Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India
Phase: NA
Conditions: Diabetes, Heart Disease, Obesity
Sponsor: Emory University

Study Protocol
Title: Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India 
 Date 3/31/2023 
NCT02813668

Specific Aims 
Diabetes has reached epidemic proportions globally; some countries, like India, are acutely affected. At 
least 65.1 million people in India have diabetes and a further 77.2 million have prediabetes, many of whom are 
working age adults.1,2 Diabetes has profound implications for health systems (personnel and resources to 
provide care), individual and family finances (high costs of care particularly where insurance does not exist, 
loss of wages due to lost work time), individuals (debilitating secondary complications, lower quality of life, 
shorter life expectancy), and worksites (lower productivity, greater lost work time).1,3-5
Data from randomized controlled trials unequivocally show that lifestyle modification reduces diabetes 
incidence in people with prediabetes, improves glycemic control and cardiovascular risk profiles, and has 
beneficial effects on diabetes complications;6-17 however, community-based implementation of these programs 
is challenging because they are costly and require large commitments of staff and participant time.18 
Translation to the broader population will require creative solutions to lower financial and personnel costs, and 
these programs need to be delivered in a way that is acceptable and accessible, cost-effective for payers, 
culturally appropriate, and easy to disseminate and maintain. Delivering lifestyle programs at worksites, using 
the existing structure of worksite health facilities for testing and training and utilizing trained worksite staff as 
peer health educators, could be an effective and cost-effective approach for delivering lifestyle education, may 
overcome many individual-level barriers to participation in a lifestyle education program (e.g., lack of time and 
social support, inability to locate resources), and could be beneficial to employers (e.g., higher employee 
satisfaction, retention, and possibly less lost productivity due to illness).19-24
Members of the research team proposing this work have developed and tested a successful model of 
lifestyle education for use in India (D-CLIP, Diabetes Community Lifestyle Improvement Program25) and have 
conducted many studies in India and elsewhere which have shown positive health effects of improving diet 
quality.26-40 Building on this research, we propose implementing and evaluating the acceptability, delivery, 
effectiveness, and cost-effectiveness of a worksite-based lifestyle improvement package: a peer-led lifestyle 
change program with group-based classes on weight loss/maintenance, dietary improvements and increasing 
physical activity delivered in worksite environments that facilitate these changes (for example, by offering 
healthy food options in the canteen). Since the evidence unequivocally shows that lifestyle change is 
efficacious and essential for diabetes prevention and management and is already part of authoritative 
guidelines41 and given that this is an implementation trial that could result in the subsequent scale-up of efforts, 
we propose using a pre-post trial design to assess if the intervention package can prevent diabetes and 
cardiovascular disease risk factors in adults with prediabetes (HbA1c of 5.7-6.4%) or unmedicated diabetes 
(HbA1c ≥ 6.5%, but currently not taking diabetes medications) in India. Among 2000 people with prediabetes or 
early diabetes identified from eight diverse worksites in India with stakeholder commitment, we will use a mixed 
methods approach to evaluate a worksite-based, culturally tailored intervention package. The study aims: 
Aim 1: To measure the success of implementation and inform the scalability of this intervention program by 
evaluating: (a) program adoption by assessing participation and changes in weight and diet and physical 
activity behaviors among lifestyle class participants; (b) fidelity to the program by assessing activities of study-
affiliated worksite staff; changes to the food options at the worksite canteen; management support for the 
program; and changes in the worksite environment; and (c) acceptability of the program through (i) in-depth, 
semi-structured interviews with study site management and employees and lifestyle education program 
dropouts and (ii) focus group discussions with lifestyle education program participants.
Aim 2: To measure the effectiveness of the program among participants by evaluating the change in number 
of individuals reaching two or more of cardiometabolic risk goals, namely reductions in blood pressure, 
triglycerides, and HbA1c (the primary outcome), and through changes in secondary outcomes including rates of 
diabetes incidence and regression to normoglycemia and changes in anthropometry, lipids, and fasting 
glucose.
Aim 3: To measure the value and return on investment of the intervention for employers by assessing program 
cost and cost-effectiveness and changes in staff productivity, absenteeism, health status, and quality of life.
If the program is shown to be feasible, acceptable, effective, and cost-effective at these worksites, the 
results of this study will be used to make recommendations and dissemination plans on how to implement and 
sustain lifestyle interventions at worksites to improve the health of workers and communities for other sites 
within these companies, other Indian worksites, organizations involved in promoting worksite wellness and/or 
chronic disease prevention, and to India’s National Programme for Prevention and Control of Diabetes, 
Cardiovascular Diseases, and Stroke. Furthermore, lessons from this study can be used to make 
recommendations or plan studies of similar worksite programs in the U.S. and other settings outside of India.

Significance
The Diabetes Epidemic: Type 2 diabetes mellitus (T2DM) is an economically costly disease and a major 
cause of morbidity and mortality globally.4,42 Eighty percent of the 382 million people worldwide with diabetes 
live in low- and middle-income countries.1 Asian Indians living worldwide are particularly susceptible to 
developing T2DM, with high prevalences of T2DM and T2DM risk factors (e.g., beta-cell dysfunction, central 
adiposity), higher rates of progression from prediabetes to diabetes,43 and lifestyles that pre-dispose to T2DM 
(e.g., high-fat, low fiber diets and low physical activity).2,44-46 Asian Indians fare worse than several other 
populations after developing T2DM (poor glycemic control, higher rates of complications).47-50 
Lifestyle and Diabetes and Cardiovascular Disease (CVD) Risk Factors: Lifestyle intervention participants in 
the multi-center, U.S. Diabetes Prevention Program (DPP) had a 58% reduction in diabetes incidence 
compared to controls, with results consistent across race-ethnicity, sex, and age.14 In the DPP and other 
similar studies, lifestyle change was shown to have lasting effects, with significant improvements subsisting 3-
14 years after the intervention.9,11,12,51 The Look AHEAD study, which assessed the effectiveness of a lifestyle 
intervention program for preventing CVD endpoints in individuals with diabetes, showed that intervention 
participants did significantly better than controls in terms of weight loss and reductions in CVD risk factors, 
required less medications to manage blood pressure and lipid levels, and had a greater remission to 
normoglycemia than controls.17,52,53 Lifestyle interventions have beneficial effects on other cardiometabolic risk 
factors, including low physical activity, poorly controlled blood pressure and plasma lipids, and on incidence of 
retinopathy, chronic kidney disease, urinary incontinence, and disability.8,13-16
Improving diet quality is an important component of lifestyle interventions, particularly given the negative 
health impacts of shifting from diets high in fresh produce and whole grains to diets high in refined 
carbohydrates and added sugars.28,30 High quality diets (e.g., low in trans fats and glycemic load and high in 
fiber) decrease the risk for diabetes38,54-57 and are important for maintaining glucose control and reducing CVD 
risk among individuals with diabetes.58,59 Simply substituting brown rice for white rice as a staple food item 
significantly reduces fasting glucose and insulin levels.40 Lack of awareness of health benefits, texture, 
palatability, scarcity, and cost are barriers to consumption of whole grains but promoting health benefits and 
subsidies to reduce cost are strategies that might increase consumption.27,31,34,60,61 
Diabetes Prevention at the Worksite: People with diabetes have twice the rate of premature retirement than 
the rest of the population and compared to their peers without diabetes, are more likely to be unemployed, take 
more sick days, and report more work limitations.62,63 These factors affect the overall productivity of worksites 
and lead to losses in profits for companies;62 therefore, preventing diabetes and diabetes-related complications 
can be economically advantageous for companies.24 
Worksite-based interventions can overcome barriers to healthy lifestyle choices by providing resources at a 
place and time where individuals spend much of their week and a socially supportive environment for change. 
Worksite-based health promotion programs have shown positive impacts on employees and worksites; a meta-
analysis19 of worksite-based physical activity programs reported that participants showed significant positive 
improvements in cardiometabolic risk factors (e.g., fitness, adiposity, and fasting glucose) and lower 
absenteeism and job stress and a worksite-based education program to improve employee diets resulted in 
significant improvements in diet quality.20,64 Worksite wellness programs and intervention programs targeting 
diabetes prevention and weight loss have also shown positive effects on both mental (increased feelings of 
calmness, happiness, and ability to cope with stress) and physical (improvements in diet and physical activity 
behaviors, aerobic fitness, anthropometry, blood pressure, lipid profiles, plasma glucose) health.21-23 The 
effects of these studies can be lasting, with one trial noting that risk factor improvements still persisted two 
years after intervention delivery.22,23 In another study, even though health-related impact decreased over the 
seven years of follow-up, employee retention remained better among intervention participants.65
Worksite-based programs must address both individual health behaviors and the work environment.66,67 In a 
recent review, screenings and health assessments, environmental changes to support the intervention (e.g., 
low-cost healthy food choices, places for physical activity), and group-based health education classes were 
specified as components of successful worksite interventions.24 Management support has been shown to be 
highly influential in terms of the effectiveness of health programs in a number of settings,68 and worksites with 
a staff person dedicated to delivering health education were 10.3 times more likely than other worksites to 
have comprehensive health promotion programs.66
 Delivering lifestyle education in workplaces with a focus on improving the worksite environment, 
collaborating with management, and training peers as health educators would be an innovative way to scale 

and translate diabetes and CVD prevention efforts. This research team has considerable experience in 
translational research and lifestyle education and change in India.25,27,28,32,33,37,40,69 Building on this 
experience, we propose conducting a pre-post implementation trial to assess the acceptability, feasibility, and 
impact of a worksite-based lifestyle education program taught by trained peer educators and supplemented 
with changes in the worksite environment (e.g., offering healthy options in the work canteen, creating a 
supportive climate for lifestyle class participation) for employees with prediabetes and diabetes at eight 
worksites in India. This project will use a mixed methods approach to assess the intervention and its 
implementation, enabling well-supported recommendations for sustaining and implementing this intervention. 
Innovation 
We propose to implement and test a worksite-based lifestyle education program focusing on weight loss, 
dietary improvement, and increasing physical activity to individuals at risk of diabetes and/or CVD at eight diverse 
worksites in India (see Letters of Support). Integrated innovation theory posits that in order for an intervention to 
be successful in complex situations (e.g., the community), it must integrate scientific/technological, social, and 
business innovations.70 This project fulfills this requirement: It delivers scientific innovations (lifestyle education 
programs with text message supports during maintenance) with social innovations (trained peer health educators 
delivering a program to a large at risk population) and business innovation (worksite stakeholder commitment 
and partnering researchers to help deliver the program with fidelity, improve the workplace health environment, 
and evaluate the model). The packaging of lifestyle education with environmental changes at the worksite level, 
implemented through an academic-industry partnership, is rarely done, particularly in India, a population with 
acutely high risk for diabetes and diabetes-related complications, and if successful could provide a model for 
innovative delivery of lifestyle education. 
The lifestyle curriculum will be based on the program developed for the D-CLIP study,25 a randomized 
translational trial of lifestyle modification delivered to community members at a diabetes care clinic in India. 
Recommendations for dietary quality improvements will also build on research conducted by members of the 
study team.26-40 Applying this knowledge at the worksite represents the movement from clinic-based 
translational work to the broader community and allows the scaling of the intervention program from a single 
site, focused population to multiple locations and broader populations. Furthermore, delivering a diabetes 
prevention program at worksites in India at no cost to the employee can overcome many of the barriers to 
lifestyle change (e.g., cost of classes, lack of time, inability to locate acceptable resources for weight loss) and 
worksite support of the program might be a source of motivation for participants. 
The intervention will include a broader range of individuals [selected by glycated hemoglobin (HbA1c) testing] 
who could benefit from lifestyle change than have been included in previous translational research studies, 
namely both individuals with prediabetes and those with unmedicated diabetes. This population represents the 
larger community of individuals at risk of developing diabetes-related outcomes and complications. 
This innovative worksite-based program leverages existing worksite resources (space, health facilities, 
employees) to deliver the intervention package, which includes lifestyle intervention classes and broader 
changes in the worksite environment. Peer educators, identified from the worksite and trained by professional 
health educators to deliver the program, can assist in sustaining the program, offer practical suggestions for 
program improvement and overcoming participant barriers, and act as examples for their peers. Classes will be 
dynamic and group-based, including scripted lessons on health topics (to maintain fidelity to the message 
across sites) followed by group-based activities and discussions that can be tailored to the individual needs of 
each lifestyle class and worksite. The program will include four months of weekly classes on weight loss, diet 
improvement, increasing physical activity, and behavior change followed by an eight-month maintenance 
period with monthly group meetings, biweekly health related text messages, and continued support of the 
health education teams. The work environment will be supportive of these changes with management advising 
and promoting the program, allowing staff time to participate, providing staff as health educators, allowing 
space for classes, testing, and other study activities, covering some of the costs of testing, and making 
changes in canteen food offerings to adhere to the recommendations of the program. 
The program evaluation will use mixed methods techniques to assess program acceptability, impact, and 
effectiveness. Although the goal of the program is to benefit employees, the program evaluation includes 
measures such as cost-effectiveness, changes in employee absenteeism/presenteeism and qualitative 
assessments of employee views of the program that will be beneficial to employers using or considering this 
program for their worksite. In addition, the acceptability and impact of the program will be measured from the 
perspective of multiple stakeholders – program users, employees at the worksite, and worksite management. 
Understanding the program outcomes and acceptability from these multiple perspectives will provide rich data 
for making recommendations for sustaining and disseminating the program.  

Although this study will be conducted in India, the results will be applicable to workers in other settings, 
including the U.S. (see Foreign Justification). Asians, including Asian Indians, are the fasting growing ethnic 
group in the U.S., and between 2000 and 2010 the Asian Indian population increased by 67.6%.71 Furthermore, 
several of the companies committed to this trial (the TATA group, L&T, and Cognizant) have locations 
worldwide, including offices in America, and these sites would be ideal locations for first phase dissemination. 
In addition, lessons learned in this study would benefit U.S. companies with worksites in India. 
Approach 
This study will use a pre-post design at eight diverse worksites to assess program implementation, fidelity, 
effectiveness, and impact on study participants, workers, and the worksite. There will be no control group 
because there is already convincing evidence from randomized trials8,9,17,53,58,72 that lifestyle intervention is 
beneficial for preventing diabetes and diabetes-related complications. Although randomized controlled trials 
provide the most robust evidence for effectiveness, meta-analyses have shown that the results of non-
randomized, effectiveness studies do not systematically differ from the results given by randomized controlled 
trials of the same treatment.73,74 
Intervention
The lifestyle intervention will be conducted at eight worksites (see Table 1). These worksites have large 
workforces (1,500-50,000 employees) and represent a range of industries with locations across India. An 
overview of activities to be conducted at each worksite are shown in Figure 1. 
Table 1: Demographic Overview of Study Sites
Company name
Location
Type of Industry
Number of 
Employees
Employee 
Age-range
Percent 
Women
Chennai Petroleum Corporation Ltd
Chennai
Oil Refinery
1,500
30-55
1-2%
L&T Infotech
Chennai
Technology and Business Services
3-5,000
20-50
30-35%
Cognizant Technology Solutions 
Chennai
Technology and Business Services
50,000
25-55
30-40%
Rourkela Steel Plant
Rourkela
Mining and Steel Manufacturing
18,000
19-65
26%
TATA Consultancy Services
Chennai
Technology and Business Services
50,000
25-55
30-40%
Bokaro Steel Plant
Bokaro
Mining and Steel Manufacturing
19,000
19-65
31%
Bhilai Steel Plant 
Bhilai
Mining and Steel Manufacturing
30,000
19-65
27%
TATA Steel
Jamshedpur
Mining and Steel Manufacturing
36,418
19-65
29%
Study Sample: Inclusion criteria are: aged ≥18 years; overweight or obese using World Health Organization 
defined South-Asian cut-points: BMI≥23 kg/m2 and/or waist 
circumference≥90 cm for men and ≥80 cm for women;75 have 
prediabetes (HbA1c of 5.7-6.4%) or diabetes (HbA1c≥6.5%); not 
currently taking any diabetes medications; not pregnant or 
breastfeeding; and without history of heart disease, current 
serious illness, or conditions which would impede participation in 
an unsupervised physical activity and diet change program.
Eligible individuals will be identified using a two-phased 
screening program at each worksite. All interested workers at the 
study site will be allowed to attend the Phase 1 screening visit and 
will be provided with a health report describing the results of the 
screening visit to share with their doctor. Phase 1 Screening will 
entail a short questionnaire with questions on demographics and 
general health behaviors and the Indian Diabetes Risk Score 
(IDRS) questionnaire, anthropometric measurements (height, 
weight, and waist circumference), and random capillary glucose 
(RCG) measurement. IDRS is simple to administer, includes only 
four questions (on age, waist circumference, physical activity, and 
family history of diabetes), is a reliable instrument for identifying individuals with diabetes and prediabetes, and 
can be easily used in the field and during program dissemination.76,77 Individuals with a RCG≥110 mg/dl or 
IDRS > 30 will be invited for Phase 2 Screening. Phase 2 Screening will include a fasting blood draw to 
measure HbA1c, glucose, and plasma lipids, blood pressure measurement, anthropometric measurements 
(height, weight, waist circumference), and a study questionnaire. The screening program will need to be low-
cost and easy to incorporate into a workplace setting, while still successfully identifying patients with 
prediabetes and diabetes. HbA1c testing is easy, can be done on a non-fasting individual, is relatively 
inexpensive, and is recommended as a diagnostic tool for diabetes and prediabetes by expert groups including 
the American Diabetes Association.41,78 Eligible and consented individuals will be enrolled in the lifestyle 

education program, and all individuals attending screening will receive a report of their results. Any individual 
presenting with results indicative of a health condition, including diabetes, will be referred to their primary care 
or company physician for clinical follow-up.
Preliminary data: D-CLIP [clinicaltrials.gov #NCT01283308, Emory University and Madras Diabetes 
Research Foundation (MDRF) investigators] is an on-going, translational, diabetes prevention study comparing 
standard lifestyle advice to a step-wise, culturally tailored program (group lifestyle classes plus metformin for 
participants not responding to lifestyle change alone) among 602 people with prediabetes in India.25 D-CLIP 
was developed based on the DPP Curriculum.79,80 Early unpublished D-CLIP results are promising. The 
participation rate for intervention classes was high (83%), and loss to follow-up was low (9%). At eighteen 
months, lifestyle participants had significantly greater reductions in weight (-1.7 vs. -0.8 kg), BMI (-0.6 vs. -0.3 
kg/m2), and waist circumference (-2.7 vs. -2.0 cm) than controls. Additionally, intervention participants showed 
greater improvements in systolic blood pressure, triglycerides, and HbA1c; 21% of controls achieved 
improvement in two or more of these risk factors while 33% of intervention group did so. Similar to previous 
studies showing that weight, BMI, and waist circumference reductions significantly predicted diabetes risk 
reduction in lifestyle interventions,81 preliminary D-CLIP analyses show a 51% relative risk reduction in 
diabetes incidence in intervention participants compared to controls.  The effects of the D-CLIP intervention 
were consistent across sex, age, income, education, and baseline BMI and glucose intolerance.82 
Recommendations for improving the Indian diet to better prevent diabetes and reduce cardiometabolic risk 
factors will be developed based on the work assessing the value of improving food quality of the Global 
Nutrition and Epidemiologic Transition (GNET) initiative at Harvard University and MDRF. For example, a small 
crossover trial of substituting brown rice for white rice for five days, found that brown rice lowered glucose 
levels by 19.8% and fasting insulin by 57%.40 GNET studies in other populations further support benefits of 
improving carbohydrate quality.38 Moreover, studies of acceptability of brown rice in India indicate that well-
informed, sensory trained panelists readily accepted brown rice,32 but translating this intervention to the public 
will require additional education and training.27 
The Intervention Package: The intervention 
package will include both an individual 
intervention (the lifestyle curriculum) and 
supportive changes to the worksite environment 
(see figure 2). The individual components will 
benefit those employees enrolled in the lifestyle 
education program, while any changes to the 
work environment would benefit all employees. 
The lifestyle education program will be based 
on the curriculum developed and tested in D-CLIP, 
modified to suit the workplace environment and 
based on feedback from focus group discussions 
(FGD) conducted at the end of D-CLIP lifestyle classes, experiences of the study team, and recommendations 
of key worksite contacts (e.g., worksite health workers and members of a study guidance committee made up 
of worksite managers, a worker representative from each site, and industry leaders). Core components of the 
intervention package include:
Eligible participants will be divided into classes of 10-12 people, and each class with be paired with one
trained lay educator and a professional health educator from the study staff (the health education team). Both
individuals will participate in training programs for delivery of health education with a focus on teaching 
healthy behaviors, leading by example, providing support, and facilitating group interactions. The 
professional health educator will provide continued on-site training and supervision for the peer health 
educator, team-teaching the first 2-3 lessons and then observing classes until the peer educator feels 
confident leading the classes alone. Various research studies have shown that using trained community 
health workers for patient management and peer education can be as effective as using health 
professionals18 and is a low-cost and sustainable method for improving patient outcomes, increasing 
knowledge, and preventing poor health outcomes (e.g., in a program of CVD screening and prevention in 
rural India83 and a lifestyle modification program for low income Hispanic Americans with T2DM6). Each site 
will employ one professional health educator and identify two-three lay educators from among the staff at the 
site. Lay educators will be employees of the worksites, and the worksites have agreed to allow these 
employees to perform their study-related duties as part of their workday. The training program will be 

developed collaboratively with the Diabetes Training and Technical Advisory Center (DTTAC, 
http://www.dttac.org, see Letter of Support) at Emory University, the group responsible for developing and 
delivering the train-the-trainer program for helping scale the national DPP in communities across the U.S. 
(http://www.cdc.gov/diabetes/prevention/training.htm).
The curriculum includes 24 sessions: sixteen core sessions weekly during the first four months of the 
program followed by eight monthly maintenance sessions. Each class will last one hour and will include: (a) 
20 minutes where the health educator will present a scripted lecture covering a health topic; (b) 20 minutes of 
group-based activities, for example role-playing exercises and group discussions; and (c) 10 minutes of 
physical activity training (see below). Topics to be covered include: importance of maintaining a healthy 
weight for diabetes prevention/maintaining healthy blood glucose levels, eating a healthy diet, increasing 
physical activity, overcoming barriers, and building social support. At the start of each session, participants 
will be weighed to chart their progress. All classes will be conducted at the worksite during the workday (e.g., 
over the lunch break, at the beginning of the day), depending on worksite and participant needs.
During the maintenance period (eight months beginning after the active period classes have ended), 
participants will attend a once monthly class covering topics such as maintaining healthy behaviors long-term, 
overcoming decreases in motivation, and educating others on healthy lifestyle behaviors. Maintenance 
classes will be supplemented with biweekly SMS text messages providing lifestyle advice, tips, and 
encouragement. The messages to be used were developed as part of a health promotion program designed 
by several partners on this project.84 During long-term follow-up (one year after beginning lifestyle classes 
through year five), the health education team will hold small group refresher sessions quarterly.
Participants will be given two study goals to achieve during lifestyle classes which are identical to those used 
in the DPP and D-CLIP studies:25,80 increase physical activity to at least 150 minutes per week of moderate 
level activity and lose at least 7% of their baseline body weight (via diet and activity changes). 
Since formal exercise is not a cultural norm in India, it is important to train participants on exercise safety and 
technique. These topics will be covered in the lessons, and at the end of each lecture, participants will learn 
one-two new stretching or strength training exercises. During the D-CLIP trial, participants attended weekly 
exercise classes, which were well received by study participants (unpublished qualitative data); however, a 
two-hour weekly class seemed difficult to implement and sustain in a work-based setting. Instead this training 
will be incorporated into the classes and participants will be trained on goal setting, planning, and 
overcoming barriers to help with implementing exercise daily. The lay health educators will also lead optional 
walking groups several times per week, open to participants and other employees.
Participants will be given the knowledge and tools necessary to improve their diet quality and quantity. They 
will be taught about portion sizes; monitoring hunger/fullness; increasing fresh fruit (not fruit juice) and 
vegetable intake, avoiding sugar sweetened beverages, choosing whole grains more often while reducing 
consumption of refined grains; choosing healthier fats for cooking; minimizing consumption of fried foods; 
choosing healthier protein sources; reducing sodium; and reducing total fat intake, when necessary, as a way 
to manage caloric intake. These guidelines follow decades of research on healthy diets by co-Investigators 
Willett, Spiegelman, and their colleagues.85-88 To facilitate these changes, the study team will work with the 
worksite canteens to create healthy options at all meals.
Individuals will be encouraged to keep food and activity dairies throughout the course of the study. Record 
keeping has been shown to be an important predictor of success in weight loss programs.89
Adaptive elements of the intervention (components that can be modified to suit individual worksites) are 
included so that worksites and health educators can tailor the program to the needs of participants and the 
work environment. These are:
Timing and composition of classes: Classes can be held anytime during work hours so that each worksite 
can choose class schedules that best suit the work environment and participants. The composition of classes 
(e.g., single sex, divided by type of job, etc.) will be determined at each site following discussions with 
management and employee representatives.
During each lesson, the health education team will be able to tailor the discussion and activities during the 
second half of the class to the study participants and worksites. For example, on a lesson on overcoming 
barriers, participants may want to discuss different issues specific to the worksite or types of participants.
Flexibility in what foods to offer at canteens: we will work with each study site’s management and canteen 
staff to help facilitate the incorporation of more healthy food items, tailoring the recommendations to account 
for regional differences in diet. 

The lifestyle program is designed to increase self-efficacy, teach individual goal setting and attainment, and
empower participants to make health decisions that they feel fit within their lives and are important to them.
Participants are given choices for how to reach study goals, and then can work towards these goals choosing
the tools that are right for them individually.
To minimize Type III error (poor or inadequate implementation of the intervention), an assessment of the 
fidelity to the intervention components will be conducted (see Data Collection and Data Analysis). Methods to 
maximize fidelity between study sites include: (1) The intervention has been previously field tested as part of a 
large randomized controlled translation trial (D-CLIP25) which included qualitative and quantitative 
assessments of the intervention delivery. The worksite intervention program will be created based on the 
results of the D-CLIP program assessment. (2) We will form a study guidance committee, chaired by the Chief 
Medical Officer of Tata Steel (Dr. Madhusudanan), which will include a member of senior management and an 
employee representative from each site as well as business organization leaders, to advise the study team on 
optimal conduct of the study. This group will be instrumental in making recommendations for program 
maintenance and dissemination after the trial. In addition, this group will have quarterly calls to update the 
study guidance committee on study progress and maintain involvement and investment in the intervention 
program by worksites. (3) Members of the health education team, including both staff and lay health educators, 
will participate in standardized training, including training on delivering the intervention, managing group 
interactions, and program content. To minimize intervention drift90 over the course of the program, all health 
education team members will participate in a monthly conference call, which will include booster training 
sessions and problem solving discussions. (4) Study manuals and protocols for screening, program delivery, 
and data collection, entry, and reporting will be provided to all study personnel and sites in the preferred 
language of the worksite. A multilingual team drawn from the study staff at PHFI, MDRF, and Emory will 
oversee translation of all materials, including back-translation to check and maintain consistency between 
versions of the documents. (5) The lecture part of each lifestyle class will be scripted and the group activity will 
have general guidelines to ensure that key messages are conveyed at each study class. (6) The coordinating 
center will conduct annual monitoring visits at each worksite. 
Data Collection 
This study will utilize mixed methods to assess program implementation (see table 2). 
Table 2: Data Collection and Analysis by Aim
Aim
Outcome being measured
Method
1
Adoption of the program (lifestyle class components and/or worksite environmental changes) by worksites 
and participants 
Qualitative
1
Adoption and adherence to the program (lifestyle class components) by participants by measuring changes 
in weight, diet and physical activity
Quantitative
1
Fidelity to program core components 
Qualitative
1
Fidelity to the program assessed through checklists for health education team and observations/records of 
changes made to canteen foods
Quantitative
1
Acceptability of the program (lifestyle class components and/or worksite environmental changes) to the 
workers, management teams, and participants 
Qualitative
2
Lifestyle education program effectiveness through changes in the primary outcome, a composite risk factor 
score including blood pressure, triglycerides, and HbA1c
Quantitative
2
Changes in secondary outcomes including rates of diabetes incidence and regression to normoglycemia, 
changes in the prevalence of 1-3 risk factor goals (improvements in triglycerides, blood pressure, and/or 
HbA1c) from baseline to end of study, and changes in anthropometry, lipids, and fasting glucose 
Quantitative
3
Impact of the intervention on worker satisfaction in their jobs and the company 
Qualitative
3 
Impact of the intervention on workers and the worksite specifically cost associated with the program, cost-
effectiveness, reports of absenteeism and productivity, health status and quality of life
Quantitative
Qualitative data collection (Table 3) will include a maximum of 32 FGD and 456 interviews (96 with 
supervisors, 200 with dropouts, and 160 with employees), providing rich qualitative data across and at each 
worksite. Qualitative data collection in each category and at each time point will continue until data saturation is 
reached (when no new information is being shared by participants).91 Participants in all categories will be 
recruited with the goal of identifying information-rich individuals who represent diverse groups at the worksite 
(different sexes, age groups, positions, etc.). Interviews will be used when understanding individual views are 
important (e.g., study dropouts may have individualized reasons for stopping the program) or when collecting 
data that individuals may be unwilling to share in a group (e.g., feedback on employee satisfaction, reports of 
worksites not implementing program components). FGD will gather community (in this case participant) level 
views on the intervention. All interviews and FGD will be conducted by a trained interviewer/moderator who is 
of the same gender as the participants to retain group homogeneity, thereby promoting a more open 

discussion.92 The discussions will be guided using semi-structured interview/FGD guides, which will be 
informed by the D-CLIP study and made culturally appropriate for the target individuals and setting. Guides will 
be pilot tested, refined, and translated before use in the field. FGD and interviews will be conducted in the 
preferred language of participants and will be audio-recorded with a digital recorder, transcribed verbatim, and 
translated into English. To enable comparisons between subsets of those interviewed (e.g., different age 
groups, etc.), participants in the qualitative research will fill out a brief demographic survey. 
Table 3: Qualitative Data Collection Tools
Method 
Participants
Maximum Number 
and Timing
Recruitment 
Method
Topics
In-depth 
Interviews
Managers/ 
supervisors 
4 per worksite: 2 
high-level managers 
(make decisions 
about the worksite 
environment) and 2 
supervisors (provide 
direct supervision to 
employees) in years 
1, 3, and 5
Worksite will be 
asked to provide a list 
of managers and 
supervisors. The 
study team will 
contact people from 
the list until interested 
participants are 
identified.
Perceptions of diabetes and overweight/obesity 
(year 1, 3, 5)
Worksite’s role in health promotion (years 1, 5)
Perceptions of the program (years 3, 5)
Changes made at worksite due to the program and 
feelings around these changes (years 3, 5)
Suggestions for improvements and future 
programs and for independent implementation and 
sustaining of program at worksites (year 5)
In-depth 
Interviews
Program drop-
outs
25 per worksite 
conducted throughout 
the intervention 
period
Individuals who drop 
out of the program 
will be contacted for 
interviews.
Perceptions of obesity/overweight, weight loss, 
diet change, and exercise
Reasons for drop-out
Likes/dislikes about the program
Suggestions for improvements
Focus 
group 
discussions
Program 
participants
2 groups of men and 
2 groups of women at 
each worksite at the 
completion of the 
intervention
Health education 
team will identify 
information rich study 
participants.
Perceptions of obesity/overweight, weight loss, 
diet change, and exercise
Likes/dislikes about the program
Suggestions for improvements
In-depth 
Interviews
Employees at 
worksite
10 program 
participants/10 non-
eligible employees 
per worksite in years 
3 and 5 
Flyers will be placed 
around the worksite 
(break rooms, 
announcement 
boards, etc.) asking 
individuals interested 
in participating to 
contact study staff.
Awareness and views of program 
Perceived support for program by management
Questions to assess fidelity to intervention by 
worksites and health educators 
Changes made/sustained at the worksite during 
the program
Suggestions for how worksite could promote 
healthy lifestyles
Quantitative data collection (Table 4) will occur at study-testing visits at baseline and every twelve months 
after lifestyle classes begin. Whenever possible, validated study instruments will be used. The primary 
outcome assessing program effectiveness (Aim 2) will be a composite of achieving two or more 
cardiometabolic risk goals; participants will be scored on the number of risk factors they improve on (0-3) with 
success delineated by a HbA1c decrease ≥0.5%; a systolic blood pressure decrease ≥5 mm Hg; and a 
decrease in plasma triglycerides ≥10 mg/dl. This outcome was selected for three reasons: other risk scores for 
CVD (e.g., the Framingham Risk Score) do not perform as well in South Asian populations;93 these risk factors 
are commonly measured by clinicians, so the results are clinically appropriate; and the composite outcome 
allows for individual variation in risk factor profiles and the ability of individuals to reduce different factors (e.g., 
an individual with a baseline HbA1c of 5.8% is unlikely to reduce this risk factor by 0.5%, but may succeed in 
reducing triglycerides or blood pressure). 
Table 4: Quantitative Data Collection Tools
Timing 
Variable of interest (test)
Outcome of test
S
B
A
FU
Demographics and Lifestyle Behaviors
Demographics (SQ)
Describe study population
X
X
History of smoking (SQ)
Smoking status and cessation rates 
X
X
X
Global Physical Activity Questionnaire (GPAQ)94 
Baseline and changes in physical activity 
X
X
X
Dietary intake (food frequency questionnaire)
Study specific food frequency questionnaire on dietary intake 
of foods targeted in the intervention
X
X
X
Dietary behaviors (SQ)
Prevalence of diet-related behaviors (e.g., reading nutrition 
X
X
X

Timing 
Variable of interest (test)
Outcome of test
S
B
A
FU
labels, eating at restaurants, measuring portions, etc.)
Weight loss history (SQ)
Weight loss history including number and success of past 
attempts, methods used, etc.
X
Quality of life (EQ-5D)
Baseline and changes in quality of life
X
X
X
Self-reported health (SF-12 and SQ)
Health status, recent health events and medication use (type 
and dosage of all prescription and over the counter 
medications and herbal remedies)
X
X
X
Worker satisfaction (SQ)
Questions assessing worker satisfaction with worksite, number 
of days missed work, self-described levels of productivity
X
X
X
Health-related outcomes
Glycemic control (HbA1c)
Identify eligible participants and assess improvement
X
X
X
X
Glycemic status (venous fasting plasma glucose)
Assess effects of program on glycemic status
X
X
X
Height and weight (stadiometer; weighing scale)
Baseline and changes in weight (kg), BMI (kg/m2) and 
percent overweight/obese
X
X
X
X
Waist circumference (non-elastic tape measure)
Baseline and change in waist circumference 
X
X
X
X
Blood pressure (automated blood pressure 
machine)
Baseline and change in blood pressure and hypertension
X
X
X
X
Lipid profile (fasting venous triglycerides, HDL, LDL)
Baseline and change in plasma triglycerides, LDL-
cholesterol, and HDL-cholesterol
X
X
X
X
Measures of Program Cost
Cost questionnaire (SQ)
Participant cost of diabetes care and medicines for diabetes, 
blood pressure, and lipids, prevention, and complications
X
X
X
Program costs (data collection from worksite, 
study records)
Cost (monetary, person time, etc.) of delivering program
X
X
Worksite productivity (worksite records)
Absenteeism, presenteeism, productivity, turn-over
X
X
X
Program Fidelity and Acceptability
Weekly checklists for health educators
Checklists of required and optional activities for health 
educators to fill out weekly
X
X
Participation in lifestyle intervention (attendance 
records, number of diet/activity records turned in)
Program attendance and adherence
X
X
Participant feed back (SQ)
Acceptability of program components and suggestions for 
improvement
X
X
S = Screening; B = Baseline; A = Annually throughout follow-up period; FU = End of follow-up; SQ = study questionnaire; HbA1c = 
glycosylated hemoglobin; BMI = body mass index; LDL = low-density lipoprotein; HDL = high-density lipoprotein
Data Analysis
When appropriate, all data analysis will be conducted for the entire study and individually by site. Qualitative 
data will be comprised of the translated, verbatim transcripts of the in-depth interviews and FGD. Textual data 
will be managed using the MAXqda10 (VERBI Software, 1989-2012). A codebook for each set of qualitative 
data will be created, tested for inter-coder reliability, and used to code the transcripts. When appropriate, 
qualitative data will be used to modify and improve intervention components and guide selection of adaptable 
components at each site. De-identified quantitative data will be entered into Microsoft Access databases. 
Range checks, disallowing invalid values, and adaptive double entry, along with regular data audits will ensure 
the accuracy of the electronic data. Data analysis will be conducted using SAS primarily. Descriptive analysis 
will be performed for all variables and outliers will be investigated for data errors. A probability of <0.05 will be 
considered statistically significant for all tests. 
Aim 1: Success of program implementation will be assessed as follows:
a)Program Adoption: Program adoption will be measured by quantifying participation in the program and 
success in reaching the goals of the lifestyle education program (weight loss, increased physical activity and 
diet improvements). Participation will be measured by calculating the percentages of total employees 
agreeing to screening, agreeing to participate in the program, and enrolling in lifestyle classes. Attendance 
records for study classes and other activities and numbers of diet/activity tracking booklets turned in for 
review by the health educator will be reviewed to determine percent attendance at each class and at classes 
overall. Physical activity [in Metabolic Equivalent of Task (METS)/day] will be quantified using the Global 
Physical Activity Questionnaire (GPAQ).94 Diet changes will be quantified through a study-specific food 
frequency questionnaire, which will include food items that participants are encouraged to eat more or less 
often, as well as questions on diet-related behaviors (e.g., reading food labels, measuring portion sizes). A 
healthy diet score will be calculated from the food frequency questionnaire and other diet related 
questions.95,96 Changes in weight, BMI, waist circumference, physical activity, and diet score over time will 

be modeled using generalized estimating equations for clustered, repeated measures data,97 and 
heterogeneity in the intervention effect over time on each outcome by education, income, gender, age, 
baseline BMI category (normal weight, overweight, and obese), baseline physical activity, and baseline diet 
score will be evaluated.
b)Program Fidelity: Program fidelity will be determined by measuring study-affiliated activities by the health 
education team, study canteen, and worksite management, changes in the worksite environment, and 
management support for the program. Checklists will be created for each study class and between-class 
activities (e.g., reviewing food and activity records, interactions with participants) to gather self-reported 
fidelity by health educators. Reasons for non-compliance will be assessed during monthly calls with the 
health education teams. To assess compliance to recommendations to provide healthy food options in the 
canteen, twice per year a member of the study team not affiliated with the worksite will do a random audit of 
available canteen foods and daily canteen menus will be collected and analyzed to determine amounts of 
and changes in number and types of healthy foods offered. In-depth interviews with employees (both 
program participants and non-participants) and managers/supervisors will be conducted to assess changes 
made at the worksite during the program. 
c)Program acceptability: We will assess program acceptability through in-depth, semi-structured interviews 
with managers and supervisors at the study sites, lifestyle program dropouts, and employees at the worksite 
(both program participants and ineligible/uninterested employees) and through FGD with program 
participants. Qualitative data will be supplemented by multiple choice and yes/no questions included on 
participant questionnaires asking about specific components of the lifestyle intervention (e.g., “How often do 
you choose brown rice instead of white rice?” or “Do you keep diet records?”). Percent reporting various 
answers and comparisons of percentages will be calculated.  
Dr. Hennink, an expert on qualitative methods, particularly in low- and middle-income country settings,98,99 
will provide expertise and guidance for the collection and analysis of all qualitative data. Drs. Weber, Willett, 
and Spiegelman also have experience with qualitative data.27,34,39,100 For qualitative data collected for parts b 
and c above, we will conduct a thematic analysis 91 to describe program acceptability and fidelity at different 
levels (program participants, worksite, and worksite management) and summarize suggestions for improving, 
sustaining, and disseminating the program. This analysis will include: (a) a descriptive analysis to identify core 
themes across sub-groups  (e.g., managers, dropouts, women only, younger participants, etc.) and (b) a 
comparative analysis between groups to distinguish the context of each issue and different perceptions of 
barriers, facilitators, sustainability, etc. In addition, if the data is sufficiently rich, we will conduct a grounded 
theory analysis101 to explore experiences and qualities of worksites which predict better fidelity to the program.
Aim 2: Statistical analysis of intervention impact: A generalizing estimating equations (GEE) framework for 
clustered data97 will be used to assess the statistical significance of any observed intervention effect on the 
endpoints. For the primary endpoint, the dependent variable will be the indicator for whether the study participant 
is at two or more cardiometabolic risk factor reduction goals at the end of the 3 year follow-up period, minus the 
expected probability of this endpoint in the absence of an intervention, to be taken as 21% as observed in the D-
CLIP25 control group. An exchangeable working correlation matrix will be used to incorporate the clustering within 
the 8 work-sites, with a log link and binomial variance specified. The exponentiated point and interval estimates 
from the intercept of this model will quantify the intervention effect, and the p-value associated with the model’s 
intercept will provide a measure of the statistical significance of the findings. A similar GEE approach will be used 
to estimate and test the significance of intervention effects on secondary endpoints. For continuous markers, 
such as systolic blood pressure and HbA1c, the post- to pre- within-participant difference will serve as the 
dependent variable in a GEE model as above, with the identity link function and the distribution specified as 
normal. The change scores will be evaluated for outliers, and analysis will be repeated with and without extreme 
outliers.  For the cumulative incidence of diabetes at end of follow-up, participants will be coded as one if they 
satisfy the diabetes definition at end of follow-up and 0 otherwise. A Cox proportional hazards regression model 
for the diabetes incidence rate will also be considered, and if dropout or loss to follow-up are non-negligible, 
causal methods for adjusting for dependent censoring will be applied.102 A similar approach will be used to 
assess regression to normoglycemia. We will consider worksite-level covariates in multi-level models to examine 
how these aspects might affect findings. Additional secondary endpoints will be considered (e.g., changes in 
being at 1, 2 and 3 CVD/T2DM risk factor goals). Although the study is not powered to detect it unless quite large 
and although no effect modification is expected, we will assess the presence of effect modification by calculating 
intervention effect estimates stratified by potential modifiers, such as gender, age, marital status, socio-economic 
status, and assess the statistical significance of any effect modification observed by calculating a cross-product 
term between the potential modifier and the intervention, using a robust score test to assess the significance of 

this term.97 To assess the causal effect of the intervention adjusted for bias due to non-adherence and loss to 
follow-up, marginal structural models will be fit, embedded around the analysis approaches outlined above.103 
The study statistician, Dr. Spiegelman, has substantial experience fitting these causal models to adjust for time-
dependent confounding and dependent censoring, e.g.104-107. 
Aim 3: Impact of the intervention on workers and worksite: Qualitative data from interviews with employees 
on job satisfaction and views of the company and worksite will be described using the thematic analysis 
methods described in Aim 1. The analyses below are aimed at helping stakeholders that might consider 
adopting this intervention program to be fully informed of the upfront (fixed) and recurring (variable) costs to 
deliver the intervention and the potential return on investment (ROI). We will use an employer/societal 
perspective and will report cumulative and per-site estimates. Analyses for this aim will include:
a)Estimating total costs to deliver the intervention: we will estimate average fixed and variable costs of 
delivering the lifestyle change program at worksites in India. Specifically, we will collect cost data from each 
worksite regarding components of the intervention: 1. Screening for high-risk individuals; 2. Delivering the 
individual lifestyle education program (per employee enrolled), which include labor costs for lifestyle 
coaches and classes and education materials; and 3. Changing the work environment (per campus and per 
1,000 employees), which include costs for subsidizing purchase and preparation of healthy foods, as well as 
any capital costs (e.g., gym facilities, walking paths).
b)Staff productivity (absenteeism; presenteeism) and indirect costs: Absenteeism will be calculated from 
worksite attendance records. To assess presenteeism, we will administer a questionnaire that captures 
performance of employees (specific markers of productivity for each worksite and employee function). We 
will calculate indirect costs (monetary value of lost productivity) using the human capital approach 
(multiplying combined days lost to absenteeism plus presenteeism by salary of different occupational roles). 
Changes in these measures over the course of the program will be modeled for each study site and for all 
study sites using mixed methods models. 
c)Health status and healthcare utilization of employees: The self-reported health status of the employees 
participating in the lifestyle intervention will be determined using the SF-12 questionnaire and study 
questions on health status, hospitalizations, and medication use. Changes in health status and utilization will 
be modeled over time and compared across worksites, levels of program adherence, and baseline health 
status (e.g., comparing those with diabetes and prediabetes). 
ROI (cost-benefit and cost-utility analyses): To estimate potential ROI for worksite leaders, we will calculate an 
overall cost-benefit in monetary terms. To do this, we will identify the costs incurred by employers in the years 
prior to the study and costs during the study (incremental investments). We will then identify total benefits 
(cumulative indirect costs) prior to the study and during the study (annually, and at completion). We will consider: 
1. Cost-benefit (ratio of incremental costs to change in productivity) without any health expenditures (assumes 
employer doesn’t pay for employees’ health care); 2. Cost-benefit that includes aggregated medical (physician 
consultations, medications, diagnostic tests, inpatient stays) and lost productivity costs, which assumes 
employers pay for employee healthcare; and 3. Cost-utility ratio (net costs to net utility: costs of intervention – 
average costs in previous years / utility of intervention – utility of control). To calculate utility, we will use the 12-
monthly health utility measure, the quality adjusted life year (QALY), which is calculated as the sum of mean 
survival time [life years] x utility scores at 12, 24, and 36 months. We will report 12-, 24-, and 36-month costs per 
QALY.108 If the intervention is successful, we will also compare modeled long-term cost-utility of the intervention 
and usual care using Markov Chain Monte Carlo estimation techniques, controlling for age, gender, and risk 
factor prevalence under different plausible scenarios for how these may evolve over time.109 We will compare 
this to reference points from the literature – e.g., ceiling ratios for costs per QALY that are less than three times 
GDP per capita110-112 are considered cost-effective (India’s 2013 GDP per capita was $3,990; threshold: 
≤$11,100 per QALY).113 We will use sensitivity analyses to examine the effects of varying discount rates, costs of 
the intervention, and effectiveness. Drs. Ali and Narayan have expertise in economic analysis114-123 and will 
consult with Dr. Ping Zhang, health economist at CDC, as needed. 
Sample Size Selection: This worksite-clustered before-after design of 8 worksites with at least 250 eligible 
and enrolled participants per site and no more than 20% loss to follow-up (LTF) after 3 years will have 93% or 
more power to detect an estimated difference between the percent of participants at 2 or more CHD risk factor 
goals after 3 years of follow-up, the primary effectiveness endpoint of this trial, of 33% or greater, compared to 
the comparable D-CLIP25 percentage of 21%. The 20% 3-year LTF rate is likely conservative, as only 9% of D-
CLIP participants have been lost to follow-up after a mean of 30 months. Similarly, the D-CLIP comparative 
percentage of 21% is likely conservative, because the D-CLIP control group also experienced a minimal 
intervention that included meeting with a physician and a dietician, attending two classes (a lecture on diabetes 

prevention through weight loss and diet change, and an exercise class), and receiving handouts reinforcing 
prevention of T2DM. Thus, compared to a community control receiving none of these services, the D-CLIP 
group would be expected to have a higher percentage at or exceeding two goals, compared to the community 
standard. In addition, power in this study is excellent for numerous secondary effectiveness endpoints of 
considerable interest, including 90% power or more to detect a decrease of 2mmHg or greater in systolic blood 
pressure ( =0.10, IIS), 95% power or more to detect a decrease in HbA1c of 0.14% or greater  ( =0.10, IIS), 
ρ
ρ
and nearly 100% power to detect a reduction in diabetes incidence of 30% or greater among the 2/3 of the 
study participants with prediabetes at baseline screening, compared to the baseline rate of 0.07/year,124 
otherwise under the same assumptions as the primary endpoint calculation.
All qualitative data collection will continue until data saturation is reached. The maximum number of 
groups/interviews to be conducted was selected based on prior experiences of the research team, in particular 
the number of interviews/FGD required to reach saturation in the D-CLIP trial. The maximum number of 
program dropouts to be interviewed (25 per site) was selected because this corresponds to half of the number 
expected to withdrawal from the program if maximum loss to follow-up of 20% occurs. The number of FGD (4 
per worksite) will include, assuming ideal group sizes of 8-12 people, 32-48 people, approximately 12-20% of 
the lifestyle intervention participants, which should be a sufficient cross-section for describing the experiences 
and opinions of the participants. The numbers of other interviews (at two time points: 4 managers/supervisors, 
10 participants, and 10 non-participants at each worksite) were selected based on estimates of numbers 
needed to reach saturation while maintaining a manageable number of interviews for study staff.
Timeline
The study timeline is shown in Table 4. The study will last five years, with one year for planning and 
training of staff. Before contact with any participants, the final study protocol, consent documents, and 
data collection tools will be submitted for approval to the Emory University Institutional Review Board, 
the PHFI Ethics Committee, and the MDRF Ethics Committee. Screening and enrollment of intervention 
participants will occur on a rolling basis with two worksites starting screening every month beginning in month 
13 of the study. Screening at each site will last for four months. During the final month of screening at each 
worksite, the first lifestyle classes will begin and new classes will be added as sufficiently sized groups of 
eligible employees are identified. Mean follow-up time (time from end of core lifestyle classes to end of study) 
will be 36 months. Data collection and analysis will be conducted throughout the trial and changes will be made 
if needed to improve and sustain the programs. Publication and presentation of results will occur in year two 
(for baseline results and study design paper), midway through the intervention (early results, results of post-
intervention interviews/focus group discussions), and at the end of the study (final results). Dissemination plans 
are described below in Dissemination.
Table 5: Study Timeline
Month of Study
Activity
1-6
7-12
13-18
19-24
25-30
31-36
37-42
43-48
49-54
55-60
Project planning*
Convocation and meeting of steering committee 
Training of staff/lay interventionists, data collection teams
Screening
Intervention classes (core sessions)**
Intervention classes (maintenance sessions)**
Follow-up period#
Data collection and on-going analysis
Publication/presentation of results
*Project planning includes: finalizing intervention lesson plans and training materials for health educators, data collection tools (e.g., 
study questionnaires, interview/focus group discussion guides), and protocols; identifying and hiring/securing study staff and peer 
educators; and obtaining IRB approval for all study activities
** Start times for study sites and class cohorts (2 groups of 5 lifestyle classes each) are staggered slightly to minimize burden on study 
staff and study sites. Each class participates in core lifestyle classes for four months followed by eight monthly maintenance sessions.
# Follow-up period will include monthly maintenance classes and text messages send every other week with encouraging messages 
and tips on maintenance of healthy habits for eight months post-core lifestyle classes, twice per year small group meetings with health 
coaches (after the end of maintenance classes), annual testing, and continued availability of health coaches.
Study Team and Governance 
This experienced and multi-disciplinary research team from two U.S. and two Indian institutions has already 
collaborated extensively on research in the areas of diabetes prevention, epidemiology, nutrition, and diabetes 
treatment (for example25,32,33,40,44,69,125-127). Dr. K.M. Venkat Narayan, a leader in diabetes and translational 
research, will act as study P.I. and chair of the study steering committee. Dr. Prabhakaran, director of CARRS 
at the Public Health Foundation of India (PHFI) in New Delhi will serve as the Indian P.I. and director of the 

coordinating center, which will be held at PHFI.  An intervention coordinating team, led by Dr. Ranjani will be 
based at the MDRF. The steering committee will include the study PIs, Emory investigators (Weber, Ali, 
Hennink), Harvard Investigators (Spiegelman, Willett), Indian researchers (Mohan, Ranjani, Jeemon) and 
representatives from the leadership at each worksite. The steering committee will meet at baseline, midpoint, 
and at the end of the trial, with subcommittees (e.g., intervention, data analysis subcommittees) forming and 
meeting by phone/virtually more often as needed. The Emory team brings expertise in diabetes translation, 
lifestyle change, qualitative research and economic evaluation; the Harvard team provides expertise in nutrition 
and statistical analysis; PHFI bring expertise in multisite study coordination; and MDRF provide expertise on 
diabetes prevention and lifestyle intervention in the Indian context. 
Sustainability, Dissemination, and Future Plans
A major focus of this project is to demonstrate full-scale sustainability at worksites across India, with further 
interest in translation beyond the Indian context. As part of the program, staff members at the sites will be 
trained in delivery of lifestyle education, providing healthy food options to employees, and motivating healthy 
decisions at the workplace. These efforts can be easily sustained by the worksites long after the trial ends and 
will be particularly appealing to management if shown to be cost-effective and able to increase productivity. 
The involvement of industry leaders and worksite managers and employees (the study guidance committee) in 
program planning and frequent interactions with health education teams, study participants, and management 
(allowing for rapid adjustments to the study protocol if needed) will ensure a program that is acceptable to the 
worksites and targeted to the needs of workers. The results of the trial will be used to tailor the program so that 
it can be disseminated in a way that is acceptable, feasible, and effective at other worksites.
The study guidance committee will contain industry experts who can help advise on how and where to 
disseminate the lifestyle program to create a healthier workforce. Initially dissemination efforts can focus on 
implementing the program at other worksites and units within the companies involved in this study (including 
those in the U.S.). If additional funds can be identified, we will also set up a program housed at PHFI or 
another Indian partner to provide advice and tools to companies and worksites wanting to implement lifestyle 
education programs for their employees. Results of the study, with links to available materials and manuals, 
will be published in scientific journals and on the PHFI and other websites related to study investigators. Press 
conferences will be organized to announce the program and study results to the media. We will also utilize 
available networks already formed between the business community and study investigators at PHFI and 
MDRF (e.g., Dr. Prahbakaran serves on the Expert Committee on Health at the PHD Chamber of Commerce 
and Industry) and with other contacts working to promote worksite fitness or chronic disease prevention (e.g., 
Arogya World http://www.arogyaworld.org). When appropriate, results of the study will be used to make 
recommendations or plan similar studies or programs in other countries including the U.S.
A number of additional analyses that have broad policy implications will be made possible upon study 
closeout. This includes analyses which strive to disentangle the separate effects of the intervention package 
components by using causal inference methods128 to exploit non-adherence to elements of the intervention by 
individual participants and using external data (e.g., the ongoing longitudinal observational CARRS study129 
led by the PIs of this proposal and underway in some of the same cities in which this intervention will be 
conducted) as a comparator to the intervention effects, making it possible to adjust for confounding by 
contemporaneous secular trends, imparting this analysis with the flavor of a parallel group longitudinal design 
with an explicitly randomized control group. In addition, complementary empirical social network 
construction130 and agent-based modeling approaches131,132 could quantify the extent to which the intervention, 
or parts thereof, spreads to workers at the same worksite who were ineligible for the intervention and to family 
members and friends. Further predictive modeling of impact and cost effectiveness into the future can be 
conducted to investigate the extent to which the intervention can contribute to stopping or mitigating the 
growing Indian diabetes and CVD epidemics. With inputs appropriate in the U.S. or other country contexts, 
modeling can be conducted that would be relevant domestically and in other countries undergoing the 
nutrition/epidemiologic transition.133,134 Finally, utilizing the data from this intervention as well as additional 
information, decision-makers in industry, health care delivery and government can be brought together for a 
systems dynamics exercise which can be used to map out the full set of societal benefits and risks of this 
intervention, and further estimate its effectiveness and cost-effectiveness.135 We will seek separate funding for 
these complementary activities and attempt to secure them while the intervention is ongoing, in order to obtain 
the necessary auxiliary data contemporaneously. 
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