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About the study:

The Mumbai Cohort Study (MCS) was the first large study to employ house-to-house recruitment as well as follow-up using hand-held computers. The study not only demonstrated successful methods to conduct large cohort studies in low-resource countries but ensured very high response rate (~95% after an average 5.5 years of follow-up). The study was conducted with the aim to study the diversity and socio-demographic characteristics of tobacco use in Mumbai, India. The study reported for the first time about the excess all-cause and cause-specific mortality from various forms of tobacco use other than cigarette smoking. The study concluded for the first time that bidi smoking is no less hazardous than cigarette smoking, and smokeless tobacco use may also result in significantly increased mortality.

The cross-sectional data were also used to study association of different exposures with the self reported health outcomes such as TB and diabetes. Using MCS cross-sectional data we have successfully demonstrated the feasibility of linking Population Based Cancer Registry (PBCR) data with MCS data and studied the association of tobacco habits with overall and site specific cancer incidence in Mumbai.

Type of study:

Prospective Cohort Study

Timeline:

Started1999 - second follow up ended - 2018

Principal Investigators:

Dr. Prakash C. Gupta / Dr. Mangesh Pednekar

Study Participants:

1,50,000 individuals aged > or =35 years were recruited in Mumbai, India in years 1991-1997 and have been followed up since then.

Publications:

About the study:

This study was done to perform a case-control analysis to test the hypothesis that candidate SNPs are associated with increased BcCA risk and that subjects with both poor (pro-inflammatory, high-fat) diets and candidate risk genotypes have even greater BrCA risks compared to subjects without a risk allele and with more healthy diets.

Type of study:

Genetic and Dietary Case-Control study of Breast Cancer

Timeline:

2009-2013

Collaborators:

Arnold School of public Health, Tata Memorial Hospital and Healis – Sekhsaria Institute for Public Health.

Principal Investigator:

Dr. Jim Burch, James Herbert (Co-investigator), Susan E. Steck (Co-investigator), Dr. Rajiv Sarin (Co-investigator), Dr. P.C. Gupta (Co-investigator)

Study Participants:

Altogether, we had 2357 diet forms (FFQs) received, coded and shared from ACTREC so far with the team. Details of the Food frequency questionnaires are as follows:

BGSC (Sporadic Cases) -1183
BGFC (Familial Cases) -064
BGSN (Sporadic Normal) -1086
BGFN (Familial Normal) -024

Publications:

About the study:

This is a consortium of Cohorts in Asia conducting joint analysis that includes over million individuals. Mumbai Cohort study data are contributed to this Consortium.

Type of study:

Meta-analysis of Cohort Studies

Project Website:

www.asiacohort.org

Publications:

About the study:

The broad objective of the TCP India Project is to evaluate and understand the prevalence and patterns of tobacco use and impact of tobacco control policies of the Framework Convention on Tobacco Control (FCTC) as they are implemented in low- and middle-income countries (LMICs) participating in the International Tobacco Control Policy Evaluation Project (the ITC Project).
Note: The name Tobacco Control Project (TCP) is used in reference to the India Project instead of International Tobacco Control (ITC) Project, used with other countries, because in India the abbreviation ITC also refers to the Indian Tobacco Company.

Type of study:

Longitudinal cohort study

Timeline:

01 Feb, 2017 to 31 Dec, 2021

Collaborators:

University of Waterloo, Canada

Study Participants:

A total of 2000 tobacco users and 600 non-users from urban and rural population sample were selected from each of the four states of Maharashtra, Madhya Pradesh, West Bengal and Bihar for the study. Wave 1 and Wave 2 of the TCP India project have already been executed. As a follow-up, in Wave 3 re-contact of participants recruited in previous waves across these four states have been done.

Principal Investigators:

Dr. Mangesh S Pednekar, Dr. Geoffrey T. Fong

Co-Investigator-

Dr. Prakash C. Gupta

Publications:

• Intention to quit among Indian tobacco users: findings from international tobacco control policy evaluation India pilot survey.

• Awareness of pro tobacco advertising, promoting, and beliefs about tobacco use: findings from the tobacco control policy (TCP) India pilot survey.

• Quit history, intentions to quit, and reasons for considering quitting among tobacco users in India: findings from the tobacco control policy evaluation India wave 1 survey.

• The relation between price and daily consumption of cigarettes and bidis: findings from the tobacco control policy evaluation wave 1 survey.

• Social impacts on adult use of tobacco: findings from the international tobacco control project India, wave 1 survey.

• An examination of the effectiveness of health warning labels on smokeless tobacco products in four states in India: findings from the TCP India cohort survey

Current Status:

As of September 2022
• Press conference on “Tobacco Control Policy Evaluation Project” was conducted on May 30, 2022.

•Technical report for Wave 3 data set is been finalized.

About the study:

This study aims to prospectively measure Community Tobacco Environmental (CTE) factors (i.e., objective assessments of community level compliance with tobacco control laws, availability of all forms of tobacco products including gutkha and e-cigarettes, and the presence of tobacco vendors and advertisements). The study will also estimate whether CTE factors are longitudinally associated with adolescent tobacco use initiation and trajectories

Type of study:

Longitudinal Cohort study extending over a period of five years

Timeline:

August 2016-December 2021

Collaborators:

1)University of Michigan, USA
2)University of California (UCLA), Los Angeles, Fielding School of Public Health, USA

Principal Investigators:

Dr. Mangesh S Pednekar, Dr. Ritesh Mistry.

Co-Investigators:

Dr. Prakash C. Gupta, Dr. William McCarthy, Prof. Trivellore Raghunathan,
Dr. Namrata Puntambekar.

Study Participants:

Approximately 2000 adolescents and their parents will be surveyed and followed up over a period of four years in two cities in India- Mumbai and Kolkata.

Publications:

Longitudinal study of adolescent tobacco use and tobacco control policies in India.

Neighbourhood tobacco retail access and tobacco use susceptibility in young adolescents in urban India.

Family functioning within the context of families with adolescent children in urban India.

Current Status:

As of September 2022
• Wave 3 data collection is completed and currently working on developing survey tools for Wave 4.
• All the tools (consent, scripts, and questionnaire) for Wave 4 have been finalized in all the languages (English, Hindi, Marathi, and Bengali).
• Community mapping has been completed in all the areas in Mumbai and Kolkata.

About the study:

Epidemiological overview:

According to World Health Organization (WHO), by 2030, more than 8 million people globally are expected to die from tobacco-related causes, 80% of whom will be from LMICs. In India in 2010 alone, an estimated 930,000 people died from smoking, and in 2008, an additional 368,000 deaths were attributed to smokeless tobacco use, illustrating the complex effects of the use of multiple forms of tobacco. Reflecting these trends, India has one of the highest oral cancer rates in the world. In 2010, the prevalence of tobacco use among men in India was 48% and among women was 20%.

Context and Problem Statement:

The National Cancer Institute (USA) formed its Center for Global Health aimed at reducing the global burden of cancer. Although India was an early signatory to the Framework Convention on Tobacco Control, few resources were available to support tobacco use cessation, the prevalence of quitting was low and, few social norms supported quitting. Ensuring the availability of adequate evidence and making use of available evidence to respond by pressing public health issues, particularly in light of the lag time between efficacy/effectiveness research and implementation of evidence-based intervention in practice.

Study objective:

To identify effective strategies for broad-based implementation of the evidence-based tobacco control intervention (tested in schools of Bihar) that could be embedded in existing organizational infrastructures and could accommodate the realities of low-resource settings. The study was implemented in schools in Bihar.

Research Question:

To achieve this objective our central research question was: will this evidence-based intervention be successfully adopted, implemented, and maintained through existing channels using the proposed implementation model?


Accordingly, the Specific aims of the study are:

Aim 1.

Determine the extent to which this implementation model meets acceptable rates of program adoption, implementation, and reach of the program among schools in Bihar.

Approach:

In India, the education system is structured hierarchically, with schools nested within clusters, clusters within blocks, and blocks within districts. The dissemination of new curricula typically follows a cascade model, progressing through this nested structure. For this study, we leveraged this existing framework by training cluster coordinators—those responsible for curriculum training—to build the capacity of school principals to implement and maintain the TFT-TFS program effectively using the Trainings-of-Trainers strategy. Cluster coordinators were trained to provide ongoing training, guidance, and support to school principals throughout the implementation phase.

Methodology:

A randomized control trial (RCT) design was employed. After securing the support letter from three districts, selected two blocks from each of the three districts and randomly assigned one block per district to the intervention and control arm. A total of 219 school headmasters from 46 clusters within three blocks of the intervention arm were trained by 46 cluster coordinators at their respective cluster resource centers. Trained headmasters or designees implemented the TFT-TFS program in their schools.

Outcome:

The implementation model was adopted and implemented in the schools of Bihar and Headmasters were trained.

Aim 2.

Determine program effectiveness in increasing the implementation of tobacco control policies and in promoting tobacco use cessation in schools.

Approach:

To assess program effectiveness in improving tobacco policy implementation, increasing tobacco use cessation, and monitoring secular trends in tobacco control, we conducted two evaluation visits: one before and one after program implementation. These visits were complemented by surveys administered to headmasters and school personnel, as well as the use of standardized observation checklists within the schools.

Methodology:

For assessing the effectiveness of the intervention activities, 70 schools were randomly selected from a total of 219 schools in the intervention block, and 70 schools were randomly selected from 224 schools in the control blocks. This gave us a sample size of 429 teachers from intervention schools and 331 teachers from control schools. Surveys and observation checklists were standardized, using validated instruments designed to measure both the implementation of tobacco control policies and tobacco use cessation efforts. Baseline data was collected before the intervention to compare pre-and post-implementation outcomes.

Outcome:

The program was effective in increasing the implementation of tobacco control policies.

Aim 3.

Determine the feasibility of building the capacity of cluster coordinators to train and support principals in program implementation and maintenance in schools, and for the DoE to sustain the program.

Approach:

After analyzing post-maintenance data, a state-wide meeting was hosted with the Department of Education (DoE) to orient district officers in Bihar on implementing the program in their districts. Key informant interviews were conducted with DoE leadership to assess sustainability plans.

Methodology:

Over years 2-4, regular consultation meetings were held with DoE to review the implementation and maintenance of the TFT-TFS program in schools. Findings were used to refine the implementation model and develop a sustainability plan, which included: • Leadership support by aligning the program with DoE priorities. • Integration of training and technical assistance roles into DoE job descriptions and performance metrics. • Resource allocation, budgeting, and cost-effective production of program materials. • Monitoring and evaluation by using DoE's existing tracking systems to evaluate the program over time. Collaboration with DoE to ensure maintenance strategies and embed responsibilities into existing DoE roles.

Outcome:

A self-help guide for implementing the TFT-TFS program was developed and disseminated to 25,000 schools in Bihar. An assessment of dissemination in 12 blocks from 6 districts showed that 96% of headmasters received soft copies of the guide

Type of Study:

Intervention dissemination.

Study Participants:

Headmasters and school teachers.

Study Timeline:

January 2017- 31st December 2023

Collaborators:

Dana-Farber Cancer Institute & Harvard School of Public Health, USA
Centre for Health Decision Science, Harvard School of Public Health, USA.

Principal Investigators:

Dr. Prakash C. Gupta, Dr. Glorian Sorensen

Co-Investigators:

Dr. Mangesh S. Pednekar, Dr. Eve M. Nagler, Dr. K. Viswanath, Dr. Harry A. Lando, Dr. Jane Kim, Dr. Dhirendra N. Sinha

Publications:

1. Gupta, Prakash C., et al. "Upscaling a behavioural intervention program for tobacco use cessation–A randomised controlled study." Preventive Medicine Reports 36 (2023): 102476. 2. Gupta, Prakash. "Involving School Teachers in Tobacco Control: A Story from Bihar." India, Century Publications, 2023, pp. 47–53. 3. Nagler, Eve M., et al. "Implementation of an evidence-based tobacco control intervention for school teachers in India: Evaluating the effects of a capacity-building strategy." Implementation Research and Practice 4 (2023): 26334895231159428. 4. Nagler, E. M., et al. "Factors associated with successful tobacco use cessation among teachers in Bihar state, India: a mixed-method study." Health education research 35.1 (2020): 60-73. 5. Pednekar, M. S., et al. "Scaling up a tobacco control intervention in low resource settings: a case example for school teachers in India." Health Education Research 33.3 (2018): 218-231.

Dissemination:

The dissemination of a self-help guide for implementing the TFT-TFS intervention in Bihar and Maharashtra was published and released in regional languages during a press conference.

Current Status: July 2024- December 2024

Completed project: Data analysis and manuscript under preparation.

About the study:

This study investigates the relationship between carcinogen content in smokeless tobacco (SLT) products and relevant exposures as well as oral/head and neck cancer (OHNC) risk in users of these products, while concurrently building capacity for a sustainable tobacco carcinogenesis research program in India.

Type of study:

Laboratory Epidemiology

Timeline:

August 2017- July 2022

Collaborators:

Department of Otolaryngology, University of Minnesota, US
Masonic Cancer Center, US
Tata Memorial Hospital, India
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Navi Mumbai, India

Principal Investigators:

Dr. Samir S. Khariwala, Dr. Irina Stepanov, Dr. Pankaj Chaturvedi

Co- Investigators:

Dr. Prakash C. Gupta, Dr. Vikram Gota, Dr. Dorothy Hatsukami, Dr. Saonli Basu

Publications:

Observed Circumvention of the Gutka Smokeless Tobacco Ban in Mumbai, India.

Study Participants:

Patients with oral head and neck cancer and healthy smokeless tobacco users.

Current Status:

As of September 2022
• The web portal has been designed and is currently under preparation -which will display all necessary project information on the Healis website.
• A smokeless tobacco review paper has been drafted and circulated with the full team for review.
• Continued storage of tobacco product samples obtained from recruited patients as well as smokeless products collected as a part of the repository.
• Paper under process titled “The urgent need for product regulation and public education to reign in the deadly toll of smokeless tobacco in India.”

About the study:

The study aims to measure the effectiveness of a worksite multi-component environmental intervention to reduce cardiometabolic risk in India and to evaluate the process outcomes. As an important way to translate CVD prevention efforts, worksite interventions can facilitate healthy food choices, health education, and social support.

Type of study:

Behavioural Qualitative Intervention

Timeline:

June 2019- March 2022

Collaborators:

Yale School of Public Health, USA
Durban University of Technology, South Africa

Principal Investigators:

Dr. Mangesh S. Pednekar, Dr. Donna Spiegelman

Co-Investigators:

Dr. Prakash C. Gupta, Dr. Ashika Naicker

Study Participants:

Permanent/Contractual worksite employees

Current Status:

As of September 2022
Following Intervention material finalized :
• Canteen and behavioural intervention (CB)
1. Diet and physical activity diary.
2. PowerPoint presentations of the intervention session.
3. Session handouts- pamphlets
4. Pre and Post survey
5. Session feedback forms.
6. Dietary inflammatory index (DII) questionnaire.

• Canteen intervention only (CO)
1. Posters.
2. Standardized tea recipe.
3. Healthy breakfast option list.
4. Traffic color-coded canteen breakfast menu
5. Calorie intake and minutes of brisk walking.
6. Sprout salad recipe (100 servings)

About the study:

The main objective of the study is to examine the perceived effectiveness of the text warning on areca nut products and compare them with mandated pictorial warning labels on smokeless tobacco products.

Type of study:

Cross-sectional Study

Timeline:

Jan 01, 2022 to Dec 31, 2022

Collaborators:

Indian Council of Medical Research (ICMR)

Principal Investigators:

Dr. Namrata Puntambekar

Co- Investigators:

Dr. Prakash C. Gupta, Dr. Mangesh S. Pednekar

Study Participants:

18 years and above (only participants from Mumbai city)

Current Status:

As of September 2022
Following work has been completed in the past six months:
• Required assets have been purchased for the project
• Preparation of the script for the survey
• Preparation of the consent form
• Preparation of the training manual for field investigators
• Preparation of the sampled areas to conduct the fieldwork and drew the boundaries
• Preparation of the household enumeration form for the survey.

About the study:

To study the knowledge, attitude, beliefs and factors related to COVID-19 vaccination hesitancy across Maharashtra.

Type of study:

Cross-sectional Study

Timeline:

Dec 01, 2021 to Aug 31, 2022

Collaborators:

None

Principal Investigators:

Dr. Khushbu Sharma

Co- Investigators:

Dr. Rupesh Mahajan, Dr. Mangesh S. Pednekar, Dr. Prakash C. Gupta, Mr. Sameer Narake

Study Participants:

18 years and above (only participants from Maharashtra state)

Current Status:

As of September 2022
• Data cleaning procedures were carried out and final data set for data analysis was prepared.
• A total of 1102 participants had accessed the survey link and the final number for analysis is 873 participants.