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  • Periodic Reporting for period 1 - iHealth-T2D (Family-based intervention to improve healthy lifestyle and prevent Type 2 Diabetes amongst South Asians with central obesity and prediabetes)

iHealth-T2D Report Summary

Project ID: 643774
Funded under: H2020-EU.3.1.

Periodic Reporting for period 1 - iHealth-T2D (Family-based intervention to improve healthy lifestyle and prevent Type 2 Diabetes amongst South Asians with central obesity and prediabetes)

Reporting period: 2015-01-01 to 2015-12-31

Summary of the context and overall objectives of the project

1.1. Context: Importance of the Type-2 diabetes in South Asians
South Asians, who represent one-quarter of the world’s population, are at high risk of type-2 diabetes. India alone has ~56 million people with T2D, the second highest number in the world. Conservative estimates based on population growth, ageing and rates of urbanisation show that T2D cases in India will increase to ~100 million by 2030. T2D prevalence is currently ~9% in rural India, ~18% in urban India, and ~22% amongst Indians living in Europe (compared to ~6% among Europeans). Similar patterns are observed among South Asians in Pakistan, Bangladesh, and Sri Lanka. Diabetes poses a massive clinical, economic and social burden among South Asian countries as well as in the European countries to which South Asians have emigrated in large numbers.

1.2. Aims of the research
Our general goal is to identify approaches to risk stratification and health promotion through lifestyle modification that are acceptable, effective and efficient for prevention of T2D in South Asian communities from diverse settings. To achieve this, the iHealth-T2D study will investigate whether intensive lifestyle modification vs usual care reduces risk of T2D (primary endpoint) amongst South Asians with i. central obesity; ii. prediabetes and iii. overall (with central obesity and / or obesity). In addition, we will investigate health gains amongst family members, and complete a health economic analysis to quantify the cost-effectiveness of screening by waist circumference vs HbA1c, and of lifestyle modification for prevention of T2D, on the Indian subcontinent and Europe.

1.3 Study design
This is a multi-centre, cluster randomised clinical trial to compare lifestyle modification vs usual care for prevention of T2D amongst non-diabetic South Asians with central obesity and / or prediabetes. The study comprises one year intervention and 3 years follow-up.
We will recruit 3,600 South Asian men and women aged 40-70 years with i. central obesity (waist≥100 cm) and/or ii. prediabetes (HbA1c 6.0-6.4%) to the study (Index cases). Recruitment will be from the Indian subcontinent (India, Pakistan, Sri Lanka) and Europe (UK). Index cases will receive either i. intensive lifestyle modification (N=1,800); or ii. usual care (N=1,800). Intensive lifestyle modification follows clinically accepted, evidence based strategies to achieve >7% reduction in weight through improved diet and increased physical activity, and is delivered as 9 face-face and 13 telephone contact sessions over 12 months. Index cases are the focus for the intervention, but lifestyle modification encourages the whole family to adopt healthy living. Usual care group will comprise one diabetes prevention session and written material. Index cases will be followed for three years to identify new-onset T2D (primary endpoint, HbA1c≥6.5%). Secondary outcome measures will include a range of clinical, lifestyle, psychosocial, biochemical and healthcare utilisation measures. Assessments of adiposity will also be made amongst available, consenting adult relatives of index cases in the intervention group (Relatives), to describe the potential benefit of providing health promotion to the index case in the wider family.
The primary analyses will determine the clinical and cost-effectiveness of intensive lifestyle modification vs usual care for prevention of T2D amongst South Asians with i. central obesity; ii. prediabetes or iii, overall. Secondary analyses will address behavioural, psychosocial, clinical, and biochemical measures similarly. All analyses will be intention to treat. Health economic analyses will take account of costs incurred by the government, and participants. Effectiveness will be measured in terms of screening numbers needed to identify one case of ‘high risk’ for developing diabetes, and numbers needed to treat to prevent or delay one case of diabetes. Sensitivity analysis will be undertaken to test the robustness of the analysis in terms of the cost inputs and health outcomes.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

iHealth-T2D project was launched in February 2015, with a two-day kick-off meeting. The meeting proved to be a crucial platform to discuss the aims of the project, define working groups and roles, debate challenges and strategies and to build up the consortium relationship. A further scientific meeting was held in Colombo (November 2015) to focus on finalising adaptation of study materials. The main areas of work carried out since the beginning of the project are:

2.1 Adaptation of dietary intervention protocols
The dietary documents were developed by the study nutritionists in collaboration with the nutritionists of India, Pakistan and Sri Lanka. Skype meetings were held weekly, between ICL and the partner institutions, in order to assure consistency and quality of work. All documents were adapted and tailored to each country’s reality and food culture. This proved to be a very substantial piece of work, with more than 30 documents created in English for each country, then further translated into major languages (Hindi, Punjabi, Sinhalese, Tamil and Urdu). This represents ~240 separate documents that are a unique resource for health promotion in this high risk population, including Guides and training materials for the Community Health Workers (CHW), Clinic Report Forms, Handbooks for the study participants, Handbooks for the participant’s relatives, Meal plans and food diaries.

2.2 HbA1C assays
The group have identified local laboratories for measurement of HbA1c that undertake robust internal and external QC, meet IFCC standards and are part of the IFCC network of laboratories, and using an assay that is not affected by haemoglobinopathies ( A single provider has been selected for each country based on quality standards and cost. Participating laboratories provide their internal QC and external QA data on a monthly basis for assessment of laboratory performance.

2.3 Field work sites selection
The 120 field-work sites (30 each in India, Pakistan, Sri Lanka and UK) have been identified. Each country was responsible for identifying the field-work sites for the study. In the UK, field-work sites are be GP surgeries in London serving populations with a high proportion (>25%) of South Asians. On the Indian subcontinent, field-work sites are based in a range of urban and rural settings. Socio-demographic and geographic characteristics of the field-work sites have been recorded.

2.4 Database
Bespoke databases have been written for the study. The clinical trial database is built in the InForm system, hosted by the Imperial College London Clinical Trials Unit. The database is web-enabled and accessible from all countries. In addition, a database has been custom written for storage and reporting on clinical data at a local level, and for administration of participant appointments.

2.5 Regulatory approval
Regulatory approval has been obtained for screening in all 4 countries, enabling screening to start. Approval for the intervention phase required finalisation of adapted and translated clinical intervention tools. These are now completed and ethics submission approval are being sought in each country. The Indian Council of Medical Research has approved DDF to participate in the study.

2.6 Piloting and training
Screening, recruitment and intervention clinic sessions have been piloted in all 4 countries. The piloting was used to identify and resolve potential problems, as well as to facilitate training of the staff involved in the study. Specific training manuals have been developed and adapted for the health worker and research nurse roles. The training programs were piloted amongst the lead nutritionists to ensure suitability and harmonisation across countries.

2.7 Screening
Screening for South Asians at risk of T2D has started. To date 11,362 people have attended for screening with identification of 2,845 South Asians without T2D, but who have waist circumference >100cm or HbA1c>6. This compares favourably with the anticipated target of ~4,500 eligible people needed for the study. South Asians who continue to meet the study eligibility criteria will continue to the intervention phase of the study.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Ultimately the results of this study will describe the clinical and cost-effectiveness of lifestyle intervention using a family based approach for prevention of T2D amongst prediabetic or centrally obese South Asians. The results will be used to describe the potential implications (benefits and costs) in the local and national health economies of scaling-up intensive lifestyle modification for prevention of T2D, using central obesity and / or HbA1c for screening, taking account of gender, and in different environmental settings. In the longer term, we expect our study to have potential for a major impact on the burden of T2D in South Asians.

At this stage of the project the impacts are more modest, but nevertheless appreciable. We have brought together a team of health workers from across South Asian countries, committed to prevention of T2D in this high risk population. This has enabled bidirectional sharing of ideas and knowledge, and has fostered a new sense of collaboration between centres with shared challenges. The project has also enables development of a comprehensive, fully adapted set of materials for lifestyle intervention to prevent T2D amongst South Asian men and women from diverse settings. These adapted materials alone represent a valuable clinical resource that will benefit South Asians, and the health systems of the countries they live in.

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