Identification of Predictors of Success for Lifestyle Modifications in Overweight Pre-diabetic Subjects

M

Marie-France Langlois

Status

Completed

Conditions

Obesity
Glucose Intolerance

Treatments

Behavioral: Lifestyle modification counselling

Study type

Interventional

Funder types

Other

Identifiers

NCT00969007
08-083

Details and patient eligibility

About

The primary objective of the study is to identify baseline and early predictors of favorable and unfavorable response to lifestyle intervention. As a secondary objective, the investigators would like to validate our questionnaire or other identified predictors as clinical tools to guide us in selection of the most suitable candidates for lifestyle intervention programs. Assuming the same capacity of our questionnaire to predict an absence of weight loss (≥5%) or a loss to follow-up (likelihood ratio for a positive test, LR+ = 9.9), 70 subjects need to be included in this study in order to find a lower limit of the 95% confidence interval above 2.0 for this LR+, which is the limit of an acceptable test. The investigators will enroll participants with pre-diabetes and BMI 27-40 in our program and administer to them at baseline and at 3 months the designed questionnaire, as well as other already well validated questionnaires assessing state of change and readiness to implement diet or exercise modifications.

Enrollment

81 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • BMI between 27-40 kg/m2
  • impaired glucose tolerance, confirmed by an oral glucose tolerance test (OGTT = fasting glucose lower than 7.0 mmol/l and glucose 2 hours post 75g of glucose between 7.8-11.0 mmol/l), or impaired fasting glucose (6.1-6.9 mmol/L)
  • 18 years old or more
  • Being able to read and give an informed consent

Exclusion criteria

Conditions that affects weight or glucose metabolism

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

81 participants in 1 patient group

Lifestyle counseling
Experimental group
Treatment:
Behavioral: Lifestyle modification counselling

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems