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The Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) Program

NCT03503942 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 751

Last updated 2024-04-19

No results posted yet for this study

Summary

The Pre-DICTED (Pre-Diabetes Intervention and Continued Tracking to Ease-out Diabetes) program is a community-based diabetes prevention program. This study aims to test the effectiveness of structured, group-based lifestyle interventions with stepwise addition of metformin, if required, among subjects with pre-diabetes in multi-ethnic Singapore.

Conditions

  • Pre-diabetes

Interventions

BEHAVIORAL

Lifestyle modification

Participants in the treatment arm will receive structured, locally tailored, group-based lifestyle interventions that consist of a core intervention phase (3 months) and a maintenance phase (33 months). The core intervention phase will consist of twice weekly group sessions on nutrition, exercise and goal-setting within the first 6 weeks followed by 6 weeks of self-directed lifestyle modification. During the maintenance phase, the participants will receive monthly short message service (SMS) on health tips as well as 6 monthly telephone calls from program coordinators.

DRUG

Metformin

Metformin will be will be prescribed to treatment group participants at highest risk of diabetes conversion (i.e.IFG + IGT or IFG + HbA1c ≥6.0%) after at least 6 months of lifestyle interventions at a starting dose of 250 mg twice a day followed by up-titration to 500 mg twice a day after 3 months if the participants do not experience any gastrointestinal side effects.

OTHER

Financial incentives

Participants will be given cash incentives if they meet the weight loss target, which is pre-defined as 5% of baseline weight, at the 3rd, 6th, 12th, 18th, 24th, 30th and 36th month of study period.

Sponsors & Collaborators

  • Ministry of Health, Singapore

    collaborator OTHER_GOV

  • Health Promotion Board, Singapore

    collaborator OTHER_GOV

  • Singapore Clinical Research Institute

    collaborator OTHER

  • Duke-NUS Graduate Medical School

    collaborator OTHER

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Yong Mong Bee · Singapore General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-30
Primary Completion
2024-03-31
Completion
2024-04-15

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03503942 on ClinicalTrials.gov