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Communicating Risk Information for Obesity

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ClinicalTrials.gov Identifier: NCT01355224
Recruitment Status : Completed
First Posted : May 18, 2011
Results First Posted : March 14, 2017
Last Update Posted : March 14, 2017
Sponsor:
Collaborator:
National Human Genome Research Institute (NHGRI)
Information provided by (Responsible Party):
Catharine Wang, Boston University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Obesity
Interventions Genetic: Genetic
Behavioral: Lifestyle
Enrollment 798
Recruitment Details  
Pre-assignment Details  
Arm/Group Title No Risk Feedback Genetic Risk Feedback Lifestyle Risk Feedback Both Genetic and Lifestyle Risk Feedback
Hide Arm/Group Description No risk feedback for obesity was provided. 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).

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).

Period Title: Overall Study
Started 198 203 196 201
Competed Baseline 191 200 193 193
Completed 167 180 177 172
Not Completed 31 23 19 29
Arm/Group Title No Risk Feedback Genetic Risk Feedback Lifestyle Risk Feedback Both Genetic and Lifestyle Risk Feedback Total
Hide Arm/Group Description No risk feedback for obesity was provided. 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).

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 of all reporting groups
Overall Number of Baseline Participants 167 180 177 172 696
Hide Baseline Analysis Population Description
Based on participants who completed the baseline survey
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 167 participants 180 participants 177 participants 172 participants 696 participants
51
(21 to 82)
51
(20 to 77)
51
(21 to 81)
48
(20 to 81)
50
(20 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants 180 participants 177 participants 172 participants 696 participants
Female
111
  66.5%
121
  67.2%
118
  66.7%
122
  70.9%
472
  67.8%
Male
56
  33.5%
59
  32.8%
59
  33.3%
50
  29.1%
224
  32.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants 180 participants 177 participants 172 participants 696 participants
Hispanic or Latino
2
   1.2%
3
   1.7%
7
   4.0%
3
   1.7%
15
   2.2%
Not Hispanic or Latino
163
  97.6%
176
  97.8%
170
  96.0%
169
  98.3%
678
  97.4%
Unknown or Not Reported
2
   1.2%
1
   0.6%
0
   0.0%
0
   0.0%
3
   0.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants 180 participants 177 participants 172 participants 696 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
   3.0%
1
   0.6%
1
   0.6%
6
   3.5%
13
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   1.2%
5
   2.8%
4
   2.3%
5
   2.9%
16
   2.3%
White
155
  92.8%
166
  92.2%
161
  91.0%
154
  89.5%
636
  91.4%
More than one race
2
   1.2%
6
   3.3%
7
   4.0%
3
   1.7%
18
   2.6%
Unknown or Not Reported
3
   1.8%
2
   1.1%
4
   2.3%
4
   2.3%
13
   1.9%
1.Primary Outcome
Title Intentions to Lose Weight - Effect of Study Arm on Outcomes
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Risk Feedback Genetic Risk Feedback Lifestyle Risk Feedback Genetic and Lifestyle Risk Feedback
Hide Arm/Group Description:
Control - no obesity risk feedback provided.
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).

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 Number of Participants Analyzed 167 180 177 172
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
3.06
(2.93 to 3.19)
3.37
(2.24 to 3.50)
3.26
(3.13 to 3.39)
3.26
(3.13 to 3.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Risk Feedback, Genetic Risk Feedback, Lifestyle Risk Feedback, Genetic and Lifestyle Risk Feedback
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0150
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for age, gender, BMI, baseline intention.
2.Primary Outcome
Title Intention to Lose Weight - Impact of Risk Status
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Risk Feedback Low Genetic Risk Feedback High Genetic Risk Feedback Low Lifestyle Risk Feedback High Lifestyle Risk Feedback
Hide Arm/Group Description:
Control - no obesity risk feedback provided.
Genetic feedback arm; did not have elevated risk for obesity based on FTO alone.
Genetic feedback arm; had elevated risk for obesity based on FTO alone.
Lifestyle feedback arm; did not have elevated risk for obesity based on lifestyle behavior alone.
Lifestyle feedback arm; had elevated risk for obesity based on lifestyle behavior alone.
Overall Number of Participants Analyzed 167 69 111 54 123
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
3.05
(2.91 to 3.19)
3.38
(3.17 to 3.59)
3.35
(3.18 to 3.52)
3.38
(3.15 to 3.61)
3.19
(3.03 to 3.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Risk Feedback, Low Genetic Risk Feedback, High Genetic Risk Feedback, Low Lifestyle Risk Feedback, High Lifestyle Risk Feedback
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0365
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for age, gender, BMI, and baseline intent.
3.Primary Outcome
Title Intention to Lose Weight - Combined Risk
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Risk Feedback Low Genetic Risk + Low Lifestyle Risk Feedback Low Genetic Risk + High Lifestyle Risk Feedback High Genetic Risk + Low Lifestyle Risk Feedback High Genetic Risk + High Lifestyle Risk Feedback
Hide Arm/Group Description:
Control - no obesity risk feedback provided.
Feedback received: Did not have elevated risk for obesity based on FTO; did not have elevated risk for obesity based on lifestyle behavior.
Feedback received: Did not have elevated risk for obesity based on FTO; had elevated risk for obesity based on lifestyle behavior.
Feedback received: Had elevated risk for obesity based on FTO; did not have elevated risk for obesity based on lifestyle behavior.
Feedback received: Had elevated risk for obesity based on FTO; Had elevated risk for obesity based on lifestyle behavior.
Overall Number of Participants Analyzed 167 20 43 33 76
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
3.08
(2.96 to 3.21)
3.38
(3.03 to 3.72)
3.12
(2.88 to 3.36)
3.24
(2.97 to 3.51)
3.37
(3.19 to 3.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection No Risk Feedback, Low Genetic Risk + Low Lifestyle Risk Feedback, Low Genetic Risk + High Lifestyle Risk Feedback, High Genetic Risk + Low Lifestyle Risk Feedback, High Genetic Risk + High Lifestyle Risk Feedback
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0622
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for age, gender, BMI, and baseline intent.
Time Frame 1 year, 11 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title No Risk Feedback Genetic Risk Feedback Lifestyle Risk Feedback Both Genetic and Lifestyle Risk Feedback
Hide Arm/Group Description Control arm - no obesity risk feedback provided 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.

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.

All-Cause Mortality
No Risk Feedback Genetic Risk Feedback Lifestyle Risk Feedback Both Genetic and Lifestyle Risk Feedback
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
No Risk Feedback Genetic Risk Feedback Lifestyle Risk Feedback Both Genetic and Lifestyle Risk Feedback
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/198 (0.00%)   0/203 (0.00%)   0/196 (0.00%)   0/201 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
No Risk Feedback Genetic Risk Feedback Lifestyle Risk Feedback Both Genetic and Lifestyle Risk Feedback
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/198 (0.00%)   0/203 (0.00%)   0/196 (0.00%)   0/201 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Catharine Wang
Organization: Boston University School of Public Health
Phone: 617-638-5187
EMail: clwang@bu.edu
Responsible Party: Catharine Wang, Boston University
ClinicalTrials.gov Identifier: NCT01355224     History of Changes
Other Study ID Numbers: CW-R21
1R21HG006073-01 ( U.S. NIH Grant/Contract )
First Submitted: May 4, 2011
First Posted: May 18, 2011
Results First Submitted: August 8, 2016
Results First Posted: March 14, 2017
Last Update Posted: March 14, 2017