A people-centred approach through Self-Management and Reciprocal learning for the prevention and management of Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type 2 diabetes and pre-diabetes; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN11913581
• Lead Sponsor: European Commission

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-10
• Study Completion: 2019-03-31
• Last Update Posted: 10 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 712

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
2. Aged 30 – 75 years
3. Able to provide written informed consent
4. Agree to allow home visits or follow-up contacts as part of participating in the trial
5. Have a positive confirmatory test of pre-diabetes or diabetes following screening or within past 12 months of trial start. In Sweden, this includes high risk of diabetes based on FINDRISC scores.

Previous inclusion criteria as of 16/10/2017:
1. Currently residing in, and have resided in their respective communities for at least 6 months prior to enrollment
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 enrollment
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 enrollment into the study
2. Aged 30 – 75 years
3. Able to provide written informed consent
4. Agree to allow home visits or follow-up contacts as part of participating in the trial
5. Have a positive confirmatory test of pre-diabetes or diabetes following screening or within past 12 months of trial start

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified