Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Pre Diabetes
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 64 years
Gender
Both males and females

Description

The Pre-DICTED program is designed as a randomized, controlled, pragmatic trial. The program targets to recruit up to 846 overweight/obese (BMI ?23.0) adults (age 18-64) with isolated impaired fasting glucose (IFG), isolated impaired glucose tolerance (IGT), or IFG + IGT in Singapore. The follow-up ...

The Pre-DICTED program is designed as a randomized, controlled, pragmatic trial. The program targets to recruit up to 846 overweight/obese (BMI ?23.0) adults (age 18-64) with isolated impaired fasting glucose (IFG), isolated impaired glucose tolerance (IGT), or IFG + IGT in Singapore. The follow-up period will be 3 years. Eligible subjects will be identified through community, primary care clinics and hospital-based diabetes screening program. Following informed consent, eligible participants will be randomised into the control or the treatment arm. Participants in the control arm will receive the current standard of care for pre-diabetes which includes counseling on lifestyle modifications and follow up by primary care physicians. Participants in the treatment arm will undergo a 3-month, locally tailored, group-based lifestyle intervention program (consisting of nutrition workshops, exercise sessions and goal-setting workshop) plus subsequent stepwise addition of metformin for selected participants at the highest risk of progression to diabetes at ? 6 months of follow-up. Financial incentives will be awarded to participants who achieve weight lost of ?5% of baseline weight during follow-up period. The primary outcome of diabetes incidence will be assessed bi-annually and compared across the study arms. Secondary outcomes will include weight, waist circumference, fasting plasma glucose (FPG), 2-h glucose, HbA1c, physical activity, diet and metformin adherence.

Tracking Information

NCT #
NCT03503942
Collaborators
  • Ministry of Health, Singapore
  • Health Promotion Board, Singapore
  • Singapore Clinical Research Institute
  • Duke-NUS Graduate Medical School
Investigators
Principal Investigator: Yong Mong Bee Singapore General Hospital