Dataset Information

A protocol for monitoring fidelity of a preconception-life course intervention in a middle-income setting: the Healthy Life Trajectories Initiative (HeLTI), South Africa.

ABSTRACT:

Introduction

Despite 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.

Methods

The 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.

Discussion

The 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 registration

Pan African Clinical Trials Registry PACTR201903750173871 . Registered on 27 March 2019.

SUBMITTER: Soepnel LM

PROVIDER: S-EPMC9449293 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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Publications

A protocol for monitoring fidelity of a preconception-life course intervention in a middle-income setting: the Healthy Life Trajectories Initiative (HeLTI), South Africa.

Soepnel Larske M LM Draper Catherine E CE Mabetha Khuthala K Dennis Cindy-Lee CL Prioreschi Alessandra A Lye Stephen S Norris Shane A SA

Trials 20220906 1

<h4>Introduction</h4>Despite 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 moni ...[more]

PMID: 36068565

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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: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:IntroductionThe 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 analysisThe 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 disseminationThe 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 numberISRCTN20161479, CTRI/2020/12/030134; Pre-results.

Project description:BackgroundResearch on menstrual health is required to understand menstrual needs and generate solutions to improve health, wellbeing, and productivity. The identification of research priorities will help inform where to invest efforts and resources.ObjectivesTo identify research priorities for menstrual health across the life-course, in consultation with a range of stakeholder groups from a variety of geographic regions, and to identify if menstrual health research priorities varied by expertise.MethodsA modified version of the Child Health and Nutrition Research Initiative approach was utilized to reach consensus on a set of research priorities. Multisector stakeholders with menstrual health expertise, identified through networks and the literature, were invited to submit research questions through an online survey. Responses were consolidated, and individuals were invited to rank these questions based on novelty, potential for intervention, and importance/impact. Research priority scores were calculated and evaluated by participants' characteristics.ResultsEighty-two participants proposed 1135 research questions, which were consolidated into 94 unique research questions. The mean number of questions did not differ between low- and middle-income country (LMIC) and high-income country (HIC) participants, but significantly more questions were raised by participants with expertise in mental health and WASH. Sixty-six participants then ranked these questions. The top ten-ranked research questions included four on 'understanding the problem', four on 'designing and implementing interventions', one on 'integrating and scaling up', and one on 'measurement'. Indicators for the measurement of adequate menstrual health over time was ranked the highest priority by all stakeholders. Top ten-ranked research questions differed between academics and non-academics, and between participants from HICs and LMICs, reflecting differences in needs and knowledge gaps.ConclusionsA list of ranked research priorities was generated through a consultative process with stakeholders across LMICs and HICs which can inform where to invest efforts and resources.

Dataset Information

A protocol for monitoring fidelity of a preconception-life course intervention in a middle-income setting: the Healthy Life Trajectories Initiative (HeLTI), South Africa.

Introduction

Methods

Discussion

Trial registration

Publications

A protocol for monitoring fidelity of a preconception-life course intervention in a middle-income setting: the Healthy Life Trajectories Initiative (HeLTI), South Africa.

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