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

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.

Study Overview

• Status: Completed
• Conditions: Pre-diabetes
• Intervention / Treatment: Behavioral: Lifestyle modification; Drug: Metformin; Other: Financial incentives

Detailed 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 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.

• Study Type: Interventional
• Enrollment (Actual): 751
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Singapore citizens or permanent residents
2. Age between 18 and 64
3. Body mass index (BMI) ≥ 23.0 kg/m2

4. Pre-diabetes diagnosed based on:

   1. fasting plasma glucose 6.1 - 6.9 mmol/L (Impaired fasting glucose; IFG) and/or
   2. 2-hr plasma glucose in 75g oral glucose tolerance test (OGTT) 7.8 - 11.0 mmol/L (Impaired glucose tolerance; IGT) (Laboratory tests to be done within 6 months of enrolment)

Exclusion Criteria:

1. Individuals with diabetes mellitus
2. Health conditions impeding participation in lifestyle change programme (e.g. active cancer, recent myocardial event within 6 months, heart failure, chronic kidney disease)
3. Current pregnancy or breast feeding
4. Treatment with medications known to alter glucose tolerance
5. Known allergic reaction to metformin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm; Participants in the treatment arm will receive structured group-based lifestyle interventions with stepwise addition of metformin for selected high-risk participants.	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.
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes incidence	The primary outcome, diabetes incidence, will be diagnosed based on a single, annual OGTT or the semi-annual FPG (Fasting plasma glucose) test	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Weight in kg	3 years
Waist circumference	Waist circumference in cm	3 years
HbA1c	HbA1c in %	3 years
Fasting plasma glucose	Fasting plasma glucose in mmol/L	3 years
2-hour plasma glucose	2-hour plasma glucose post oral glucose challenge in mmol/L	3 years
International physical activity questionnaire (IPAQ) score	IPAQ score in MET minutes a week	3 years
Metformin adherence	Metformin adherence assessed by pill counts	Up to 30 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Yeung KF, Gandhi M, Lam AYR, Julianty S, Chia AYM, Tan GCS, Goh SY, Ho ETL, Koh AFY, Tan GSW, Shum EJW, Finkelstein EA, Jafar TH, Teoh YL, van Dam RM, Whitton C, Thumboo J, Bee YM. The Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) program: study protocol for a randomized controlled trial. Trials. 2021 Aug 6;22(1):522. doi: 10.1186/s13063-021-05500-5.

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2017
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): April 15, 2024

Study Registration Dates

• First Submitted: October 13, 2017
• First Submitted That Met QC Criteria: April 11, 2018
• First Posted (Actual): April 20, 2018

Study Record Updates

• Last Update Posted (Estimated): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Prediabetic State; Glucose Intolerance; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: PREDICTED2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No