Type2 DiabetesHEAL-DNCT03531177
Healthy Eating & Active Lifestyles for Diabetes: Feasibility Trial
A study testing HEAL-D in people with Type2 Diabetes, run by King's College London at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- HEAL-D
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Apr 2018to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- documented diagnosis of type 2 diabetes
- self-declared African, Caribbean or Black British ethnicity
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guys and St Thomas NHS Foundation Trust
London, SE1 9RT
About this study
Official title: Healthy Eating & Active Lifestyle for Diabetes in UK African & Caribbean Communities: a Feasibility Trial With Process Evaluation
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.
Read the 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.
- Conditions
- Type2 Diabetes
- Being tested
- HEAL-D, Control
- Keywords
- type 2 diabetes, Ethnicity, African-caribbean, Education, Self-management
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEAL-DBehavioural
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.
ControlBehavioural
Participants receive usual care from their healthcare team.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | HEAL-D diet and lifestyle education and behavioural change intervention, 7 sessions over 14 weeks. Receives: Behavioral: HEAL-D |
| Control | Active comparator | Usual care. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
glycosylated hemoglobin, mmol/mol
Measured: 6 months
Waist circumference
Waist circumference, cm
Measured: 6 months
Secondary outcomes (13)
Body weight
Body weight, kg
Measured: 6 months
Total cholesterol
Total cholesterol, mmol/l
Measured: 6 months
LDL-cholesterol
LDL-cholesterol, mmol/l
Measured: 6 months
HDL-cholesterol
HDL-cholesterol, mmol/l
Measured: 6 months
triglycerides
triglycerides, mmol/l
Measured: 6 months
Diabetes knowledge
Measured using the Short Diabetes Knowledge Instrument
Measured: 6 months
Perceived Diabetes & Dietary Competence
Measured using the Perceived Diabetes \& Dietary Competence (PDDC) questionnaire
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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).
Measured: 6 months
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.
Measured: 6 months
Dietary carbohydrate intake
Measured in grams/day from a 24 hour recall interview
Measured: 6 months
Physical activity
Measured as minutes of moderate intensity exercise per day using the Motion Watch accelerometer
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start26 Apr 2018
- Primary completion30 May 2019
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised model, two arms. Intervention assessed against control.
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Sponsor
- Investigators
- Louise M Goff, PhD, Study chair, King's College LondonBarbara McGowan, PhD, Principal investigator, Guy's and St Thomas NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531177
- Sponsor's protocol ID
- HEAL-DV2
- Acronym
- HEAL-D
- Status last verified
- Mar 2021
- First submitted
- 3 May 2018
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moore AP, Rivas C, Harding S, Goff LM. A qualitative evaluation of the effectiveness of behaviour change techniques used in the Healthy Eating and Active Lifestyles for Diabetes (HEAL-D) intervention. BMC Public Health. 2025 Feb 11;25(1):568. doi: 10.1186/s12889-025-21767-8.
PubMed 39934762Goff 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.
PubMed 34518159Goff 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.
PubMed 30826792
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Eating & Active Lifestyle for Diabetes in UK African & Caribbean Communities: a Feasibility Trial With Process Evaluation
- ClinicalTrials.gov ID
- NCT03531177
- Acronym / sponsor ID
- HEAL-D / HEAL-DV2
- Conditions
- Type2 Diabetes
- Keywords
- type 2 diabetes, Ethnicity, African-caribbean, Education, Self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised model, two arms. Intervention assessed against control.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: HEAL-DHEAL-D diet and lifestyle education and behavioural change intervention, 7 sessions over 14 weeks. |
| Control | Active comparator | Behavioral: ControlUsual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- documented diagnosis of type 2 diabetes
- self-declared African, Caribbean or Black British ethnicity
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEAL-DHEAL-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. | Behavioural | Intervention |
| ControlParticipants receive usual care from their healthcare team. | Behavioural | Control |
Primary outcome
HbA1c
Time frame: 6 months
glycosylated hemoglobin, mmol/mol
Waist circumference
Time frame: 6 months
Waist circumference, cm
13 secondary outcomes
Body weight
Time frame: 6 months
Total cholesterol
Time frame: 6 months
LDL-cholesterol
Time frame: 6 months
HDL-cholesterol
Time frame: 6 months
triglycerides
Time frame: 6 months
Diabetes knowledge
Time frame: 6 months
Perceived Diabetes & Dietary Competence
Time frame: 6 months
Diabetes Empowerment
Time frame: 6 months
Perceived social support
Time frame: 6 months
Quality of Life
Time frame: 6 months
Diabetes-specific Quality of Life
Time frame: 6 months
Dietary carbohydrate intake
Time frame: 6 months
Physical activity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Derived from this study: PubMed 39934762Moore AP, Rivas C, Harding S, Goff LM. A qualitative evaluation of the effectiveness of behaviour change techniques used in the Healthy Eating and Active Lifestyles for Diabetes (HEAL-D) intervention. BMC Public Health. 2025 Feb 11;25(1):568. doi: 10.1186/s12889-025-21767-8.
- Derived from this study: PubMed 34518159Goff 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.
- Derived from this study: PubMed 30826792Goff 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise M Goff, PhD study chair
King's College London
Barbara McGowan, PhD principal investigator
Guy's and St Thomas NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEAL-D in people with Type2 Diabetes, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03531177, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.