CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 77 enrolled
Drug / intervention
HEAL-D +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03531177
NCT03531177N/ACompleted

Healthy Eating & Active Lifestyle for Diabetes in UK African & Caribbean Communities: a Feasibility Trial With Process Evaluation

King's College London·interventional·Posted May 21, 2018·Updated Mar 10, 2021

In Brief

A clinical study evaluating HEAL-D and Control for Type2 Diabetes. Completed, enrolled 77 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType2 Diabetes
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMay 21, 2018
Enrollment StartApr 26, 2018
Primary CompletionMay 30, 2019
Study CompletionMar 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.1 years ago

Interventions

HEAL-Dbehavioral

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.

Controlbehavioral

Participants receive usual care from their healthcare team.