Healthy Eating & Active Lifestyles for Diabetes: Feasibility Trial

Type2 Diabetes Clinical Trial

— HEAL-D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03531177
• Other study ID #: HEAL-DV2
• Status: Completed
• Phase: N/A
• Start date: April 26, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: March 2021
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: March 30, 2020
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

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.
• Control
Participants receive usual care from their healthcare team.

Locations

Country	Name	City	State
United Kingdom	Guys and St Thomas NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	glycosylated hemoglobin, mmol/mol	6 months
Primary	Waist circumference	Waist circumference, cm	6 months
Secondary	Body weight	Body weight, kg	6 months
Secondary	Total cholesterol	Total cholesterol, mmol/l	6 months
Secondary	LDL-cholesterol	LDL-cholesterol, mmol/l	6 months
Secondary	HDL-cholesterol	HDL-cholesterol, mmol/l	6 months
Secondary	triglycerides	triglycerides, mmol/l	6 months
Secondary	Diabetes knowledge	Measured using the Short Diabetes Knowledge Instrument	6 months
Secondary	Perceived Diabetes & Dietary Competence	Measured using the Perceived Diabetes & Dietary Competence (PDDC) questionnaire	6 months
Secondary	Diabetes Empowerment	Measured using the Diabetes Empowerment Scale-Short Form (DES-SF). It measures an individuals psychosocial self-efficacy with regard to their type 2 diabetes management. It uses a 5 point scale: Strongly Disagree; Somewhat disagree; Neutral; Somewhat Agree; Strongly Agree Strongly Disagree has a score of 1 through to strongly agree with a score of 5. The questionnaire is scored by averaging scores for all completed items. Total score ranges from a minimum of 1 to a maximum score of 5. The higher the score the higher the self-efficacy/empowerment. There are no sub-scales in this measure.	6 months
Secondary	Perceived social support	Measured using the Multidimensional Scale of Perceived Social Support (PSS). It measures the degree to which an individual feels socially supported. Scores are on a numerical scale from 1 to 7 with 1 being the lowest social support and 7 the highest. The scores are summed. Three subscales are reported: family; friends; and significant other. Each subscale scores a minimum 4 and maximum 28. The total score ranges from 12 to 84.Higher scores indicate higher the degree of perceived social support.	6 months
Secondary	Quality of Life	The EuroQol Five Dimension Three Level (EQ-5D-3L) scale measures health status. Level 1: respondents choose one statement which best describes their health status (5 dimensions: mobility, self-care, usual activities,pain/discomfort, and anxiety/depression), coded as 1 (no problems), 2 (some problems), or 3 (extreme problems). Numerals 1-3 have no arithmetic properties and should not be used as a cardinal score.The person's health status is defined by a 5-digit number, ranging from 11111 (no problems in all dimensions) to 33333 (extreme problems in all dimensions). There are potentially 243 different scores. Level 2 is the Visual Analogue Scale giving a score from 0 to 100, higher values indicating better health. The total score ranges from 0-1, it is calculated by applying a formula that essentially attaches values ('weights') to each of the levels in each dimension. The index can be calculated by deducting the appropriate weights from 1, the value for full health (i.e. state 11111).	6 months
Secondary	Diabetes-specific Quality of Life	Measured using the Problem Areas In Diabetes-5 point scale (PAID-5). Each question has five possible answers with a value from 0 to 4, with 0 representing "no problem" and 4 "a serious problem". The scores for each of the 5 questions are added up to give a total score ranging from 0 to 20, with higher scores indicating higher degree of problems with diabetes.	6 months
Secondary	Dietary carbohydrate intake	Measured in grams/day from a 24 hour recall interview	6 months
Secondary	Physical activity	Measured as minutes of moderate intensity exercise per day using the Motion Watch accelerometer	6 months