Pre-diabetesNCT03503942
The Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) Program
A study testing Lifestyle modification, Metformin and Financial incentives in people with Pre-diabetes, run by Singapore General Hospital at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- Lifestyle modification, Metformin and Financial incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 751 participants
- Where
- 1 siteSingapore
- Study dates
- 30 Dec 2017to 15 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singapore citizens or permanent residents
- Age between 18 and 64
- Body mass index (BMI) ≥ 23.0 kg/m2
- Pre-diabetes diagnosed based on:
- fasting plasma glucose 6.1 - 6.9 mmol/L (Impaired fasting glucose; IFG) and/or
- 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)
Who cannot join
- Individuals with diabetes mellitus
- Health conditions impeding participation in lifestyle change programme (e.g. active cancer, recent myocardial event within 6 months, heart failure, chronic kidney disease)
- Current pregnancy or breast feeding
- Treatment with medications known to alter glucose tolerance
- Known allergic reaction to metformin
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Lifestyle modification, Metformin, Financial incentives
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle modificationBehavioural
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.
MetforminDrug
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.
Financial incentivesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Participants in the treatment arm will receive structured group-based lifestyle interventions with stepwise addition of metformin for selected high-risk participants. Receives: Behavioral: Lifestyle modification; Drug: Metformin; Other: Financial incentives |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (7)
Weight
Weight in kg
Measured: 3 years
Waist circumference
Waist circumference in cm
Measured: 3 years
HbA1c
HbA1c in %
Measured: 3 years
Fasting plasma glucose
Fasting plasma glucose in mmol/L
Measured: 3 years
2-hour plasma glucose
2-hour plasma glucose post oral glucose challenge in mmol/L
Measured: 3 years
International physical activity questionnaire (IPAQ) score
IPAQ score in MET minutes a week
Measured: 3 years
Metformin adherence
Metformin adherence assessed by pill counts
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start30 Dec 2017
- Primary completion31 Mar 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 751 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Singapore, Health Promotion Board, Singapore, Singapore Clinical Research Institute, Duke-NUS Graduate Medical School
- Responsible party
- Sponsor
- Investigators
- Yong Mong Bee, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503942
- Sponsor's protocol ID
- PREDICTED2017
- Status last verified
- Apr 2024
- First submitted
- 13 Oct 2017
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34362409
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) Program
- ClinicalTrials.gov ID
- NCT03503942
- Acronym / sponsor ID
- PREDICTED2017
- Conditions
- Pre-diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 751 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, Singapore, Health Promotion Board, Singapore, Singapore Clinical Research Institute, Duke-NUS Graduate Medical School
- Study start
- 30 Dec 2017 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 20 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Behavioral: Lifestyle modification, Drug: Metformin, Other: Financial incentivesParticipants in the treatment arm will receive structured group-based lifestyle interventions with stepwise addition of metformin for selected high-risk participants. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Singapore citizens or permanent residents
- Age between 18 and 64
- Body mass index (BMI) ≥ 23.0 kg/m2
- Pre-diabetes diagnosed based on:
Key exclusion criteria (5 listed)
- Individuals with diabetes mellitus
- Health conditions impeding participation in lifestyle change programme (e.g. active cancer, recent myocardial event within 6 months, heart failure, chronic kidney disease)
- Current pregnancy or breast feeding
- Treatment with medications known to alter glucose tolerance
- Known allergic reaction to metformin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle modificationParticipants 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. | Behavioural | Treatment arm |
| MetforminMetformin 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. | Drug | Treatment arm |
| Financial incentivesParticipants 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. | Other | Treatment arm |
Primary outcome
Diabetes incidence
Time frame: 3 years
The primary outcome, diabetes incidence, will be diagnosed based on a single, annual OGTT or the semi-annual FPG (Fasting plasma glucose) test
7 secondary outcomes
Weight
Time frame: 3 years
Waist circumference
Time frame: 3 years
HbA1c
Time frame: 3 years
Fasting plasma glucose
Time frame: 3 years
2-hour plasma glucose
Time frame: 3 years
International physical activity questionnaire (IPAQ) score
Time frame: 3 years
Metformin adherence
Time frame: Up to 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Derived from this study: PubMed 34362409Yeung 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.
- Individual participant dataSharing planned: No
Related trials for Pre-diabetes
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
Recruiting
Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes
PreDiabetes, Diet, Healthy
Active, not recruiting
The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Mong Bee principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle modification, Metformin and Financial incentives in people with Pre-diabetes, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes incidence (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03503942, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.