Evidence map›Paper›PMID 41027027›Full record

ArticleJMIR research protocols2025

Culturally Tailored Diabetes Self-Management Education and Support Programs in Black African and Caribbean Adults With Type 2 Diabetes (HEAL-D): Protocol for a Multicenter, Pragmatic Randomized Controlled Trial.

Louise M Goff, Drusus A Johnson, Vicky Bell, Susan Blyden, Peter Bower, Jeremy Dale, Tess Harris, Andrew Healey, Eleanor Hoverd, Huajie Jin and 8 more

Abstract readClinical Trial Protocol
In one paragraph

Article in JMIR research protocols, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Louise M GoffDiabetes Research Centre, University of Leicester, Leicester, United Kingdom.ORCID 0000-0001-9633-8759
Drusus A JohnsonDiabetes Research Centre, University of Leicester, Leicester, United Kingdom.ORCID 0009-0009-6876-3964
Vicky BellSchool of Health Sciences, University of Manchester, Manchester, United Kingdom.ORCID 0000-0002-2405-0673
Susan BlydenUnit of Academic Primary Care, University of Warwick, Coventry, United Kingdom.ORCID 0009-0003-8271-0566
Peter BowerSchool of Health Sciences, University of Manchester, Manchester, United Kingdom.ORCID 0000-0001-9558-3349
Jeremy DaleUnit of Academic Primary Care, University of Warwick, Coventry, United Kingdom.ORCID 0000-0001-9256-3553
Tess HarrisPopulation Health Research Institute, City St George's, University of London, London, United Kingdom.ORCID 0000-0002-8671-1553
Andrew HealeyKing's Health Economics, King's College London, London, United Kingdom.ORCID 0000-0003-2013-3161
Eleanor HoverdUnit of Academic Primary Care, University of Warwick, Coventry, United Kingdom.ORCID 0000-0002-8482-655X
Huajie JinKing's Health Economics, King's College London, London, United Kingdom.ORCID 0000-0002-3872-3998
Tony KellyPublic Citizen, Birmingham, United Kingdom.
Carol RivasSocial Research Institute, University College London, London, United Kingdom.ORCID 0000-0002-0316-8090
Clare RobinsonPragmatic Clinical Trials Unit, Queen Mary University of London, London, United Kingdom.ORCID 0000-0002-2673-2205
Jayne ThorpeSouth West London Integrated Care Board, London, United Kingdom.ORCID 0000-0002-4069-0638
Sandra TomlinsonPublic Citizen, London, United Kingdom.ORCID 0000-0002-2765-1407
Michael UssherPopulation Health Research Institute, City St George's, University of London, London, United Kingdom.ORCID 0000-0002-0995-7955
Charlotte WahlichPopulation Health Research Institute, City St George's, University of London, London, United Kingdom.ORCID 0000-0003-3450-5210
Barbara McGowanKing's Health Economics, King's College London, London, United Kingdom.ORCID 0000-0003-2015-726X

Funding

National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Program ( NIHR151372
6 · The paper itself

Abstract

backgroundPeople of Black African and Black Caribbean ethnicity experience higher rates and poorer outcomes of type 2 diabetes (T2D) than people of White European ethnicity; these inequalities are compounded by poor healthcare access. Cultural tailoring of diabetes self-management education and support (DSMES) programs has the potential to improve healthcare engagement and clinical outcomes for ethnic minority groups. Healthy Eating & Active Lifestyles for Diabetes (HEAL-D) is a co-designed, culturally tailored group-based DSMES program for adults of Black African and Black Caribbean ethnicity.

objectiveThis trial aims to evaluate the clinical and cost effectiveness of the HEAL-D intervention, compared to standard DSMES programs, in Black African and Black Caribbean adults living with T2D.

methodsA 24-month, multicenter, pragmatic, open-label, 2-arm, parallel-group, individually randomized group treatment trial will be conducted, with primary end point (glycated hemoglobin [HbA

resultsFunding began in August 2023. Site "green light" was received on August 15, 2024, for London; November 29, 2024, for Manchester; and January 31, 2025, for the West Midlands. Recruitment commenced in August 2024 and is due to run for 11 months. As of March 26, 2025, a total of 76 participants have consented. Last patient, last visit is expected in June 2027; primary data analysis is expected to begin in July 2027. Final results are anticipated to be available in September 2027, and publication is expected by the end of 2027.

conclusionsThe HEAL-D trial will address whether a culturally tailored DSMES program, provided in-person or via videoconferencing, is clinically and cost-effective compared to standard DSMES at improving diabetes management in Black African and Black Caribbean adults. If effective, this would provide an evidence-based model of equitable DSMES services and improve the implementation of healthcare programs for ethnic minority groups.

trial registrationISRCTN 1434448; https://www.isrctn.com/ISRCTN14344948. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/71861.

Indexed as

Black PeopleDiabetes Mellitus, Type 2Patient Education as TopicSelf-ManagementAdultCaribbean RegionCost-Benefit AnalysisFemaleGlycated HemoglobinHumansMaleMiddle AgedMulticenter Studies as TopicPragmatic Clinical Trials as TopicUnited KingdomGlycated Hemoglobinclinical trialeducationethnicityprotocolself-managementtype 2 diabetes

Identifiers

PMID41027027
PMCPMC12521847

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.