Study Methodology

Study Aim

Study Design

Study Sites

Inclusion and Exclusion Criteria

Sample Size

Proposed outcomes

Intervention

Study Variables

Ethical approval

Aim of the study

To design, develop and pilot test an interactive, tailored, internet and mobile enabled digital health intervention to enhance self-management of MetS among individuals living in urban poor settings.

Objectives of the Study

 Objective 1
To develop a model that examines cardio-metabolic risk factors such as diet and physical activity, stress and sleep and its interplay with the living environment in facilitating self-management of MetS among adults living in urban poor settings of New Delhi.
 Objective 2
To design and develop an interactive digital health intervention to enhance self-management of MetS based on the findings of Aim one.
 Objective 3
To pilot test the utility and feasibility of the proposed digital health intervention platform among adults living in urban poor settings to help them self-manage their MetS.

Mixed methods(Qualitative and quantitative research method)

To achieve objective one, a mixed-method approach combining qualitative and quantitative assessments will be utilised to create a model that describes the interaction between the living environment and other cardio-metabolic risk variables such as nutrition, physical activity, stress, and sleep. The focus group talks and in-depth interviews will take place among a sample population of 120 participants drawn from distinct urban slum settings in four zones of New Delhi.

To achieve objective two, a quasi-experimental study design will be used in a sample of 80 participants, with a human-centered approach to design and develop an interactive, tailored mobile and internet-enabled digital health intervention platform aimed at supporting self- management among individuals living with MetS in urban poor settings. The findings of objective one will help in defining the essential elements/modules and features of the proposed digital health intervention platform.

A sample size of 30 people from each of the eight slums (240 participants) will be used to pilot test the utility and feasibility of the proposed digital health intervention in an urban poor community setting in New Delhi (areas including North, South, East, West, and Central zones of New Delhi) to measure usage, adherence, satisfaction, and acceptance with the proposed digital health intervention platform

West Zone

Khazan Basti, Mayapuri
Udyog Nagar, Peeragarhi

East Zone

Ambedkar Camp, Kalyanpuri
Indira Camp, Kalyanpuri

North Zone

A Block, Shalimar Bagh
Shaheed Udham Singh Park, Wazirpur Industrial Area

South Zone

Kusumpur Pahari, Vasant Vihar
Bhanwar Singh Camp, Vasant Vihar

Objective 1 120 participants (15 participants from eight slums each)
Objective 2 80 participants (10 paticipants from eight slums each)
Objective 3 240 participants (30 participants from eight slums)

Socio-demographic profile.

Data regarding age, income levels, employment status, education level, smoking, and alcohol status. Information gathered about prior use of computers, their frequency of usage, prior use of the internet, and sources of health information are captured.

Medical history

Medical history of the participant such as history of identified NCDs, medications used and such will be assessed.

Laboratory Assessment

Assessment of blood sugar, HbA1C, and blood pressure levels

Anthropometry

Height, weight, and waist circumference, Body Mass Index

Dietary assessments

24 hour Dietary recall:A standard technique will be used to examine the preceding 24 hours’ dietary consumption.The methodology will incorporate visual aids (models of portions/serving sizes) to help respondents avoid false food consumption reporting.
Dietary Diversity:The FAO’s Individual Dietary Diversity Score (IDDS) instrument will be used to examine diversity in individual participants’ diets. The tool comprises 16 food groups, nine of which will be analysed. Diets consisting of three food groups are classified as low diversity, diets consisting of four to five food groups are classified as moderate diversity, and diets consisting of more than six food groups are classified as high diversity.

Perceived Stress Scale

The Perceived Stress Scale (PSS) is the most commonly used psychological instrument for assessing stress perception. It is a measure of how stressful conditions are perceived to be.

Physical activity assessment

The Global Physical Activity Questionnaire will be used to assess participants’ physical activity (GPAQ). The questionnaire will determine the total time spent in physical activity for recreation, occupation, household work, and transportation.

The Pittsburgh Sleep Quality Index

The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire that will be used to evaluate sleep quality and disruptions during a one-month period. There are seven “component” scores generated by 19 individual items: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disruptions, usage of sleeping medication, and daytime dysfunction. The sum of these seven components’ scores provides one overall score.

Health Knowledge, Attitude, and Practice Assessment

The data is assessed based on MetS knowledge, risk factors for Co-morbidities, attitude toward health-related choices, and practise patterns. The KAP evaluations are an educational tool that will evolve throughout time. The assessment used at various time points can aid in identifying major changes and the consequences of the intervention.

Morisky scale of Medical Adherence

The Morisky Scale for Medical Adherence is a brief evaluation based on patient replies. These tools examine the mindset underlying adherence, the barriers to adherence, and the convenience or simplicity of medicine, which is a significant element of adherence.

The Summary of Diabetes Self-Care Activities

The revised version of the summary diabetes and hypertension self-care activities questionnaire will be used to collect information on self-care activities among diabetic patients (SDSCA). The key questionnaire components will be evaluated, along with a few additional questions on each component and pharmaceutical practices.

Satisfaction to digital health intervention platform

The CSQ-Client Satisfaction Questionnaire-8 question will be used to assess it. This eight-item questionnaire provides a self-report evaluation of the intervention platform.

System Usability Scale (SUS)

The SUS questionnaire evaluates the applicability of the application functionality and the usability of the digital health intervention. It also examines how much users regard the programme as a support for their goals and duties, as well as the usability of the interfaces.

“The Indian Council of Medical Research-National Institute of Pathology Institutional Human Ethics Committee approved the study in January 2022, with approval number NIP-IEC/29-12-2021/05/01R1.The study will be carried out in accordance with the Helsinki Declaration.”