Dataset Information

Protocol for a cluster randomised trial evaluating a multifaceted intervention starting preconceptionally-Early Interventions to Support Trajectories for Healthy Life in India (EINSTEIN): a Healthy Life Trajectories Initiative (HeLTI) Study.

ABSTRACT:

Introduction

The Healthy Life Trajectories Initiative is an international consortium comprising four harmonised but independently powered trials to evaluate whether an integrated intervention starting preconceptionally will reduce non-communicable disease risk in their children. This paper describes the protocol of the India study.

Methods and analysis

The study set in rural Mysore will recruit ~6000 married women over the age of 18 years. The village-based cluster randomised design has three arms (preconception, pregnancy and control; 35 villages per arm). The longitudinal multifaceted intervention package will be delivered by community health workers and comprise: (1) measures to optimise nutrition; (2) a group parenting programme integrated with cognitive-behavioral therapy; (3) a lifestyle behaviour change intervention to support women to achieve a diverse diet, exclusive breast feeding for the first 6 months, timely introduction of diverse and nutritious infant weaning foods, and adopt appropriate hygiene measures; and (4) the reduction of environmental pollution focusing on indoor air pollution and toxin avoidance.The primary outcome is adiposity in children at age 5 years, measured by fat mass index. We will report on a host of intermediate and process outcomes. We will collect a range of biospecimens including blood, urine, stool and saliva from the mothers, as well as umbilical cord blood, placenta and specimens from the offspring.An intention-to-treat analysis will be adopted to assess the effect of interventions on outcomes. We will also undertake process and economic evaluations to determine scalability and public health translation.

Ethics and dissemination

The study has been approved by the institutional ethics committee of the lead institute. Findings will be published in peer-reviewed journals. We will interact with policy makers at local, national and international agencies to enable translation. We will also share the findings with the participants and local community through community meetings, newsletters and local radio.

Trial registration number

ISRCTN20161479, CTRI/2020/12/030134; Pre-results.

SUBMITTER: Kumaran K

PROVIDER: S-EPMC7888364 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

Protocol for a cluster randomised trial evaluating a multifaceted intervention starting preconceptionally-Early Interventions to Support Trajectories for Healthy Life in India (EINSTEIN): a Healthy Life Trajectories Initiative (HeLTI) Study.

Kumaran Kalyanaraman K Krishnaveni Ghattu V GV Suryanarayana Kumar Gavali KG Prasad Manohar Prabhu MP Belavendra Antonisamy A Atkinson Stephanie S Balasubramaniam Ramaswamy R Bandsma Robert H J RHJ Bhutta Zulfiqar A ZA Chandak Giriraj Ratan GR Comelli Elena M EM Davidge Sandra T ST Dennis Cindy-Lee CL Hammond Geoffrey L GL Jha Prabhat P Joseph K S KS Joshi Sadhana R SR Krishna Murali M Lee Kang K Lye Stephen S McGowan Patrick P Nepomnaschy Pablo P Padvetnaya Vivek V Pyne Saumyadipta S Sachdev Harshpal Singh HS Sahariah Sirazul Ameen SA Singhal Nalini N Trasler Jacquetta J Yajnik Chittaranjan S CS Baird Janis J Barker Mary M Martin Marie-Claude MC Husain Nusrat N Sellen Daniel D Fall Caroline H D CHD Shah Prakesh S PS Matthews Stephen G SG

BMJ open 20210216 2

<h4>Introduction</h4>The Healthy Life Trajectories Initiative is an international consortium comprising four harmonised but independently powered trials to evaluate whether an integrated intervention starting preconceptionally will reduce non-communicable disease risk in their children. This paper describes the protocol of the India study.<h4>Methods and analysis</h4>The study set in rural Mysore will recruit ~6000 married women over the age of 18 years. The village-based cluster randomised desi ...[more]

PMID: 33593789

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Project description:BackgroundIn evaluating technology-based behaviour change interventions, it is increasingly important to have a monitoring plan for intervention fidelity. It is important to maintain intervention fidelity to ensure that the theory-based intervention that is being tested is what causes the observed changes, particularly for eHealth behaviour change interventions. In this protocol, we outline the intervention fidelity and monitoring protocol for Healthy Life Trajectory Initiative (HeLTI) Canada, a randomized controlled trial evaluating the effect of a preconception-early childhood technology-based intervention delivered by public health nurses among pregnancy-planning women and their partners to optimize child growth and development.MethodsThe HeLTI Canada fidelity protocol is based on the National Institutes of Health Behaviour Change Consortium (NIH BCC) Treatment Fidelity Framework, outlining the following components of intervention fidelity: study design, provider training, intervention delivery, intervention receipt, and intervention enactment. The intervention fidelity components and associated monitoring strategies were developed to align with the HeLTI Canada approach. Strategies for intervention fidelity monitoring include a pre-post written evaluation of training, standardization of provider training, use and monitoring of activity logs, and intervention session checklists. Possible challenges to intervention fidelity include provider turnover due to the length of the trial and lack of ability to directly monitor participant behaviour change in real-life settings. Details about intervention fidelity monitoring are provided in detail. The study launched in January 2021 and is currently recruiting.DiscussionUsing the NIH BCC Treatment Fidelity Framework, HeLTI Canada has a robust framework for monitoring and reporting intervention fidelity to improve intervention validity, ability to assess intervention effectiveness, and transparency.Trial registrationISRCN ISRCTN13308752 . Registered on February 29, 2019.

Project description:IntroductionDespite the importance of intervention fidelity in interpreting the outcomes of complex public health interventions, there is a lack of both reporting fidelity trial protocols and uniformity. In evaluating complex, adaptable/pragmatic interventions in resource-strapped settings with systemic issues, unique challenges to intervention adherence and monitoring are introduced, increasing the importance of a fidelity protocol. We aim to describe the intervention fidelity and monitoring protocol for the Healthy Life Trajectories Initiative (HeLTI) South Africa, a complex four-phase intervention set in urban Soweto, starting preconceptionally and continuing through to pregnancy, infancy, and early childhood to improve the health of young women and reduce the intergenerational risk of obesity.MethodsThe HeLTI SA fidelity protocol was based on the NIH Behaviour Change Consortium (NIH BCC) Treatment Fidelity Framework, outlining the following components of intervention fidelity: study design, provider training, intervention delivery, intervention receipt, and intervention enactment. Context-specific fidelity challenges were identified. The intervention fidelity components and associated monitoring strategies were developed to align with HeLTI SA. Strategies for fidelity monitoring include, amongst others, qualitative process evaluation methods, reviewing observed and recorded intervention sessions, monitoring of activity logs, standardized training, and intervention session checklists. Possible challenges to fidelity and fidelity monitoring include high provider turnover, lack of qualification amongst providers, difficulty tracing participants for follow-up sessions, participant health literacy levels, and the need to prioritize participants' non-health-related challenges. Solutions proposed include adapting intervention delivery methods, recruitment methods, and provider training methods.DiscussionThe NIH BCC Treatment Fidelity Framework provided a solid foundation for reporting intervention fidelity across settings to improve intervention validity, ability to assess intervention effectiveness, and transparency. However, context-specific challenges to fidelity (monitoring) were identified, and transparency around such challenges and possible solutions in low- and middle-income settings could help foster solutions to improve adherence, reporting, and monitoring of intervention fidelity in this setting.Trial registrationPan African Clinical Trials Registry PACTR201903750173871 . Registered on 27 March 2019.

Project description:IntroductionSouth Africa's evolving burden of disease is challenging due to a persistent infectious disease, burgeoning obesity, most notably among women and rising rates of non-communicable diseases (NCDs). With two thirds of women presenting at their first antenatal visit either overweight or obese in urban South Africa (SA), the preconception period is an opportunity to optimise health and offset transgenerational risk of both obesity and NCDs.Methods and analysisBukhali is the first individual randomised controlled trial in Africa to test the efficacy of a complex continuum of care intervention and forms part of the Healthy Life Trajectories Initiative (HeLTI) consortium implementing harmonised trials in Canada, China, India and SA. Starting preconception and continuing through pregnancy, infancy and childhood, the intervention is designed to improve nutrition, physical and mental health and health behaviours of South African women to offset obesity-risk (adiposity) in their offspring. Women aged 18-28 years (n=6800) will be recruited from Soweto, an urban-poor area of Johannesburg. The primary outcome is dual-energy X-ray absorptiometry derived fat mass index (fat mass divided by height2) in the offspring at age 5 years. Community health workers will deliver the intervention randomly to half the cohort by providing health literacy material, dispensing a multimicronutrient supplement, providing health services and feedback, and facilitating behaviour change support sessions to optimise: (1) nutrition, (2) physical and mental health and (3) lay the foundations for healthier pregnancies and early child development.Ethics and disseminationEthical approval has been obtained from the Human Ethics Research Committee University of the Witwatersrand, Johannesburg, South Africa (M1811111), the University of Toronto, Canada (19-0066-E) and the WHO Ethics Committee (ERC.0003328). Data and biological sample sharing policies are consistent with the governance policy of the HeLTI Consortium (https://helti.org) and South African government legislation (POPIA). The recruitment and research team will obtain informed consent.Trial registrationThis trial is registered with the Pan African Clinical Trials Registry (https://pactr.samrc.ac.za) on 25 March 2019 (identifier: PACTR201903750173871).Protocol version20 March 2022 (version #4). Any protocol amendments will be communicated to investigators, Institutional Review Board (IRB)s, trial participants and trial registries.

Project description:BackgroundThe ubiquity of smartphones and mobile devices in the general population presents an unprecedented opportunity for preventative health. Not surprisingly, the use of electronic health (eHealth) resources accessed through mobile devices in clinical trials is becoming more prevalent; the selection, screening, and collation of quality eHealth resources is necessary to clinical trials using these technologies. However, the constant creation and turnover of new eHealth resources can make this task difficult. Although syntheses of eHealth resources are becoming more common, their methodological and reporting quality require improvement so as to be more accessible to nonexperts. Further, there continues to be significant variation in quality criteria employed for assessment, with no clear method for developing the included criteria. There is currently no single existing framework that addresses all six dimensions of mobile health app quality identified in Agarwal et al's recent scoping review (ie, basic descriptions of the design and usage of the resource; technical features and accessibility; health information quality; usability; evidence of impact; and user engagement and behavior change). In instances where highly systematic tactics are not possible (due to time constraints, cost, or lack of expertise), there may be value in adopting practical and pragmatic approaches to helping researchers and clinicians identify and disseminate e-resources.ObjectiveThe study aimed to create a set of guidelines (ie, a checklist) to aid the members of the Healthy Life Trajectories Initiative (HeLTI) Canada trial-a preconception randomized controlled clinical trial to prevent child obesity-to assist their efforts in searching, identifying, screening, and including selected eHealth resources for participant use in the study intervention.MethodsA framework for searching, screening, and selecting eHealth resources was adapted from the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) checklist for systematic and scoping reviews to optimize the rigor, clarity, and transparency of the process. Details regarding searching, selecting, extracting, and assessing quality of eHealth resources are described.ResultsThis study resulted in the systematic development of a checklist consisting of 12 guiding principles, organized in a chronological versus priority sequence to aid researchers in searching, screening, and assessing the quality of various eHealth resources.ConclusionsThe eHealth Resource Checklist will assist researchers in navigating the eHealth resource space by providing a mechanism to detail their process of developing inclusion criteria, identifying search location, selecting and reviewing evidence, extracting information, evaluating the quality of the evidence, and synthesizing the extracted evidence. The overarching goal of this checklist is to provide researchers or generalists new to the eHealth field with a tool that balances pragmatism with rigor and that helps standardize the process of searching and critiquing digital material-a particularly important aspect given the recent explosion of and reliance on eHealth resources. Moreover, this checklist may be useful to other researchers and practitioners developing similar health interventions.

Project description:IntroductionChildhood overweight and obesity (OWO) is a primary global health challenge. Childhood OWO prevention is now a public health priority in China. The Sino-Canadian Healthy Life Trajectories Initiative (SCHeLTI), one of four trials being undertaken by the international HeLTI consortium, aims to evaluate the effectiveness of a multifaceted, community-family-mother-child intervention on childhood OWO and non-communicable diseases risk.Methods and analysisThis is a multicentre, cluster-randomised, controlled trial conducted in Shanghai, China. The unit of randomisation is the service area of Maternal Child Health Units (N=36). We will recruit 4500 women/partners/families in maternity and district level hospitals. Participants in the intervention group will receive a multifaceted, integrated package of health promotion interventions beginning in preconception or in the first trimester of pregnancy, continuing into infancy and early childhood. The intervention, which is centred on a modified motivational interviewing approach, will target early-life maternal and child risk factors for adiposity. Through the development of a biological specimen bank, we will study potential mechanisms underlying the effects of the intervention. The primary outcome for the trial is childhood OWO (body mass index for age ≥85th percentile) at 5 years of age, based on WHO sex-specific standards. The study has a power of 0.8 (α=0.05) to detect a 30% risk reduction in the proportion of children with OWO at 5 years of age, from 24.4% in the control group to 17% in the intervention group. Recruitment was launched on 30 August 2018 for the pilot study and 10 January 2019 for the formal study.Ethics and disseminationThe study has been approved by the Medical Research Ethics Committee of the International Peace Maternity and Child Health Hospital in Shanghai, China, and the Research Ethics Board of the Centre Intégré Universitaire de Santé et Services Sociaux de l'Estrie-CHUS in Sherbrooke, Canada. Data sharing policies are consistent with the governance policy of the HeLTI consortium and government legislation.Trial registration numberChiCTR1800017773.Protocol versionNovember 11, 2020 (Version #5).

Project description:BackgroundSocial messaging strategies such as SMS text messaging and radio are promising avenues for health promotion and behavior change in low- to middle-income settings. However, evidence of their acceptability, feasibility, and impact in the context of young women's health and micronutrient deficiencies is lacking.ObjectiveThis study aimed to evaluate the feasibility of an automated 2-way text messaging intervention nested in an ongoing preconception health trial, the Healthy Life Trajectories Initiative (HeLTI; HeLTI Bukhali) in Soweto, South Africa. Second, we aimed to evaluate the acceptability of a health promotion radio serial, which aired concurrently in the region.MethodsIn this feasibility study, 120 participants enrolled in HeLTI Bukhali between November 2020 and February 2021 received the 6-month 2-way text messaging intervention. Quantitative and qualitative data on intervention acceptability, usability, interaction, perceived benefit, and fidelity were collected during 5 focus group discussions (FGDs) and from study data logs. During the FGDs, data were collected on the acceptability of the radio serial. Following the text messaging intervention, capillary hemoglobin levels were assessed, and a participant questionnaire provided information on adherence and attitudes toward supplements. The text messaging control group comprised the first 120 women recruited from November 2019 to February 2020, who received the Bukhali intervention but not the text messages. Statistical significance testing and a linear mixed model were used for indicative effect comparisons between the text message-receiving and control groups.ResultsThe text messaging intervention was found to be acceptable and to have perceived benefits, including being reminded to take supplements, gaining knowledge, and feeling supported by the study team. The use of the 2-way text messaging reply function was limited, with only a 10.8% (13/120) response rate by week 24. Barriers to replying included a lack of interest or phone credit and technical issues. Regarding the indicative effect, participants receiving the text messages had higher self-reported adherence at follow-up than the text messaging control group (42/63, 67% vs 33/85, 39% taking supplements every time; P=.02), and altitude-adjusted hemoglobin increased more between baseline and follow-up in the SMS text message-receiving group than in the text messaging control group (1.03, 95% CI 0.49-1.57; P<.001). The radio serial content was acceptable, although few participants reported exposure before the FGD.ConclusionsWomen reported that the text messaging intervention was useful and described the benefits of receiving the messages. Examination of hemoglobin status indicated a promising beneficial effect of text messaging support on adherence to micronutrient supplementation, requiring further exploration through randomized controlled studies. Health promotion through radio and text messages were both found to be acceptable, although more research into the radio serial reach among young women is needed.Trial registrationPan African Clinical Trials Registry (PACTR) PACTR201903750173871; https://tinyurl.com/4x6n32ff.

Dataset Information

Protocol for a cluster randomised trial evaluating a multifaceted intervention starting preconceptionally-Early Interventions to Support Trajectories for Healthy Life in India (EINSTEIN): a Healthy Life Trajectories Initiative (HeLTI) Study.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Protocol for a cluster randomised trial evaluating a multifaceted intervention starting preconceptionally-Early Interventions to Support Trajectories for Healthy Life in India (EINSTEIN): a Healthy Life Trajectories Initiative (HeLTI) Study.

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