Community-based Prevention of Diabetes (ComPoD) trial

Phase 3

Completed

• Conditions: Topic: Diabetes, Primary Care; Subtopic: Type 2, Diabetes, Primary care; Disease: All Diseases, Prevention/screening; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN70221670
• Lead Sponsor: niversity of Exeter (UK)

Brief Summary

2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31771589 (added 31/12/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-05
• Study Completion: 2016-12-31
• Last Update Posted: 21 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 314

Inclusion Criteria

As per existing programme eligibility criteria we will recruit people who:
1. Are aged 18-74 years.
2. Are considered on the basis of recent blood glucose tests to be at high risk for type 2 diabetes according to the criteria in the recent NICE diabetes prevention guidance (fasting plasma glucose level 6.1-
6.9 mmol/L, or HBA1c 42-47 mmol/l recorded at any point within the last year). A check for progression to diabetes amongst trial participants will be made at baseline using point-of-testing HbA1c assessment equipment.
3. Are resident in Exeter and Tiverton (postcodes EX1-6; EX 16) or Birmingham (postcodes B1-21).
4. Have a BMI of at least 25 (23 for certain ethnic minority populations e.g. South Asians) and less than 45 kg/m2

Exclusion Criteria

1. We will exclude people who have a terminal illness or do not have the mental capacity to give informed consent and understand study procedures with assistance from the researcher, an interpreter or other representative as necessary (e.g., due to dementia, severe learning disability)
2. Participants who have an HbA1c reading recorded at their baseline assessment indicating progression to Type 2 diabetes will also be excluded from the trial but will still be able to access the diabetes management component of the Living Well, Taking Control programme and will be referred accordingly

There are no other exclusion criteria as the programme providers cater for people with low literacy, needing translation services or with mental health problems, learning or physical disabilities, and will support consenting and collecting data from these groups.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight loss (kg); Timepoint(s): Baseline, 6 months, 12 months