
|
PRIMARY outcome
Timeframe: 3 months after viewing obesity risk assessmentIntention 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).
Outcome measures
| Measure |
No Risk Feedback
n=167 Participants
Control - no obesity risk feedback provided.
|
Genetic Risk Feedback
n=69 Participants
FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.
|
Lifestyle Risk Feedback
n=111 Participants
Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV).
|
Genetic and Lifestyle Risk Feedback
n=54 Participants
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).
|
High Lifestyle Risk Feedback
n=123 Participants
Lifestyle feedback arm; had elevated risk for obesity based on lifestyle behavior alone.
|
|---|---|---|---|---|---|
|
Intention to Lose Weight - Impact of Risk Status
|
3.05 units on a scale
Interval 2.91 to 3.19
|
3.38 units on a scale
Interval 3.17 to 3.59
|
3.35 units on a scale
Interval 3.18 to 3.52
|
3.38 units on a scale
Interval 3.15 to 3.61
|
3.19 units on a scale
Interval 3.03 to 3.36
|
PRIMARY outcome
Timeframe: 3 months from viewing obesity risk assessmentIntention 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)
Outcome measures
| Measure |
No Risk Feedback
n=167 Participants
Control - no obesity risk feedback provided.
|
Genetic Risk Feedback
n=20 Participants
FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.
|
Lifestyle Risk Feedback
n=43 Participants
Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV).
|
Genetic and Lifestyle Risk Feedback
n=33 Participants
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).
|
High Lifestyle Risk Feedback
n=76 Participants
Lifestyle feedback arm; had elevated risk for obesity based on lifestyle behavior alone.
|
|---|---|---|---|---|---|
|
Intention to Lose Weight - Combined Risk
|
3.08 units on a scale
Interval 2.96 to 3.21
|
3.38 units on a scale
Interval 3.03 to 3.72
|
3.12 units on a scale
Interval 2.88 to 3.36
|
3.24 units on a scale
Interval 2.97 to 3.51
|
3.37 units on a scale
Interval 3.19 to 3.56
|
Adverse Events
No Risk Feedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Genetic Risk Feedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lifestyle Risk Feedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Both Genetic and Lifestyle Risk Feedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Catharine Wang
Boston University School of Public Health
Phone: 617-638-5187
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place