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Protocol for a cluster randomised controlled trial on information technology-enabled nutrition intervention among urban adults in Chandigarh (India): SMART eating trial.

ABSTRACT: Nutrition is an important determinant of health. At present, nutrition programs in India mainly emphasize improving maternal and child nutrition. Adult nutrition has not received due attention, though diseases like hypertension and diabetes are largely preventable through changes in dietary and physical activity behaviour. Little is known about the best approaches to improve dietary behaviours, especially the role of modern information technology (IT) in health education. We describe the protocol of the SMART Eating (Small, Measurable and Achievable dietary changes by Reducing fat, sugar and salt consumption and Trying different fruits and vegetables) health promotion intervention. A Cluster Randomised Controlled Trial will evaluate the effect of an IT-enabled intervention on nutrition behaviour among urban adults of Chandigarh, India. Formative research using a qualitative exploratory approach was undertaken to inform the intervention. The IT-enabled intervention programme includes website development, Short Message Service (SMS), e-mail reminders and interactive help by mobile and landline phones. The IT-enabled intervention will be compared to the traditional nutrition education program of distributing pamphlets in the control group. The primary outcome will be the percentage of study participants meeting the dietary intake guidelines of the National Institute of Nutrition, Hyderabad, India and the change in intake of fat, sugar, salt, fruit and vegetables after the intervention. The difference in differences method will be used to determine the net change in dietary intakes resulting from the interventions. Measurements will be made at baseline and at 6 months post-intervention, using a food frequency questionnaire. The formative research led to the development of a comprehensive intervention, focusing on five dietary components and using multi-channel communication approach including the use of IT to target urban North Indians from diverse socio-economic backgrounds. The Cluster Randomised Controlled Trial design is suitable for evaluating the effectiveness of this IT-enabled intervention for dietary behaviour change.

SUBMITTER: Kaur J

PROVIDER: S-EPMC5795704 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Protocol for a cluster randomised controlled trial on information technology-enabled nutrition intervention among urban adults in Chandigarh (India): SMART eating trial.

Kaur Jasvir J Kaur Manmeet M Webster Jacqui J Kumar Rajesh R

Global health action 20180101 1

Nutrition is an important determinant of health. At present, nutrition programs in India mainly emphasize improving maternal and child nutrition. Adult nutrition has not received due attention, though diseases like hypertension and diabetes are largely preventable through changes in dietary and physical activity behaviour. Little is known about the best approaches to improve dietary behaviours, especially the role of modern information technology (IT) in health education. We describe the protoco ...[more]

PMID: 29370744

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Project description:BACKGROUND:Unhealthy dietary behaviour-high intake of fat, sugar, and salt, and low intake of fruits and vegetables-is a major risk factor for chronic diseases. There is a lack of evidence-based interventions to promote healthy dietary intake among Indian populations. Therefore, we tested the effectiveness of an information technology-enabled 'SMART Eating' intervention to reduce the intake of fat, sugar and salt, and to increase the intake of fruits and vegetables. METHODS:In Chandigarh, a North Indian city, a cluster randomized controlled trial was implemented in twelve geographical clusters, based on the type of housing (i.e., LIG: Low-income group; MIG; Middle-income group, and HIG: High-income group-a proxy for socio-economic status). Computer-generated randomization was used to allocate clusters to intervention and comparison arms after pairing on the basis of socioeconomic status and geographical distance between clusters. The sample size was 366 families per arm (N = 732). One adult per family was randomly selected as an index case to measure the change in the outcomes. For behaviour change, a multi-channel communication approach was used, which included information technology-short message service (SMS), email, social networking app and 'SMART Eating' website, and interpersonal communication along with distribution of a 'SMART Eating' kit-kitchen calendar, dining table mat, and measuring spoons. The intervention was implemented at the family level over a period of six months. The comparison group received pamphlets on nutrition education. Outcome measurements were made at 0 and 6 months post-intervention at the individual level. Primary outcomes were changes in mean dietary intakes of fat, sugar, salt, and fruit and vegetables. Secondary outcomes included changes in body mass index (BMI), blood pressure, haemoglobin, fasting plasma glucose (FPG), and serum lipids. Mixed-effects linear regression models were used to determine the net change in the outcomes in the intervention group relative to the comparison group. RESULTS:Participants' mean age was 53 years, a majority were women (76%), most were married (90%) and 51% had completed a college degree. All families had mobile phones, and more than 90% of these families had access to Internet through mobile phones. The intervention group had significant net mean changes of -12.5 g/day (p<0.001), -11.4 g/day (p<0.001), -0.5 g/day (p<0.001), and +71.6 g/day (p<0.001) in the intake of fat, sugar, salt, and fruit and vegetables, respectively. Similarly, significant net changes occurred for secondary outcomes: BMI -0.25 kg/m2, diastolic blood pressure -2.77 mm Hg, FPG -5.7 mg/dl, and triglycerides -24.2mg/dl. The intervention had no effect on haemoglobin, systolic blood pressure, low-density lipoprotein cholesterol, or high-density lipoprotein cholesterol. CONCLUSION:The IT-enabled 'SMART Eating' intervention was found to be effective in reducing fat, sugar, and salt intake, and increasing fruit and vegetable consumption among urban adults from diverse socio-economic backgrounds. TRIAL REGISTRATION:Clinical Trial Registry of India CTRI/2016/11/007457.

Project description:BackgroundmHealth technology holds promise for improving the effectiveness of frontline health workers (FLWs), who provide most health-related primary care services, especially reproductive, maternal, newborn, child health and nutrition services (RMNCHN), in low-resource - especially hard-to-reach - settings. Data are lacking, however, from rigorous evaluations of mHealth interventions on delivery of health services or on health-related behaviors and outcomes.MethodsThe Information Communication Technology-Continuum of Care Service (ICT-CCS) tool was designed for use by community-based FLWs to increase the coverage, quality and coordination of services they provide in Bihar, India. It consisted of numerous mobile phone-based job aids aimed to improve key RMNCHN-related behaviors and outcomes. ICT-CCS was implemented in Saharsa district, with cluster randomization at the health sub-center level. In total, evaluation surveys were conducted with approximately 1100 FLWs and 3000 beneficiaries who had delivered an infant in the previous year in the catchment areas of intervention and control health sub-centers, about half before implementation (mid-2012) and half two years afterward (mid-2014). Analyses included bivariate and difference-in-difference analyses across study groups.ResultsThe ICT-CCS intervention was associated with more frequent coordination of AWWs with ASHAs on home visits and greater job confidence among ASHAs. The intervention resulted in an 11 percentage point increase in FLW antenatal home visits during the third trimester (P = 0.04). In the post-implementation period, postnatal home visits during the first week were increased in the intervention (72%) vs the control (60%) group (P < 0.01). The intervention also resulted in 13, 12, and 21 percentage point increases in skin-to-skin care (P < 0.01), breastfeeding immediately after delivery (P < 0.01), and age-appropriate complementary feeding (P < 0.01). FLW supervision and other RMNCHN behaviors were not significantly impacted.ConclusionsImportant improvements in FLW home visits and RMNCHN behaviors were achieved. The ICT-CCS tool shows promise for facilitating FLW effectiveness in improving RMNCHN behaviors.

Project description:BackgroundThe recent Australian National Agenda for Eating Disorders highlights the role technology can play in improving accessibility and service development through web-based prevention, early access pathways, self-help, and recovery assistance. However, engagement with the eating disorders community to co-design, build, and evaluate these much-needed technology solutions through participatory design processes has been lacking and, until recently, underresourced.ObjectiveThis study aims to customize and configure a technology solution for a nontraditional (web-based, phone, email) mental health service that provides support for eating disorders and body image issues through the use of participatory design processes.MethodsParticipants were recruited chiefly through the Butterfly National Helpline 1800 ED HOPE (Butterfly's National Helpline), an Australian-wide helpline supporting anyone concerned by an eating disorder or body image issue. Participants included individuals with lived experience of eating disorders and body image issues, their supportive others (such as family, health professionals, support workers), and staff of the Butterfly Foundation. Participants took part in participatory design workshops, running up to four hours, which were held nationally in urban and regional locations. The workshop agenda followed an established process of discovery, evaluation, and prototyping. Workshop activities included open and prompted discussion, reviewing working prototypes, creating descriptive artifacts, and developing user journeys. Workshop artifacts were used in a knowledge translation process, which identified key learnings to inform user journeys, user personas, and the customization and configuration of the InnoWell Platform for Butterfly's National Helpline. Further, key themes were identified using thematic techniques and coded in NVivo 12 software.ResultsSix participatory design workshops were held, of which 45 participants took part. Participants highlighted that there is a critical need to address some of the barriers to care, particularly in regional and rural areas. The workshops highlighted seven overarching qualitative themes: identified barriers to care within the current system; need for people to be able to access the right care anywhere, anytime; recommendations for the technological solution (ie, InnoWell Platform features and functionality); need for communication, coordination, and integration of a technological solution embedded in Butterfly's National Helpline; need to consider engagement and tone within the technological solution; identified challenges and areas to consider when implementing a technological solution in the Helpline; and potential outcomes of the technological solution embedded in the Helpline relating to system and service reform. Ultimately, this technology solution should ensure that the right care is provided to individuals the first time.ConclusionsOur findings highlight the value of actively engaging stakeholders in participatory design processes for the customization and configuration of new technologies. End users can highlight the critical areas of need, which can be used as a catalyst for reform through the implementation of these technologies in nontraditional services.

Project description:INTRODUCTION:The objective of this study was to examine changes in hemoglobin A1c (HbA1c), anti-diabetic medication use, insulin resistance, and other ambulatory glucose profile metrics between baseline and after 90 days of participation in the Twin Precision Nutrition (TPN) Program enabled by Digital Twin Technology. METHODS:This was a retrospective study of patients with type 2 diabetes who participated in the TPN Program and had at least 3 months of follow-up. The TPN machine learning algorithm used daily continuous glucose monitor (CGM) and food intake data to provide guidelines that would enable individual patients to avoid foods that cause blood glucose spikes and to replace them with foods that do not produce spikes. Physicians with access to daily CGM data titrated medications and monitored patient conditions. RESULTS:Of the 89 patients who initially enrolled in the TPN Program, 64 patients remained in the program and adhered to it for at least 90 days; all analyses were performed on these 64 patients. At the 90-day follow-up assessment, mean (±?standard deviation) HbA1c had decreased from 8.8?±?2.2% at baseline by 1.9 to 6.9?±?1.1%, mean weight had decreased from 79.0?±?16.2 kg at baseline to 74.2?±?14.7 kg, and mean fasting blood glucose had fallen from 151.2 ±?45.0 mg/dl at baseline to 129.1?±?36.7 mg/dl. Homeostatic model assessment of insulin resistance (HOMA-IR) had decreased by 56.9% from 7.4?±?3.5 to 3.2?±?2.8. At the 90-day follow-up assessment, all 12 patients who were on insulin had stopped taking this medication; 38 of the 56 patients taking metformin had stopped metformin; 26 of the 28 patients on dipeptidyl peptidase-4 (DPP-4) inhibitors discontinued DPP-4 inhibitors; all 13 patients on alpha-glucosidase inhibitors discontinued these inhibitors; all 34 patients on sulfonylureas were able to stop taking these medications; two patients stopped taking pioglitazone; all ten patients on sodium-glucose cotransporter-2 (SGLT2) inhibitors stopped taking SGLT2 inhibitors; and one patient stopped taking glucagon-like peptide-1 analogues. CONCLUSION:The results provide evidence that daily precision nutrition guidance based on CGM, food intake data, and machine learning algorithms can benefit patients with type 2 diabetes. Adherence for 3 months to the TPN Program resulted in patients achieving a 1.9 percentage point decrease in HbA1c, a 6.1% drop in weight, a 56.9% reduction in HOMA-IR, a significant decline in glucose time below range, and, in most patients, the elimination of diabetes medication use.

Project description:IntroductionIn India about 95% of individuals who need treatment for common mental disorders like depression, stress and anxiety and substance use are unable to access care. Stigma associated with help seeking and lack of trained mental health professionals are important barriers in accessing mental healthcare. Systematic Medical Appraisal, Referral and Treatment (SMART) Mental Health integrates a community-level stigma reduction campaign and task sharing with the help of a mobile-enabled electronic decision support system (EDSS)-to reduce psychiatric morbidity due to stress, depression and self-harm in high-risk individuals. This paper presents and discusses the protocol for process evaluation of SMART Mental Health.Methods and analysisThe process evaluation will use mixed quantitative and qualitative methods to evaluate implementation fidelity and identify facilitators of and barriers to implementation of the intervention. Case studies of six intervention and two control clusters will be used. Quantitative data sources will include usage analytics extracted from the mHealth platform for the trial. Qualitative data sources will include focus group discussions and interviews with recruited participants, primary health centre doctors, community health workers (Accredited Social Health Activits) who participated in the project and local community leaders. The design and analysis will be guided by Medical Research Council framework for process evaluations, the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework, and the normalisation process theory.Ethics and disseminationThe study has been approved by the ethics committee of the George Institute for Global Health, India and the Institutional Ethics Committee, All India Institute of Medical Sciences (AIIMS), New Delhi. Findings of the study will be disseminated through peer-reviewed publications, stakeholder meetings, digital and social media platforms.Trial registration numberCTRI/2018/08/015355.

Project description:BackgroundCholera infection continues to be a threat to global public health. The current cholera pandemic associated with Vibrio cholerae El Tor has now been ongoing for over half a century.Methodology/principal findingsThirty-eight V. cholerae El Tor isolates associated with a cholera outbreak in 2009 from the Chandigarh region of India were characterised by a combination of microbiology, molecular typing and whole-genome sequencing. The genomic analysis indicated that two clones of V. cholera circulated in the region and caused disease during this time. These clones fell into two distinct sub-clades that map independently onto wave 3 of the phylogenetic tree of seventh pandemic V. cholerae El Tor. Sequence analyses of the cholera toxin gene, the Vibrio seventh Pandemic Island II (VSPII) and SXT element correlated with this phylogenetic position of the two clades on the El Tor tree. The clade 2 isolates, characterized by a drug-resistant profile and the expression of a distinct cholera toxin, are closely related to the recent V. cholerae isolated elsewhere, including Haiti, but fell on a distinct branch of the tree, showing they were independent outbreaks. Multi-Locus Sequence Typing (MLST) distinguishes two sequence types among the 38 isolates, that did not correspond to the clades defined by whole-genome sequencing. Multi-Locus Variable-length tandem-nucleotide repeat Analysis (MLVA) identified 16 distinct clusters.Conclusions/significanceThe use of whole-genome sequencing enabled the identification of two clones of V. cholerae that circulated during the 2009 Chandigarh outbreak. These clones harboured a similar structure of ICEVchHai1 but differed mainly in the structure of CTX phage and VSPII. The limited capacity of MLST and MLVA to discriminate between the clones that circulated in the 2009 Chandigarh outbreak highlights the value of whole-genome sequencing as a route to the identification of further genetic markers to subtype V. cholerae isolates.

Dataset Information

Protocol for a cluster randomised controlled trial on information technology-enabled nutrition intervention among urban adults in Chandigarh (India): SMART eating trial.

Publications

Protocol for a cluster randomised controlled trial on information technology-enabled nutrition intervention among urban adults in Chandigarh (India): SMART eating trial.

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