Can the Happy Village Plus population-based health promotion intervention be successfully implemented to reduce risk factors of cardiovascular disease and type-2 diabetes in adults living in the districts of Colombo and Gampaha, Sri Lanka?

Study setting:

Western province, Colombo District and Gampaha Districts In the Colombo and Gampaha districts of the Western province, there are several divisions, of which half will be chosen as intervention and half as control sites. The Intervention and Control groups will be Grama Niladhari divisions located in separate Divisional Secretariats within the same district in order to minimize contamination. Since there are 12 divisions with surveillance sites, there will be 6 intervention sites and 6 control sites in the Western province. . The sites are as follows.

Intervention sites in Colombo 1. Rukmalgama (Rukmale East B) 2. Jamburaliya 3. Dahampura Intervention sites of Gampaha 1. Ganagabada East (Peliyagoda) 2. Thalgasmote 3. Narampola Control sites of Colombo 1. Mattegoda East 2. Atthidiya North 3. Aembilladeniya

Control sites of Gampaha 1. Kochchikade 2. Weliweriya North 3. Ihala Karagahamuna

It is a randomized trial. The cluster random allocation is to reduce the potential effect of contamination due to the whole population approach in each surveillance site. The unit of randomization will be a Grama Niladhari division selected for the study. The cluster will comprise the adult population living within the selected Grama Niladhari division.

Clusters were randomized according to a computer-generated sequence using www.random.org

Happy village is a cluster of 50-100 houses in a village/ Grama niladari (GN) area permanently living in a same geographical area. At the village level, the responsible health officer is Medical Officer of Health, with support from health workers such as Health Education Officer (HEO) and community volunteers. Each volunteer group consists of 5-10 people from the community of each site. The volunteers will receive training on basic communication, teamwork, happy village process, grassroots level NCD prevention and health promotions, problem identification and prioritization, feasibility assessment and basics of project planning.

The Happy Village Plus is a population-based community empowerment intervention package that includes bottom-up and top-down activities.

There are four groups of top down activities: i) advocacy and health promotion ii) environmental mapping and village data; iii) social marketing; iv) healthy meal policy.

i) Advocacy and health promotion officer (HPO): Repeated and sustained advocacy will be conducted to reinforce existing policies to promote awareness of risk factors as well as to raise awareness of multisectoral collaboration at the community, divisional, and district levels. We will be also introducing an HPO who will facilitate empowerment with health staff, non-health staff, volunteers, and community groups. Who administers the intervention: Health Promotion Officer Duration: one year Frequency: continuously

ii) Environmental mapping and village data

Results from the environmental mapping and village-level data will be provided for the community, volunteers, and local stakeholders. The aim is to help them better understand local health status and the environmental exposure for advocacy purposes. The environmental mapping gathers information on retailers and advertisements for food and tobacco and physical activity facilities in each site. Also, the village-level data on CVDs, T2D, and their risk factors will be aggregated from the surveillance data.

Who administers the intervention: Health Promotion Officer Duration: one year Frequency: continuously

iii). Social marketing

Social marketing aims to influence healthy behaviours among adults in the community through positive messages. We will be exploring multiple channels to convey as well as the evidence that supports the scope and approach through mass media, targeted media, social mobilization, and community outreach.

Who administers the intervention: Health Promotion Officer Duration: one year Frequency: continuously

iv). The Healthy Meal Policy

The healthy meal policy activities focus around providing healthy meals by increasing the availability in the community providing nudges and incentives for healthy food choices to adults in the community. We will collaborate with local chefs to create healthy meal alternatives to be promoted for homes. Local Chefs are housewives skilled in cooking and trained on healthy cooking options by renowned chefs who are promoting healthy cooking practices under the guidance of the Health Promotion Officers.

Who administers the intervention: Health Promotion Officer Duration: one year Frequency: continuously

The intervention will be conducted daily for a period of one year by trained volunteers led by health promotion officers with annual follow-ups for two years.

This will be conducted open trial as it is not possible to keep the assessor unaware of the intervention/ control status. However the assessors will independent research staff who will only collect outcome data (and not be involved in the intervention). The social marketing and social messages will be delivered to social media (e.g. WhatsApp) groups created within and confined to the intervention communities.

Registration and consent. Written, informed consent is obtained from all participants for data collection, and inclusion in the research. Informed consent includes permission for the data and samples collected to be used for chronic disease research, including data sharing with national and international bodies concerned with prevention and control of T2DM and CVD, as well as for molecular epidemiological research. Consent is facilitated using videos (available in major South Asian languages) and supported by bilingual translators. A unique study ID is allocated to each participant.

Questionnaire: An interviewer-administered health and lifestyle questionnaire is used to collect information on behavioural risk factors (smoking, alcohol habit, physical activity and fruits/vegetables consumption), personal and family medical history, medications, socio-economic status. The questionnaire is founded on the extended WHO STEPwise approach to Surveillance (STEPS) questionnaire that is widely used in global disease surveillance, but was adapted for use in South Asia context, through incorporation of additional questions.

Questionnaire will also include several questions to assess social relations of community participants. There participants will be asked to nominate persons in their community to whom they are connected in different instances in their day to day life. They will be asked to nominate them by commonly used names and those named will be linked with registered names with the help of volunteers or GN.

Physical measurements. These include: a) Anthropometry (height, weight, waist and hip circumference and bio-impedance for body fat composition); b) Blood pressure by digital device; c) Cardiac evaluation by 12 lead ECG to identify arrhythmia, left ventricular hypertrophy and previous myocardial infarction; d) Retinal photography for assessment of retinal disease, including hypertensive and diabetic retinopathy; and e). Respiratory evaluation by spirometry to assess for smoking/environment-related lung injury.

Biological samples. 25ml venous blood is collected using venesection by trained phlebotomists and then distributed into EDTA, serum and citrate vacutainer tubes, and into tubes designed for RNA preservation (Tempus tube). Fasting glucose, and cholesterol are measured by point of care tests. An Oral Glucose Tolerance Test is carried out in a subset of participants, enabling validation of diabetes classification. A spot urine sample (10ml) is also collected for analysis of albuminuria and other biomarkers. Aliquots of whole blood, buffy coat, serum, EDTA plasma, citrate plasma, and urine are being stored at -80? for future molecular epidemiological research (including genomics) to investigate the mechanisms underpinning the development of T2DM and CVD, and other complex diseases that are of importance to South Asians (including but not limited to: obesity, cancer, dementia, COPD, chronic kidney disease). The laboratory providing HbA1c assays is Asiri Hospital Holdings PLC

Global metabolite profiling, sodium and potassium profiles will be obtained through a subsample of adults’ urine collection in the intervention and control groups. This indicator will be obtained to validate the dietary intake assessment using Intake-24. A single-timed 24-hour urine collection will be obtained for estimation of global metabolite profiling. Instructions on urine collection will be provided. All participants will be invited to discard the overnight urine to start the urine collection period with an empty bladder. Morning sample will be collected, stored in a refrigerator, and labelled in rimmed polypropylene bottles. Physical activity is quantified by an Axivity AX3 wrist-worn triaxial accelerometer, worn on participants’ wrist for seven days (dominant arm). This device is small, light-weight, wrist-watch shaped, battery-powered and uses triaxial accelerometry to infer participant movement. It has been recently used to measure physical activity patterns amongst 100,000 people in the UK Biobank study.

Dietary intake. Intake24 (https://intake24.org/) is a digital system to collect dietary intake information, based on the multiple-pass recall method. Participants are asked (via interviewer for SAB) to recall what they have eaten and drunk in the past 24 hours. Individual foods/drinks are entered in the search box and participants are asked to find and select the best match for their food in the list of foods in the database within Intake24. Portion size is estimated for each food/drink recorded using a number of approaches including food photos: as served and guide images, drink scales and standard measures. The tool includes prompt questions to probe for detail including foods that are commonly underreported. The tool includes a function for participants to report their food as a ‘missing food’ if they cannot find it in the food database. Intake data collected needs to be quality checked and processed to finalise. ‘Missing foods’ require manual coding. The administered questionnaires are translated into locally relevant languages and supported by graphics representations to facilitate collection of high-quality data (Annex

(a) age 18+ years (b) male or female (c) South Asian ancestry (d) permanent resident of the surveillance site (resident for >12 months).

(a) planning to leave the study site within the next 12 months (b) cancer or other serious illness expected to reduce life expectancy to less than 12 months