NCT01355224

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
798

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 18, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

March 14, 2017

Completed
Last Updated

March 14, 2017

Status Verified

January 1, 2017

Enrollment Period

2 years

First QC Date

May 4, 2011

Results QC Date

August 8, 2016

Last Update Submit

January 24, 2017

Conditions

Obesity

Keywords

obesitygeneticsrisk assessmenthealth behaviorsrandomized controlled trial

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (4)

No risk feedback

NO INTERVENTION

No obesity risk information given (control)

Genetic risk feedback

EXPERIMENTAL

Only personal genetic risk information provided

Genetic: Genetic

Lifestyle risk feedback

EXPERIMENTAL

Only personal lifestyle risk information provided

Behavioral: Lifestyle

Both genetic or lifestyle risk feedback

EXPERIMENTAL

Personal genetic and lifestyle information provided

Genetic: GeneticBehavioral: Lifestyle

Interventions

GeneticGENETIC

Relative risk estimates will be presented based on individuals' risk for obesity based on FTO genotype results.

Also known as: Genetic risk, Genetic risk feedback, FTO gene risk status
Both genetic or lifestyle risk feedbackGenetic risk feedback
LifestyleBEHAVIORAL

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

Also known as: Lifestyle risk, Lifestyle risk feedback
Both genetic or lifestyle risk feedbackLifestyle risk feedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be age 18 or older, active enrollees in the CPMC trial, and able to read and write in English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coriell Institute for Medical Research

Camden, New Jersey, 08103, United States

Location

Related Publications (2)

  • 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.

    PMID: 27891830BACKGROUND

  • 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.

    PMID: 24216219DERIVED

MeSH Terms

Conditions

ObesityHealth Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Results Point of Contact

Title
Dr. Catharine Wang
Organization
Boston University School of Public Health
clwang@bu.edu
617-638-5187

Study Officials

  • Catharine Wang, PhD, MSc

    Boston University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 4, 2011

First Posted

May 18, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

March 14, 2017

Results First Posted

March 14, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

No plan to share data

Locations

US(1)