- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03531177
Healthy Eating & Active Lifestyles for Diabetes: Feasibility Trial (HEAL-D)
Healthy Eating & Active Lifestyle for Diabetes in UK African & Caribbean Communities: a Feasibility Trial With Process Evaluation
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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London, Royaume-Uni, SE1 9RT
- Guys and St Thomas Nhs Foundation Trust
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Intervention
HEAL-D diet and lifestyle education and behavioural change intervention, 7 sessions over 14 weeks.
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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.
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Comparateur actif: Control
Usual care.
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Participants receive usual care from their healthcare team.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
HbA1c
Délai: 6 months
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glycosylated hemoglobin, mmol/mol
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6 months
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Waist circumference
Délai: 6 months
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Waist circumference, cm
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6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Body weight
Délai: 6 months
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Body weight, kg
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6 months
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Total cholesterol
Délai: 6 months
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Total cholesterol, mmol/l
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6 months
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LDL-cholesterol
Délai: 6 months
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LDL-cholesterol, mmol/l
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6 months
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HDL-cholesterol
Délai: 6 months
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HDL-cholesterol, mmol/l
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6 months
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triglycerides
Délai: 6 months
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triglycerides, mmol/l
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6 months
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Diabetes knowledge
Délai: 6 months
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Measured using the Short Diabetes Knowledge Instrument
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6 months
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Perceived Diabetes & Dietary Competence
Délai: 6 months
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Measured using the Perceived Diabetes & Dietary Competence (PDDC) questionnaire
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6 months
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Diabetes Empowerment
Délai: 6 months
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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.
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6 months
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Perceived social support
Délai: 6 months
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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.
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6 months
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Quality of Life
Délai: 6 months
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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).
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6 months
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Diabetes-specific Quality of Life
Délai: 6 months
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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.
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6 months
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Dietary carbohydrate intake
Délai: 6 months
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Measured in grams/day from a 24 hour recall interview
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6 months
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Physical activity
Délai: 6 months
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Measured as minutes of moderate intensity exercise per day using the Motion Watch accelerometer
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6 months
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Louise M Goff, PhD, King's College London
- Chercheur principal: Barbara McGowan, PhD, Guy's and St Thomas NHS Foundation Trust
Publications et liens utiles
Publications générales
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HEAL-DV2
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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