Healthy Eating & Active Lifestyles for Diabetes: Feasibility Trial

NCT03531177 | Completed

• 1 other identifier: HEAL-DV2
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

The HEAL-D feasibility trial is a randomised control study to determine the feasibility of conducting an effectiveness trial of the Healthy Eating \& Active Lifestyles for Diabetes programme; a culturally-tailored diet and lifestyle intervention for the management of type 2 diabetes in African and Caribbean communities. In this feasibility study HEAL-D will be evaluated against usual care in 80 patients with type 2 diabetes. HEAL-D is a programme of culturally-tailored diabetes self-management education and support, delivered over 7 sessions. Key outcomes are the acceptability of the programme; and recruitment and retention of the research participants. The current study will also pilot the feasibility and acceptability to participants of measuring proposed primary and secondary outcomes including HbA1c, blood lipids (triglyceride, total cholesterol, HDL-cholesterol, LDL-cholesterol), body weight, waist circumference, diabetes knowledge, diabetes and dietary competence, diabetes empowerment, perceived social support, quality of life, dietary intake, and physical activity.

Conditions

Type2 Diabetes

Keywords

type 2 diabetes; Ethnicity; African-caribbean; Education; Self-management

Outcome Measures

Primary Outcomes (2)

• HbA1c

  glycosylated hemoglobin, mmol/mol

  6 months

• Waist circumference

  Waist circumference, cm

  6 months

Secondary Outcomes (13)

• Body weight

  6 months

• Total cholesterol

  6 months

• LDL-cholesterol

  6 months

• HDL-cholesterol

  6 months

• triglycerides

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

HEAL-D diet and lifestyle education and behavioural change intervention, 7 sessions over 14 weeks.

Behavioral: HEAL-D

Control

ACTIVE COMPARATOR

Usual care.

Behavioral: Control

Interventions

HEAL-D BEHAVIORAL

HEAL-D is a 7 session programme of self-management education and behaviour change support for African and Caribbean patients with type 2 diabetes. The sessions will support participants with behaviour change to adopt evidence-based diet and physical activity targets for type 2 diabetes. The intervention has been systematically developed with defined theory and behavioural change techniques mapped to this theory.

Intervention

Control BEHAVIORAL

Participants receive usual care from their healthcare team.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• documented diagnosis of type 2 diabetes
• self-declared African, Caribbean or Black British ethnicity

You may not qualify if:

• Complex dietetic needs e.g. advanced renal disease, making them unsuitable for general diet and lifestyle advice.
• Complex educational needs making them unsuitable for general group education.
• Unable to communicate in English.

Sponsors & Collaborators

• King's College London: lead
• University College, London: collaborator

Study Sites (1)

Guys and St Thomas NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

Related Publications (3)

• Moore AP, Rivas C, Harding S, Goff LM. A qualitative evaluation of the effectiveness of behaviour change techniques used in the Healthy Eating and Active Lifestyles for Diabetes (HEAL-D) intervention. BMC Public Health. 2025 Feb 11;25(1):568. doi: 10.1186/s12889-025-21767-8.

  PMID: 39934762 DERIVED

• Goff LM, Rivas C, Moore A, Beckley-Hoelscher N, Reid F, Harding S. Healthy Eating and Active Lifestyles for Diabetes (HEAL-D), a culturally tailored self-management education and support program for type 2 diabetes in black-British adults: a randomized controlled feasibility trial. BMJ Open Diabetes Res Care. 2021 Sep;9(1):e002438. doi: 10.1136/bmjdrc-2021-002438.

  PMID: 34518159 DERIVED

• Goff LM, Moore AP, Rivas C, Harding S. Healthy Eating and Active Lifestyles for Diabetes (HEAL-D): study protocol for the design and feasibility trial, with process evaluation, of a culturally tailored diabetes self-management programme for African-Caribbean communities. BMJ Open. 2019 Mar 1;9(2):e023733. doi: 10.1136/bmjopen-2018-023733.

  PMID: 30826792 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Louise M Goff, PhD

  King's College London

  STUDY CHAIR

• Barbara McGowan, PhD

  Guy's and St Thomas NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised model, two arms. Intervention assessed against control.

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 21, 2018
• Study Start: April 26, 2018
• Primary Completion: May 30, 2019
• Study Completion: March 30, 2020
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)