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Healthy Eating & Active Lifestyles for Diabetes: Feasibility Trial

NCT03531177 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2021-03-10

No results posted yet for this study

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

Interventions

BEHAVIORAL

HEAL-D

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.

BEHAVIORAL

Control

Participants receive usual care from their healthcare team.

Sponsors & Collaborators

Principal Investigators

  • Louise M Goff, PhD · King's College London

  • Barbara McGowan, PhD · Guy's and St Thomas NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-26
Primary Completion
2019-05-30
Completion
2020-03-30

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03531177 on ClinicalTrials.gov