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Clinical Trials/ISRCTN11913581
ISRCTN11913581
Completed
未知

Implementation of a contextualized self-management approach to prevent and manage type 2 diabetes

European Commission0 sites712 target enrollmentJanuary 10, 2017

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
European Commission
Enrollment
712
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29550780 protocol 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32265775 results (added 09/04/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36162865/ Process evaluation (added 27/09/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36962331/ (added 27/03/2023)

Registry
who.int
Start Date
January 10, 2017
End Date
March 31, 2019
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Inclusion criteria as of 01/10/2018:
  • 1\. Currently residing in, and have resided in their respective communities for at least 6 months prior to enrolment
  • 2\. Aged between 30 – 75 years
  • 3\. Have no plans of migrating out of the study area over the next 12 months from the date of enrolment
  • 4\. Able to provide written informed consent
  • 5\. Agree to home visits and follow\-up contacts as part of study participation
  • 6\. Have not been previously diagnosed with diabetes for longer than 12 months
  • 7\. Have a positive confirmatory test of pre\-diabetes or diabetes
  • Previous inclusion criteria:
  • 1\. Current residents who have resided in their respective communities for at least 6 months prior to enrolment into the study

Exclusion Criteria

  • Current exclusion criteria as of 16/10/2017:
  • 1\. Pregnancy
  • 2\. Serious mental disability
  • Previous exclusion criteria:
  • 1\. Currently known to be pregnant
  • 2\. Plans of migrating out of the study area over the next 12 months from the date of enrollment into the study
  • 3\. Previous diagnosis of diabetes, 12 months prior to enrollment into the study

Outcomes

Primary Outcomes

Not specified

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