Clinical trial NCT03531177: Healthy Eating & Active Lifestyles for Diabetes: Feasibility Trial
Official title: Healthy Eating & Active Lifestyle for Diabetes in UK African & Caribbean Communities: a Feasibility Trial With Process Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Keywords: type 2 diabetes
Ethnicity
African-caribbean
Education
Self-management
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: University College, London
First posted: 2018-05-21
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised model, two arms. Intervention assessed against control.
Primary purpose: TREATMENT

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.

Detailed description: This study is a feasibility trial with an embedded process evaluation of the HEAL-D intervention compared with usual care. The study will use a randomised controlled trial (RCT) design, with individual patients as the unit of randomisation, evaluating the HEAL-D programme against usual care. The RCT design has been chosen primarily to evaluate the feasibility of recruiting and retaining a control arm, as well as to define what constitutes 'usual care' and the variability within that. Patients with diagnosed type 2 diabetes (T2D) will be recruited from General Practice surgeries in the London Boroughs of Lambeth and Southwark. In addition participants from the phase 1 co-design study will be invited to participate and self-referral methods will also be used, for example posters and advertisements in community locations. Patients will be eligible if they have a documented diagnosis of T2D and are of self-declared African or Caribbean ethnicity. Patients with complex therapeutic dietary needs may be ineligible if their individual needs are deemed incompatible with the aims of the intervention. Additionally patients who are unable to communicate in English will be ineligible.

A pragmatic sample size of 80 randomised patients, 40 in each arm, is anticipated to be sufficient to evaluate the programme, allowing for 20% drop-out/non-completion. As this is a feasibility trial it is not powered to detect statistically significant intervention effects, unless these estimated effects are extremely large. The purpose of the study is to assess the feasibility and acceptability of the intervention and of trial methods, and to provide estimates of key parameters such as potential effect sizes, recruitment and retention rates of the trial and participation rates of the programme, so that the optimal design of a full-scale trial can be determined.

The HEAL-D intervention consists of 7 sessions; the programme will have a flexible schedule allowing participants to attend either fortnightly or monthly sessions. Each patient who participates will be in the study for approximately 7 months and will be asked to complete two assessment visits, one at baseline and one 6-8 months later, depending on the intensity of programme attendance. A range of potential primary and secondary outcome data will be collected 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. Participants may also participate in an interview or focus group as part of the study's process evaluation.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: HbA1c
timeFrame: 6 months
measure: Waist circumference
timeFrame: 6 months
Secondary outcomes:
measure: Body weight
timeFrame: 6 months
measure: Total cholesterol
timeFrame: 6 months
measure: LDL-cholesterol
timeFrame: 6 months
measure: HDL-cholesterol
timeFrame: 6 months
measure: triglycerides
timeFrame: 6 months
measure: Diabetes knowledge
timeFrame: 6 months
measure: Perceived Diabetes & Dietary Competence
timeFrame: 6 months
measure: Diabetes Empowerment
timeFrame: 6 months
measure: Perceived social support
timeFrame: 6 months
measure: Quality of Life
timeFrame: 6 months
measure: Diabetes-specific Quality of Life
timeFrame: 6 months
measure: Dietary carbohydrate intake
timeFrame: 6 months
measure: Physical activity
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust
Study officials:
affiliation: King's College London
name: Louise M Goff, PhD
role: STUDY_CHAIR
affiliation: Guy's and St Thomas NHS Foundation Trust
name: Barbara McGowan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.