Genetic Counseling and Lifestyle Change for Diabetes Prevention

Massachusetts General Hospital90 enrolled

Overview

This study will examine the impact diabetes genetic counseling on patient motivation and disease prevention behaviors among subjects with pre-diabetes. Intervention subjects will be provided with their individual diabetes genotype risk score derived from aggregating the combined results of 37 diabetes risk-associated genetic loci. Controls will not be tested. All subjects will be enrolled in a 12-week diabetes prevention program.

This study will examine the impact diabetes genetic counseling on patient motivation and disease prevention behaviors among subjects with pre-diabetes. We will randomize subjects with pre-diabetes to genetic testing vs. no genetic testing in order to obtain an unconfounded test of the hypothesis that genetic testing will change patient behavior. Intervention subjects will be provided with their individual diabetes genotype risk score derived from aggregating the combined results of 37 diabetes risk-associated genetic loci. Because patients can receive either "Higher risk" or "Lower risk" genetic test results, we will separately examine the impact of "Higher risk" and "Lower risk" test results compared to untested controls. All subjects will be enrolled in a 12-week diabetes prevention program.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Pre-diabetes Overweight Metabolic Syndrome

Interventions

Diabetes Genetic CounselingBEHAVIORAL

Subjects will be genotyped based on a 37-allele aggregate score and counseled regarding the implications of the results prior to enrollment in a 12-week diabetes prevention program

No genetic counselingBEHAVIORAL

These subjects will not be genotyped or counseled prior to enrollment in a 12-week diabetes prevention program

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Overweight (Body mass index ≥ 29.1 kg/m2 in men, ≥ 27.2 kg/m2 in women) with at least 2 other formal criteria for Metabolic Syndrome (see Table -NCEP ATP-III Criteria) * Adult (\> 21 years of age) * No diagnosis or treatment for diabetes (Type 1 or Type 2) or cardiovascular disease (e.g. myocardial infraction, coronary bypass surgery, congestive heart failure, peripheral vascular disease) * Physically able and willing to participate in a 12-week group session curriculum for weight loss and dietary change * Able to understand and communicate effectively in English

Locations (1)

Massachusetts General Hospital Practice Based Research Network

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

stage of change

Time frame: baseline, after counseling, after completing program (3 months)

Secondary Outcomes

program attendance

Time frame: 3 months

Data from ClinicalTrials.gov

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