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Study protocol
Yong Mong Bee
Singapore General Hospital
Corresponding Author
ORCiD: https://orcid.org/0000-0002-5482-2646
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
Community-based diabetes prevention programs varied widely in effectiveness, and the intervention strategy consisting of lifestyle interventions, stepwise addition of metformin and financial incentives has not been studied in real-world clinical practice settings. The Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) trial is a pragmatic trial that aims to compare the effectiveness of a community-based stepwise diabetes prevention program with added financial incentives (intervention) versus the standard of care (control) in reducing the risk of type 2 diabetes over 3 years among overweight or obese individuals with pre-diabetes.
Methods
This is an open-label, 1:1 randomized controlled trial which aims to recruit 846 adult individuals with isolated impaired fasting glucose (IFG), isolated impaired glucose tolerance (IGT), or both IFG and IGT from Singapore. Intervention arm participants attend 12 group-based sessions (2 nutrition workshops, 9 exercise sessions and a goal-setting workshop) delivered at community sites (weeks 1 to 6), receive weekly physical activity and nutrition recommendations delivered by printed worksheets (weeks 7 to 12), and receive monthly health tips delivered by text messages (months 4 to 36). From month 6 onwards, intervention arm participants who remain at the highest risk of conversion to diabetes are prescribed metformin. Intervention arm participants are also eligible for a payment/rewards program with incentives tied to attendance at the group sessions and achievement of the weight loss target (5% of baseline weight). All participants are assessed at baseline, month 3, month 6, and every 6 months subsequently till month 36. The primary endpoint is the proportion of participants with diabetes at 3 years. Secondary endpoints include the mean change from baseline at 3 years in fasting plasma glucose, 2-hour plasma glucose, HbA1c, body weight, body mass index, physical activity and dietary intake.
Discussion
The Pre-DICTED trial will provide evidence of the effectiveness and feasibility of a community-based stepwise diabetes prevention program with added financial incentives for individuals with pre-diabetes in Singapore. The study will provide data for a future cost-effectiveness analysis, which will be used to inform policymakers of the value of a nationwide implementation of the diabetes prevention program.
Trial registration
ClinicalTrials.gov ID: NCT03503942; April 20, 2018 retrospectively registered; https://clinicaltrials.gov/ct2/show/NCT03503942
Protocol version: 5.0 Date: 1 March 2019
Keywords
Diabetes, pre-diabetes, prevention
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CURRENT STATUS: Published
View the published article at Trials.
Version 1
Posted 07 Jun, 2021
No community comments so far
Editorial decision: Minor revision
On 04 Jul, 2021
Review #1 received
Received 29 Jun, 2021
Reviewer #3 agreed
On 22 Jun, 2021
Reviewer #2 agreed
On 21 Jun, 2021
Reviewer #1 agreed
On 20 Jun, 2021
Reviews received
Received 20 Jun, 2021
Reviewers invited
Invitations sent on 19 Jun, 2021
Editor assigned
On 16 Jun, 2021
Submission checks complete
On 03 Jun, 2021
First submitted
On 30 Mar, 2021
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Learn more about our company.
A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Yong Mong Bee
Singapore General Hospital
Corresponding Author
ORCiD: https://orcid.org/0000-0002-5482-2646
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
Version 1
Posted 07 Jun, 2021
No community comments so far
Editorial decision: Minor revision
On 04 Jul, 2021
Review #1 received
Received 29 Jun, 2021
Reviewer #3 agreed
On 22 Jun, 2021
Reviewer #2 agreed
On 21 Jun, 2021
Reviewer #1 agreed
On 20 Jun, 2021
Reviews received
Received 20 Jun, 2021
Reviewers invited
Invitations sent on 19 Jun, 2021
Editor assigned
On 16 Jun, 2021
Submission checks complete
On 03 Jun, 2021
First submitted
On 30 Mar, 2021
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
Background
Community-based diabetes prevention programs varied widely in effectiveness, and the intervention strategy consisting of lifestyle interventions, stepwise addition of metformin and financial incentives has not been studied in real-world clinical practice settings. The Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) trial is a pragmatic trial that aims to compare the effectiveness of a community-based stepwise diabetes prevention program with added financial incentives (intervention) versus the standard of care (control) in reducing the risk of type 2 diabetes over 3 years among overweight or obese individuals with pre-diabetes.
Methods
This is an open-label, 1:1 randomized controlled trial which aims to recruit 846 adult individuals with isolated impaired fasting glucose (IFG), isolated impaired glucose tolerance (IGT), or both IFG and IGT from Singapore. Intervention arm participants attend 12 group-based sessions (2 nutrition workshops, 9 exercise sessions and a goal-setting workshop) delivered at community sites (weeks 1 to 6), receive weekly physical activity and nutrition recommendations delivered by printed worksheets (weeks 7 to 12), and receive monthly health tips delivered by text messages (months 4 to 36). From month 6 onwards, intervention arm participants who remain at the highest risk of conversion to diabetes are prescribed metformin. Intervention arm participants are also eligible for a payment/rewards program with incentives tied to attendance at the group sessions and achievement of the weight loss target (5% of baseline weight). All participants are assessed at baseline, month 3, month 6, and every 6 months subsequently till month 36. The primary endpoint is the proportion of participants with diabetes at 3 years. Secondary endpoints include the mean change from baseline at 3 years in fasting plasma glucose, 2-hour plasma glucose, HbA1c, body weight, body mass index, physical activity and dietary intake.
Discussion
The Pre-DICTED trial will provide evidence of the effectiveness and feasibility of a community-based stepwise diabetes prevention program with added financial incentives for individuals with pre-diabetes in Singapore. The study will provide data for a future cost-effectiveness analysis, which will be used to inform policymakers of the value of a nationwide implementation of the diabetes prevention program.
Trial registration
ClinicalTrials.gov ID: NCT03503942; April 20, 2018 retrospectively registered; https://clinicaltrials.gov/ct2/show/NCT03503942
Protocol version: 5.0 Date: 1 March 2019
Figure 1
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