NCT03503942

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 751 (actual)
• Sponsor: Singapore General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Pre-diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-12-30
• Primary completion: 2024-03-31
• Completion: 2024-04-15
• First posted: 2018-04-20
• Last updated: 2024-04-19

Locations

1 site across 1 country: Singapore