A Randomized Controlled Trial Enhancing NonCommunicable Diseases Health Literacy of Indian Youth

There is a theory-praxis gap related to health literacy interventions focused on non-communicable diseases (NCD) among young people. We designed a NCD curriculum and investigated its’ effect on health literacy in non-medical, non-nursing college students in India. We deliberately selected non-medical and non-nursing college students as we hypothesized they would have minimal baseline knowledge of NCDs. Methods We initially carried out a pilot study in 85 students in a four-day long workshop (12 teaching hours) using empirically developed health literacy instrument. We administered the curriculum to 120 randomly selected students in 4 colleges, while 50 students were controls. The curriculum was given over 4 days for a total of 32 hours. Each lecture comprised of didactic lecture followed by discussion and skills testing of measuring BP and blood sugar. Health literacy was measured using a specically designed tool at baseline and endline. Difference in health literacy scores between the two time-points was analyzed using the t-test. Multiple linear and Poisson regression models were used for covariates.


Introduction
Non-communicable diseases (NCD) are a critical global concern due to the signi cant mortality and morbidity 1 . The signi cant socio-economic impact associated with NCD threatens sustainable development, necessitating action at global, regional, and national levels 2 . An epidemiological transition with escalating burden of NCDs are evident across India. This is complicated by disease onset a decade earlier in Indians compared to residents of high-income countries, increasing their risk of adverse medical and socio-economic consequences 3 .
NCD risk factors may be higher among youth since it is a transformative time, characterized by experimentation and susceptibility to risk behaviors 4 . It has been shown that the youth in India have low levels of awareness about NCDs 5 , as well as the requisite skills to make healthy lifestyle choices 6 . There is a high prevalence of NCD-related risk behaviors and metabolic risk factors in this age group. It has also been shown that this age group is exposed to a barrage of media messages that in uences their health behavior, which makes it imperative to empower youth to make informed lifestyle choices 6 .
Health literacy skills empower young people to make informed health decisions throughout their life 7 . Moreover, health literacy in youth has the potential to extend well beyond them, young people can spread health-related messages to their families, peers, and others in their social network, thus acting as agents of social change. Health education and health literacy are widely recommended as cost-effective measures to reduce preventable NCD risk factors, speci cally, actionable recommendations based on context-speci c health literacy interventions are emphasized in order to prevent and control NCDs.
A way to develop health literacy skills in young people is to incorporate them in formal education 8 .
School-and college-based interventions have been proven to be cost-effective 9 . Lifestyle interventions with school and college going youth in India have shown the potential to increase awareness about NCD and related risk factors. However, only a few of these studies have used a randomized controlled design to evaluate their effectiveness. Most of these interventions have primarily targeted health behavior change, with health education as the primary component. Improved health literacy is conceptualized as a primary outcome of health education within the broader context of health promotion.
Research on health education with a health literacy focus is at an early stage in India. Although we found several studies assessing extent of health literacy and its association with health status, especially in areas of dental and mental health, child undernutrition, and NCD self-management 10 , we could not nd any intervention study that operationalized health literacy in the Indian context. Current efforts towards addressing health awareness in NCD in India 11 , include online resources, and school curricula. These are however, limited by one or more of the following -minimal emphasis on practical application, and lack of emphasis on critical thinking.
Our literature search con rmed that nutrition education curricula taught in secondary schools in India have been critiqued by teachers, parents and participants as being outdated, inadequate in imparting practical skills, and emphasizes rote learning 12 . This highlights the theory-praxis gap related to health literacy interventions across age groups, especially in NCD-related literacy interventions. We, therefore, investigated the effect of a contextually-relevant, theory-informed, health literacy curriculum on NCD literacy among non-medical and non-nursing college students in the State of Gujarat, India. We deliberately selected non-medical and non-nursing college students as we hypothesized they would have minimal knowledge of NCDs.

Methods
We have used the CONSORT guidelines to report our trial 13 .
Speci c objectives: To design, deliver, and test the effectiveness of a health literacy curriculum in increasing NCD-related health literacy as measured by a speci cally designed questionnaire in college students in Gujarat, India. We planned a randomized controlled trial with intervention and control groups to evaluate the effectiveness of the curriculum.
Theoretical premise: The theoretical premise of the curriculum was health literacy within the health promotion paradigm, viewed through a social epidemiological lens. Following the World Health Organization preamble, we conceptualized health literacy as "the personal, cognitive, and social skills which determine the ability of individuals to gain access to, understand, and use information to promote and maintain good health." We considered health literacy as a key determinant of health and health equity 14 . We adopted the Health Literacy Skills ( We have modi ed the HLS framework in the following domains: 1. The framework posits that ecological in uences moderate components of conceptual framework in several ways. We extended this proposition to an upstream level, emphasizing the in uence of broader social, political, and economic in uences, from global to contextual level in producing and maintaining systematic health differences within and across populations through a range of mechanisms and pathways.
2. We contend that engaging in a health behavior does not necessarily lead to improved health outcomes for two reasons. First, health behavior needs to be sustained before health impact becomes visible at the community level; however, the determinants of sustenance of behavior appear to be different from the determinants of initiation of behavior change and may remain unaddressed. Second, a range of health determinants other than behavior change such as the health system, environment, food policies and other upstream determinants can affect health outcomes, which may remain unaltered.
3. We incorporate critical health literacy as a dimension of health literacy skills. As Nutbeam posits, adequately emphasizing critical health literacy has the potential to act laterally to promote social action that impacts social determinants of health.
4. We extend the concept of a dynamic nature of health literacy in the HLS framework and propose that health literacy skills further amplify this through a feedback loop from comprehension of stimuli to knowledge (Figure 1).
Content selection: Curriculum content was informed by the theoretical framework ( Figure 1). We primarily focused upon two health conditions i.e. high blood pressure and diabetes mellitus, both have a high prevalence in India 17 ; and preventable risk factors, dietary modi cations and physical activity.
Development of the curriculum: We consulted several sources such as textbooks and peer-reviewed literature in clinical medicine, human physiology, health promotion, disease prevention, behavioral risk factors, food and nutrition science, exercise physiology, health behavior change theories, and health education. We reviewed regional variations in food practices across India, as well as social causes of health disparities 18 . We referred to food labelling laws, including their historical context in Indian and global contexts 19 .
Content validity: The content was developed and peer-reviewed by a team of experts, which included social epidemiologists and public health practitioners with a background in medicine, health education, nutrition, and health promotion.
Developing the evaluation tool: A number of approaches and instruments have emerged for measuring health literacy 20 . However, none were sensitive and speci c to objectively assess impact of our intervention. We therefore, developed an entirely new health literacy instrument to assess functional, communicative, and critical dimensions of health literacy. The nal measure comprised 22 questions and participants were given 50 minutes to complete the test (Table 2).
Pilot test: We carried out a pilot study in 85 students in a four-day long workshop (total of 12 teaching hours) and carried out baseline and endline data collection using the empirically developed health literacy instrument.
Sample size estimation: We de ned our outcome of interest as average difference in percentage scores between endline and baseline in the intervention and control groups. We used formula to determine the sample size as suggested by Smith et al. 21 .
For 90% power, signi cance level of 95% and estimated value of SD of outcome variable in both the groups at 15, the estimated sample size to detect a difference of 10% between both the groups was calculated to be 47 in each group.
Sampling design: We administered the curriculum to 120 randomly selected students in 4 non-medical and non-nursing colleges in the city of Ahmedabad, while 50 students served as controls.
Implementation of the intervention: The modular design of the curriculum given over 4 days for a total of 32 hours. (Table 3) from January 2018 to April 2018. Each lecture comprised of didactic section followed by discussion and skills testing of measuring BP and blood sugar. The rst author was accompanied by a research fellow who helped with logistical arrangements and recording observations and feedback.
Data collection: Baseline and endline data in the intervention group were collected after delivering the modules. In the control group, we also collected baseline and endline data but no teaching was given.
Data analysis: Statistical analysis was carried out using STATA data analysis software, version 12.1, owned by StataCorp, Texas, USA, and licensed to the host institute. We calculated the baseline and endline scores using the answer key we had developed along with the evaluation tool. The total score obtained was converted into a percentage using the maximum possible score as the denominator. Baseline and endline scores in percentage were treated as continuous variables.
We calculated the difference in percentage points between endline and baseline scores by subtracting the baseline percentage from the endline percentage for all study participants. We carried out a t-test for comparing mean difference-in-difference scores between the two groups. Multiple linear regression models were tted accounting for the background characteristics, study site and baseline percentage as covariates.

Results
Intervention and control groups were comparable at baseline as shown in Table 1. Mean age of participants in the intervention group was 19.2 years (SD 1.8 years) and 19.6 years (SD 1.4 years) in the control group.
Study groups were comparable in terms of percentage scores on health literacy at baseline. The intervention group showed an average of 20.6% points higher health literacy score at endline versus control group (p<0.001). The endline-baseline difference in health literacy scores were signi cantly different (p<0.001) between the two groups. The mean endline difference scores were comparable across background characteristics in both groups, with one exception: those with and without the intention to improve tness in the intervention group (p<0.05) (data not shown). None of the background characteristics showed statistically signi cant associations with the difference-in-difference scores independent of intervention (data not shown).
Based on the multiple linear regression models, the average difference-in-difference scores (endlinebaseline) was 18.49 percentage points higher in the intervention group as compared to the control group, accounting for college setting and percentage score at baseline (p<0.001). The proportion of participants scoring 40% or above on the health literacy measure in both groups were comparable at baseline. However, the proportion of participants scoring 40% or above was higher in the intervention group versus control group at endline (p<0.001).
Based on Poisson models, the incidence risk ratio of participants scoring 40% or above on the health literacy measure at endline was 2.37 times (p<0.05) higher in the intervention group versus control group, after adjusting for baseline health literacy score in percentage points and study sites.

Discussion
Our ndings suggested that our theory-based, context speci c, NCD-related curriculum signi cantly improved literacy on multiple dimensions among college-going youth in Gujarat, India. The curriculum was effective for students with diverse academic and socio-economic backgrounds. To our knowledge, this is the rst study in the Indian context to design an intervention using the health literacy framework and evaluate it using a randomized design. We, therefore, compared our ndings with health education intervention studies that aimed at improving NCD awareness among youth. Gavaravarapu et al. 22 carried out an intervention using a communication module to promote food label reading skills of school-going adolescents in Hyderabad, India. They reported 16.5% increase in food label reading skills in the intervention group (n =116), versus 1.85% increase in the comparison group (n = 59) (p<0.001).
Strengthening food label interpretation skills was one of the learning objectives of our intervention. Although we did not separately assess this component, our overall nding of an average increase of 27.52% (SD: 14.65) in the intervention group as compared to an average 8.99% (SD: 4.83) increase in the control group, is consistent with the ndings by Gavarvarapu et al.
Classroom-based health and nutrition education intervention among college-going volunteers (n = 351) in Odisha, India, reported a signi cant improvement of 11.36% in the average score of knowledge on nutrition and health in student volunteers after the intervention. Signi cant improvement in the percentage of student volunteers answering correctly was observed in most items related to knowledge about nutrition and lifestyle diseases 10 . Chaudhary et al. 23 reported an increase in the percentage of school-going adolescents who demonstrated knowledge about major risk factors of NCD ranging between 24 -47% after a single education session of 45 minutes. Our ndings showed a 75% increase in the proportion of students who scored 40% or above in the intervention group as compared to 22% in control group (p < 0.001).
A study by Shah et al. 24 reported signi cant improvement ranging from 7 -19% increase in the percentage of 15 -18 years old school students who answered key nutrition, physical activity and NCDrelated questions correctly after the intervention (n = 448) vs. before intervention (n = 539). Singhal et al. 25 reported a signi cant improvement in knowledge scores among 11th grade school students after a multicomponent intervention on nutrition and lifestyle education for behavior modi cation. Randomly selected intervention group (n = 99) showed improvement in knowledge related items as compared to the control group (n = 102).
Our study has several limitations. We did not measure the long-term impact of intervention on health literacy. It is possible that higher scores immediately after intervention are due to content remaining fresh in students' memory. Future studies should consider long-term follow-up of the study population with repeated measurements of health literacy scores at different time points. Another weakness is the empirical use of health literacy tool which has not been validated. We hope our work will stimulate other researchers to undertake this task. This is among very few studies globally, and to the best of our knowledge, rst study in the Indian context that addressed NCD-related literacy comprehensively in healthy populations in a college setting in a randomized trial. Our curriculum is also unique in its content and approach on disease prevention and health promotion with skills testing of measuring BP and blood sugar.
Our ndings can serve as a basis for the incorporation of health literacy modules in college curricula giving appropriate credits for both theoretical knowledge and skills testing. The ndings of our study is potentially a step towards policy change that supports and encourages health literacy in NCD in India and in other low and middle income countries. Singhal N, Misra A, Shah P, Gulati S. Effects of controlled school-based multi-component model of nutrition and lifestyle interventions on behavior modi cation, anthropometry and metabolic risk pro le of urban Asian Indian adolescents in North India. Eur J Clin Nutr 2010; 64(4):364-73.

Abbreviations
Non-communicable diseases (NCD), Health Literacy Skills (HLS) Declarations Con ict of interest: No nancial con ict of interest exists.
Funding: None IRB: The Institutional Ethics Committee (Indian Institute of Technology Gandhinagar) approved the study.
All the study participants signed the written informed consent form. The study was registered retrospectively on the ISRCTN registry (ISRCTN28814900).
Authorship: All authors contributed to conception, design, execution, analysis and interpretation of data. All authors were involved in drafting the article and revising it critically for important intellectual content, have read and approved the nal version of the manuscript. Tables   Tables 1-3