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Healthy Eating & Active Lifestyles for Diabetes: Feasibility Trial (HEAL-D)

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ClinicalTrials.gov Identifier: NCT03531177
Recruitment Status : Completed
First Posted : May 21, 2018
Last Update Posted : March 10, 2021
Sponsor:
Collaborator:
University College, London
Information provided by (Responsible Party):
King's College London

Tracking Information
First Submitted Date  ICMJE May 3, 2018
First Posted Date  ICMJE May 21, 2018
Last Update Posted Date March 10, 2021
Actual Study Start Date  ICMJE April 26, 2018
Actual Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2018)
  • HbA1c [ Time Frame: 6 months ]
    glycosylated hemoglobin, mmol/mol
  • Waist circumference [ Time Frame: 6 months ]
    Waist circumference, cm
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2018)
  • Body weight [ Time Frame: 6 months ]
    Body weight, kg
  • Total cholesterol [ Time Frame: 6 months ]
    Total cholesterol, mmol/l
  • LDL-cholesterol [ Time Frame: 6 months ]
    LDL-cholesterol, mmol/l
  • HDL-cholesterol [ Time Frame: 6 months ]
    HDL-cholesterol, mmol/l
  • triglycerides [ Time Frame: 6 months ]
    triglycerides, mmol/l
  • Diabetes knowledge [ Time Frame: 6 months ]
    Measured using the Short Diabetes Knowledge Instrument
  • Perceived Diabetes & Dietary Competence [ Time Frame: 6 months ]
    Measured using the Perceived Diabetes & Dietary Competence (PDDC) questionnaire
  • Diabetes Empowerment [ Time Frame: 6 months ]
    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.
  • Perceived social support [ Time Frame: 6 months ]
    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.
  • Quality of Life [ Time Frame: 6 months ]
    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).
  • Diabetes-specific Quality of Life [ Time Frame: 6 months ]
    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.
  • Dietary carbohydrate intake [ Time Frame: 6 months ]
    Measured in grams/day from a 24 hour recall interview
  • Physical activity [ Time Frame: 6 months ]
    Measured as minutes of moderate intensity exercise per day using the Motion Watch accelerometer
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Healthy Eating & Active Lifestyles for Diabetes: Feasibility Trial
Official Title  ICMJE Healthy Eating & Active Lifestyle for Diabetes in UK African & Caribbean Communities: a Feasibility Trial With Process Evaluation
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomised model, two arms. Intervention assessed against control.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type2 Diabetes
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Intervention
    HEAL-D diet and lifestyle education and behavioural change intervention, 7 sessions over 14 weeks.
    Intervention: Behavioral: HEAL-D
  • Active Comparator: Control
    Usual care.
    Intervention: Behavioral: Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 16, 2019)
77
Original Estimated Enrollment  ICMJE
 (submitted: May 18, 2018)
80
Actual Study Completion Date  ICMJE March 30, 2020
Actual Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03531177
Other Study ID Numbers  ICMJE HEAL-DV2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party King's College London
Study Sponsor  ICMJE King's College London
Collaborators  ICMJE University College, London
Investigators  ICMJE
Study Chair: Louise M Goff, PhD King's College London
Principal Investigator: Barbara McGowan, PhD Guy's and St Thomas NHS Foundation Trust
PRS Account King's College London
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP