How the COVID-19 pandemic and cost-of-living crisis shaped reach and engagement in the ECAIL trial targeting socially disadvantaged families: an interdisciplinary implementation study
1Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Centre for Research in Epidemiology and Statistics, Paris, France
2Université Lille, Inserm, CHU Lille, CIC 1403 - Clinical Investigation Center, Lille, France
3Université Lille, Inserm, CHU Lille, U1286, INFINITE - Institute for Translational Research in Inflammation, Lille, France
4Université Lille, Women and Newborn Mother Unit, CHU Lille, EA 2694, METRICS, Evaluation of Health Technologies and Medical Practices, Lille, France
5Association Programme Malin, Research and Content Department, Paris, France
6CHU Lille, Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Lille, France
7Sorbonne Université, Universitary Department of Midwifery, Paris, France
*Corresponding author: Sandrine Lioret; sandrine.lioret@inserm.frAbstract
Background
The ECAIL trial, launched in 2017, targets hard-to-reach families and evaluates a multicomponent childhood obesity prevention intervention. At a maternity hospital in Lille, France, healthcare providers screened pregnant women experiencing social vulnerability, and dietitians delivered a home-based intervention until age 2. The COVID-19 pandemic led to a six-month suspension in 2020. This study compared eligibility and participation before the pandemic and after resumption, and examined how the pandemic and subsequent cost-of-living crisis shaped implementation and reach.
Methods
We analyzed 5,744 eligibility questionnaires distributed at the maternity ward. Inclusion criteria included ≥1 indicator of social vulnerability (e.g., socioeconomic disadvantage, precarious housing, or social isolation). To capture implementation experiences, a psychosocial researcher conducted a focus group with six dietitians delivering the intervention; it was recorded, transcribed, and analyzed thematically focusing on reach, acceptability, and adaptation.
Results
Eligibility increased from 29.7% (n=955) prepandemic to 33.6% (n=849) after resumption, while the distribution of vulnerability criteria remained similar across periods: 78.3% received social/medical benefits; employment was not the main source of household income for 58.7%; 24.4% experienced financial hardship; 14.7% reported social isolation; 6.0% lived in precarious housing; and 19.0% had three or more vulnerabilities. Participation among eligible women remained stable (24.6%; n=443). Qualitative findings indicated dietitians’ satisfaction and participants’ enthusiasm for the resumption of home visits, particularly in addressing social isolation. After resumption, the introduction of a pre-visit COVID-19 questionnaire reduced missed appointments. Converging qualitative and quantitative findings indicated sustained, and in some cases strengthened, provider engagement despite pandemic-related strain on hospital services.
Conclusions
This study shows that a complex intervention can maintain reach and acceptability through adaptive implementation under major contextual disruptions. The rapid resumption of home-based services emerged as a robust strategy for engaging and retaining socially disadvantaged families, highlighting the importance of flexible, context-sensitive approaches during social and economic crises.
Trial registration
Clinicaltrials.gov NCT03003117; registration date: 21/12/2016; https://clinicaltrials.gov/study/NCT03003117
Article notes
Competing Interest Statement
The authors have declared no competing interest.
Clinical Trial
Clinicaltrials.gov NCT03003117 registration date: 21/12/2016
Clinical Protocols
Funding Statement
Yes
Introduction
In 2020, the COVID-19 pandemic triggered a massive health crisis worldwide, accompanied by prolonged economic and social repercussions. Following the initial lifting of pandemic-related health restrictions and in the context of subsequent geopolitical shocks, including the invasion of Ukraine, energy and food prices surged across the Eurozone (1). Although governments implemented exceptional measures, this inflation reduced consumer purchasing power, especially among low-income households (2). In France, for example, according to the National Institute of Statistics and Economic Studies (Insee), the cost of the “food basket” rose more sharply for lower income households. This was partly because items like oils and other fatty products, representing a larger share of their food spending, were among the products most affected by inflation, with prices rising by about 30% in January 2023 compared with the previous year (3). Likewise, because transportation and housing make up a larger share of their consumption basket, these households were also more severely affected by rising energy prices (4). As a result, low-income households, who were already vulnerable before the shocks, were and continue to be disproportionately affected by these successive health and cost-of-living crises (5), illustrating a cumulative disadvantage often described as the poverty penalty (6). Moreover, the rise in poverty and food insecurity following the COVID-19 pandemic (7, 8) has further exacerbated social, economic, and health inequalities (9, 10).
Numerous studies have underscored the detrimental impact of the COVID-19 pandemic on health-related behaviors (such as physical activity, sedentary behaviors, and dietary intake), as well as on obesity and mental health in both adults and children (11–17). Far less attention, however, has been given to how such large-scale disruptions have affected the implementation of ongoing public health interventions, particularly those targeting socially disadvantaged populations. From an implementation science perspective, understanding how implementation outcomes such as reach, engagement, and fidelity are sustained, adapted, or disrupted under crisis conditions remains a critical gap in the literature (18). Frameworks such as RE-AIM highlight the importance of examining reach, adoption, and implementation processes alongside effectiveness, particularly for interventions targeting socially disadvantaged groups (19, 20) that are considered “hard-to-survey”, that is, populations who are not only difficult to sample, but also challenging to identify, reach, recruit, engage, and retain over time (21, 22).
We seek to address this gap by analyzing quantitative and qualitative data collected within the ongoing prEgnanCy and eArly Childhood nutrItion triaL (ECAIL), launched in 2017 in northern France (23). The overarching aim of ECAIL is to assess the effectiveness of a multilevel and multibehavioral intervention initiated during pregnancy that combines nutritional counseling with facilitated access to healthy foods at a reduced price, with the goal of promoting healthy lifestyle behaviors and preventing obesity in young children from underserved families. Building on an interdisciplinary and implementation-focused approach, the present study aims to (i) describe and compare eligibility and participation rates before the pandemic and after the trial resumed six months later, with particular attention to reach and its social patterning, and (ii) explore how the pandemic and subsequent cost-of-living crisis shaped the implementation of ECAIL, including adaptations to delivery and stakeholder engagement in the trial.
Methods
Study design and participants
ECAIL is an ongoing single-blind randomized controlled trial led by the French national institute for health and medical research (Inserm) and underway since 2017 in northern France to evaluate the effectiveness of an existing program, named Malin (24), delivered by trained dietitians. Beyond its evaluative design, ECAIL is also a participatory action research project (25), co-created with members of the Malin nonprofit association and its historical stakeholders, namely the French Red Cross and two French pediatric societies (the French Society of Pediatrics and the French Association for Ambulatory Pediatrics), in close collaboration with investigators from the Lille University Hospital and the Valenciennes Hospital. This co-creation process aimed to enhance the intervention’s contextual relevance, feasibility, and acceptability for socially disadvantaged families, as well as its integration into existing care pathways. More details about the ECAIL trial design, intervention components, and implementation procedures are provided in the published protocol (23).
Pregnant women were screened for eligibility during routine prenatal care at the maternity wards of Lille University Hospital (from March 2017 to April 2023; Fig 1), where 443 women were enrolled, and at Valenciennes Hospital. The present analysis focuses exclusively on the Lille site, as the Valenciennes center opened in June 2021, more than one year after the onset of COVID-19.
While waiting for their prenatal appointment, pregnant women were given an eligibility questionnaire (Supplementary document 1) by reception staff and completed it, covering all inclusion and exclusion criteria (Table 1). Healthcare providers (HCPs; e.g., midwives, nurses, or obstetricians) used this questionnaire to determine eligibility for the ECAIL trial. When a woman was deemed eligible, the HCP was expected, as part of the screening protocol, to contact a dietitian from the ECAIL implementation team by telephone. The dietitian then provided the woman and her partner (when present) with information about the study in person, immediately after the HCP appointment. Within the following week, the same dietitian contacted the eligible woman by telephone to assess her willingness to participate. If she agreed, an appointment was scheduled at her home (or another location of her choice) for the baseline visit during the third trimester of pregnancy. If the eligible woman declined participation, the dietitian recorded her reasons on the eligibility questionnaire.
When the HCP failed to call an ECAIL dietitian, he or she transmitted the questionnaire at a later time, and a dietitian then contacted the woman by telephone to provide study information. Women were then offered a one-week reflection period, followed by an additional call to discuss participation. Importantly, the provision of study information face to face by dietitians, rather than exclusively by telephone, served as an indirect indicator of HCP engagement with the screening procedure. Moreover, as part of the co-creation process, the eligibility questionnaire was co-designed, pilot-tested, and iteratively refined with HCPs, and monthly coordination meetings were used to identify barriers and collectively develop solutions to support implementation.
During the baseline home visit, the mother-to-be provided written consent for the participation of the mother-child dyad, randomization was performed, and the inclusion process was formalized. Subsequently, participating families were followed up by dietitians, first at the maternity ward shortly after delivery, and then through five additional home visits until the child’s second birthday, that is, at 3, 6, 12, 18, and 24 months.
Due to the COVID-19 pandemic, screening, inclusions, and home visits were suspended during the first national lockdown, which started on March 15, 2020 (Fig 1), when 140 families were actively under follow-up in the study. To enable the safe continuation of the intervention, implementation adaptations were introduced upon resumption. Home visits (June 2020) and screening/inclusions (September 2020) resumed under an adapted delivery protocol. Dietitians contacted participants by telephone before each home visit to administer a questionnaire assessing COVID-19 symptoms within the previous three weeks and recent contact with a confirmed case. Dietitians had the option to consult a physician to decide whether to proceed with the visit or postpone it for two weeks. Before the pandemic, dietitians typically sent a text message prior to visits without requiring participant confirmation; this pre-visit telephone contact was introduced after resumption. During home visits, dietitians were required to comply with protective measures, including wearing masks, practicing hand hygiene, and maintaining social distancing, and participants were requested to do the same. These adaptations allowed the intervention to be delivered while maintaining feasibility and in-person contact with families.
Data collection and measurements
Time periods
We defined two periods, namely prepandemic (March 2017 to March 2020; P0) and post-study resumption (September 2020 through April 2023). To capture temporal variation in implementation conditions, the post-resumption period was segmented into three periods of approximately one year (September-August) to reflect post-resumption yearly cycles; the final period was shorter due to the end of screening in April 2023 (Fig 1; P1, P2, and P3).
Indicators of implementation
Drawing on the RE-AIM framework, the following indicators were selected: eligibility and participation as indicators of Reach; delivery modalities as indicators of Implementation and Adoption (as they reflect HCP engagement in screening and referral); and follow-up completion and adaptations as indicators of Implementation (19, 20).
Eligibility
The eligibility rate was calculated as the number of eligible pregnant women (according to the responses collected from the eligibility questionnaires) divided by the number of eligibility questionnaires completed by pregnant women and returned to the ECAIL dietitians. As a proxy for implementation processes and provider engagement, the mode of study information delivery by dietitians to eligible women was categorized as either in person or by telephone.
Participation
The participation rate was calculated as the number of actual inclusions in the ECAIL trial divided by the number of eligible pregnant women. Non-participation was classified into four categories: women who were unreachable; screening failures (i.e., cases in which inclusion could not be completed, regardless of the women’s decision, due to timing constraints, pregnancy outcomes, or unforeseen exclusion criteria); refusals without stated reasons; and refusals with one or more reasons, recorded verbatim by ECAIL dietitians.
Follow-up
Based on the theoretical number of follow-up visits expected to take place from trial commencement to the end of the screening in April 2023, we calculated the rate of skipped visits. We also calculated the rate of failed visits, defined as cases in which the dietitian found nobody at the participant’s home, expressed as the number of failed visits divided by the number of trips made by dietitians.
Focus group
A researcher in psychosocial sciences (DP) conducted an in-person focus group in May 2023 at the Lille University Hospital with the complete ECAIL implementation team, comprising six dietitians (including the coordinator), to explore the impact of the COVID-19 pandemic on trial implementation. Written informed consent was obtained from each dietitian.
Several considerations guided the use of a focus group (26, 27). First, the COVID-19 pandemic substantially disrupted usual implementation conditions, warranting an in-depth qualitative assessment alongside quantitative indicators. Second, dietitians were identified a priori as the most relevant stakeholders for this analysis, given their central role and sustained engagement with study participants throughout the intervention. Third, as the dietitians shared a common implementation context, a focus group facilitated the collection of shared perspectives, experiences, and adaptations. This method was particularly suited to capturing local contextual influences on intervention delivery.
The ECAIL RCT has approval from the committee for protection of persons engaged in research (Comité de Protection des Personnes, CPP, 24/07/2014), the national advisory committee on information processing in health research (Comité consultatif sur le traitement de l’information en matière de recherche, CCTIRS, 04/09/2014), the national data protection authority (Commission nationale de l’informatique et des libertés, CNIL, 15/06/2016). The protocol for the qualitative component was approved by the CPP the 28/06/2021. Written and signed consent were obtained from participants.
Analysis
Quantitative analysis
In addition to the eligibility rate, we compared the following implementation-related indicators between the prepandemic and post-resumption periods: Two-sided χ2 tests were used for categorical variables.
- among eligible women: participation rate, distribution of social vulnerability indicators, and mode of delivery of study information (in person or by telephone);
- among nonparticipating women: distribution of the main reasons for not participating;
- among participating women: rates of both skipped and failed follow-up visits;
- among ineligible women: proportion presenting at least one indicator of social vulnerability, along with the distribution of their social vulnerabilities and exclusion criteria.
All analyses were conducted using RStudio (2022) (RStudio: Integrated Development Environment for R. RStudio, PBC, Boston, MA).
Qualitative analysis
DP manually transcribed the focus group verbatim and imported it into NVivo software. A thematic content analysis (28) was then conducted to identify key themes related to implementation context, disruptions, adaptations, and perceived mechanisms influencing reach and engagement. Relevant quotations were assigned to corresponding themes and subthemes that reflected dietitians’ shared experiences of trial implementation during and after the pandemic.
Results
Results are presented across three RE-AIM–relevant dimensions in disrupted contextual conditions, namely Reach, Adoption, and Implementation.
Descriptive findings from the quantitative component
Eligibility for the ECAIL trial
In all, 5,744 pregnant women completed the eligibility questionnaire between March 2017 and April 2023 at the Lille University Hospital maternity ward; 1,804 were deemed eligible for the ECAIL trial. Among the women screened, 29.7% (n=955) were eligible in the prepandemic period and 33.6% (n=849) post-resumption (P=0.002). The eligibility rate remained consistently higher throughout the post-resumption observation period (P1–P3) (Fig 2).
Overall, no significant differences were observed in the distribution of social vulnerability indicators among eligible women between the prepandemic and post-resumption periods (Table 2): 78.3% received social or medical benefits; employment was not the main source of household income for 58.7%; 24.4% experienced financial hardship; 14.7% reported social isolation; 6.0% lived in precarious housing; and 19.0% presented three or more of these social vulnerabilities. However, when examined across post-resumption subperiods, Fig 3 shows that the proportion of eligible women for whom the main source of income in the household did not derive from employment was highest during P1 (64.8%), as was the receipt of social or medical benefits (82.8%). The proportion of eligible women perceiving financial hardship was highest during P3 (29.3%). Only 50.7% of eligible women received information on the study in person from the ECAIL dietitians, rather than by telephone, but this rate was higher post-resumption (57.0% compared with 45.1% before the pandemic, Table 2). Fig 2 shows that this rate was highest during P1 (59.6%) and declined progressively to 51.7% in P3.
Participation in the ECAIL trial
Overall, 24.6% of eligible women consented to participate and were included in the trial, with no difference in participation rates between prepandemic and post-resumption periods. However, participation rose slightly during periods P1 (26.9%) and P2 (28.7%), before declining in period P3 (20.1%), falling below the prepandemic level observed in P0 (23.4%) (Fig 2). The distribution of social vulnerability and implementation-related indicators differed between participating and nonparticipating women (Table 3). Across both periods, women who agreed to participate more frequently reported perceived financial hardship and were more often informed about the study in person compared with those who declined.
Nonparticipation in the ECAIL trial, despite eligibility
There was no major difference in the overall pattern of nonparticipation between the prepandemic and post-resumption periods: a majority of eligible women either remained unreachable or declined participation without providing a reason, while 29% gave at least one reason for nonparticipation (Fig 4). Screening failures primarily occurred when pregnancies were too advanced or births took place before the scheduled baseline visit, with the latter more frequent post-resumption, reflecting the suspension of the inclusion process during the first lockdown (Fig 5). Among women who provided reasons for nonparticipation, time and availability constraints were reported more frequently post-resumption, whereas partner or relative refusal and having older children were less common (Fig 6).
Ineligibility for the ECAIL trial despite social disadvantage
Among ineligible women, 19.1% (n=746) were identified as experiencing at least one social vulnerability (according to the eligibility questionnaire) but also met at least one exclusion criterion. Their profile of social vulnerability was overall more severe than that of eligible women, particularly regarding unemployment, perceived financial hardship, precarious housing, and accumulation of ≥3 of these social vulnerabilities criteria (Table 4). Furthermore, among socially disadvantaged but ineligible women, the proportion experiencing social isolation during their pregnancy increased from 15.0% prepandemic to 21.5% post-resumption, while the proportion reporting precarious housing rose from 11.7% to 19.8%. Likewise, housing instability worsened across periods among socially vulnerable women meeting exclusion criteria: the proportion who had moved several times in the previous 12 months increased from 16.6% prepandemic to 25.3% post-resumption, and the proportion living in emergency accommodation, portable dwellings, or who were experiencing homelessness increased from 7.1% to 15.4%.
Follow-up
From March 2017 to April 2023, only 2% (n=46) of the 2,316 expected follow-up visits were skipped, with no difference between prepandemic and post-resumption periods (Table 2). The rate of failed visits (the dietitian made the trip but the participant was not present) was, however, lower after the study resumed (1.7%) than before the COVID-19 outbreak (4.9%).
Findings from the qualitative component
The focus group, which lasted 81 minutes, explored how COVID-19 affected home visit delivery, strategies to maintain relationships with participating families, the pivotal moment of the resumption of home visits, and the acceptability of the adapted health protocol for both dietitians and families. Table 5 presents the key themes and illustrative quotations. During the first lockdown, dietitians expressed uncertainty and concern about whether, when, and how the study would resume. Despite obstacles, they were resolute in implementing the study through home visits, arguing that the remote solutions developed during the lockdown did not fit the trial’s specific features. Their point of view was important in designing the subsequent adaptations, as they took part in discussions surrounding implementation under new constraints, and they anticipated resumption by maintaining contact with participants through telephone calls and newsletters. These adaptations appeared to have strengthened engagement and commitment when home visits became possible again. Both dietitians and participants (as reported by dietitians) expressed gladness at the resumption of the trial. The ECAIL study was prioritized by Lille University Hospital over other trials because of the social vulnerability of its participants. Dietitians reported that mothers described these visits as helping to alleviate social isolation, which had intensified during successive lockdowns. Dietitians did not perceive mask-wearing during hospital screenings or home visits as a barrier to women’s participation or to building rapport during follow-up visits, given the widespread use of masks at the time. Yet they allowed themselves to relax mask use during home visits, with mothers’ authorization, in cases where it hindered interactions with the child. Finally, the pre-visit COVID-19 risk assessment questionnaire was perceived as an effective implementation adaptation, helping to reduce failed visits and save time.
Discussion
This interdisciplinary study of an ongoing public health intervention among socially disadvantaged families provides implementation-relevant insights into the effects of the COVID-19 pandemic and the subsequent cost-of-living crisis. Interpreted through a RE-AIM lens (19, 20), our findings indicate that these contextual shocks expanded the pool of eligible individuals, enhancing the intervention’s relevance (Reach), without compromising provider Adoption or Implementation, and possibly reinforcing engagement during key phases of delivery. Quantitative and qualitative findings converged, showing shifts in eligibility and participation profiles alongside sustained involvement of both implementers and participants, resulting in a stable rhythm of home visits after resumption, with some parents eager to re-establish social contact. These health and economic shocks also affected socially disadvantaged families beyond those eligible for the ECAIL trial, exacerbating existing social and material vulnerabilities. Taken together, these findings point to robust implementation and short-term maintenance despite major contextual disruptions and inform the design of more resilient interventions.
Participation
Participation in the ECAIL trial increased slightly during the post-resumption P1 and P2 subperiods. From an Implementation perspective, it confirms the dieticians’ impression that screening interviews were unaffected by the protective measures such as masks. From an Adoption perspective, this was likely associated with a higher frequency of face-to-face delivery of study information at the maternity ward, rather than telephone contact. Direct interactions between dietitians and women (and their partners, when present) appeared more effective in initiating engagement than delayed, impersonal phone calls, although this depended on HCPs contacting dietitians during prenatal appointments. The prioritization of the ECAIL trial likely created favorable conditions for its implementation, reflecting an equity-oriented approach. In this context, regular meetings between the ECAIL team and HCPs likely supported sustained and synergistic collaboration despite pandemic-related pressures on hospital services. Together, quantitative and qualitative findings converged to suggest strengthened coordination between dietitians and HCPs during the early post-resumption period (P1). However, HCP engagement appeared to decline slightly during period P3, in parallel with the decrease in participation. This may reflect increased workload following the resumption of other clinical trials, compounded by persistent disruptions and time constraints affecting hospital services. The slight decrease in participation during P3 may also reflect the cumulative burden of successive crises, which likely reduced women’s availability and willingness to participate, as suggested by the more frequent reporting of time constraints and unavailability among those who declined participation post-resumption. These findings highlight the prolonged and evolving impact of crises, underscoring the importance of considering temporal dynamics in their effects.
Follow-up
Across both qualitative and quantitative components, there was clear evidence that dietitians and families were eagerly awaiting the resumption of visits. During the first lockdown, dietitians maintained regular contact with participants. This continuity of contact emerged as a key implementation mechanism for sustaining family engagement, as reflected in the very low rate of skipped home visits. The implementation of COVID-19 -specific health protocols facilitated preliminary exchanges, reduced potential apprehension among participants, and contributed to fewer missed appointments.
These observations have significant methodological implications and highlight the value of ongoing relational work between follow-up visits. This requires additional human resources and research time, particularly when working with socially disadvantaged populations, who are known to be “hard-to-survey” (21, 22). However, this investment appears cost-effective, as it saves time in the long term, improves adherence to the study protocol, fosters participant commitment, and enhances data quality by limiting missed visits. More broadly, our findings reinforce the relevance of home-based delivery for reaching and engaging populations facing social adversity, who often have lower utilization of health care and community services and experience greater social isolation (43, 44), while facilitating one-on-one interactions that foster trust between providers and mothers and enable more personalized and context-sensitive interventions (18).
Perspectives
This study examined how the distribution of social vulnerability criteria differed between eligible and ineligible women, as well as between participants and nonparticipants, an aspect that remains rarely explored in implementation research (44). It also illustrates how such data can be collected and analyzed to evaluate intervention reach (45). These findings provide important insights for interpreting the external validity of the trial and the potential generalizability of future effectiveness results. Additionally, qualitative interviews are currently being conducted with participating mothers to explore their motivations, contextual constraints, and perceptions of participation. These complementary data will contribute to a more comprehensive process evaluation of this complex public health intervention (46–49).
Limitations and strengths
One limitation of this study is the timing of the group interview, conducted two years after the last lockdown, which may have introduced a recall bias. Nonetheless, the vividness of the dietitians’ recollections underscores the lasting impact of this period and the relevance of capturing these experiences retrospectively. While effectiveness outcomes are not examined here, this focus is consistent with the RE-AIM framework’s emphasis on disentangling reach, adoption, and implementation processes as necessary precursors to effectiveness and sustainability (19). A major strength lies in the triangulation of quantitative and qualitative methods (27, 44, 47), which enabled a comprehensive understanding of how successive crises shaped both the characteristics of the target population and the implementation processes of the intervention. Importantly, the inclusion of dietitians’ perspectives represents a further strength, as the views of frontline staff, particularly those directly involved in participant interaction and data collection, are still relatively rarely captured in implementation research. The study’s focus on pregnant women experiencing social vulnerabilities, a heterogeneous population that remains largely underrepresented in epidemiological research, provides new knowledge about the specific barriers to intervention delivery and engagement in a context of worsening poverty. The adjustments made after the onset of the COVID-19 pandemic illustrate the flexibility of this complex interventional research in responding to unforeseen events and adapting implementation to enable study continuation (46, 48). They also suggest that home visits and one-to-one interactions may strengthen participation and commitment, even when face-to-face contact is constrained.
Conclusion
The social impact of both the pandemic and the cost-of-living crisis, often described as the “second health emergency” (5), is reflected in the ECAIL trial by a higher eligibility rate among socially disadvantaged families, while the participation rate remained stable. These findings provide important insights into how crises affect the ability of vulnerable families to engage in programs designed to mitigate social disadvantage. In the case of ECAIL, the health crisis did not undermine stakeholder or participant commitment to this co-created intervention. On the contrary, the collaborative foundations of the project appear to have supported sustained engagement by HCPs despite increased workload and organizational strain within hospitals. HCPs reported remaining committed to seeing the project through to completion, recognizing its social and public health importance. Moreover, home visits and telephone calls between follow-ups were perceived as effective implementation strategies, not only for reaching families and supporting adherence, but also for mitigating social isolation among participants. Overall, these findings suggest that interventions co-designed with stakeholders and target populations, and supported by appropriate implementation strategies, can remain resilient even in the face of major external disruptions, an insight that is particularly relevant in a context of rising poverty and ongoing geopolitical and economic instability worldwide.
Data Availability
All data supporting the findings of this study are included in the present article or the supplemental material.
Abbreviations
- ECAIL
- prEgnanCy and eArly Childhood nutrItion triaL;
- HCP
- healthcare provider;
- Insee
- National Institute of Statistics and Economic Studies;
- Inserm
- National institute for health and medical research;
- RE-AIM
- Reach, Effectiveness, Adoption, Implementation and Maintenance.
Acknowledgments
The authors thank all stakeholders involved in the ECAIL study since 2012 for its co-design and since 2017 for its implementation, i.e., members from the Malin program nonprofit association involved in the co-creation of the ECAIL trial and/or the training of ECAIL dietitians, namely: Solène Bonhoure, Marie-Cécile Bret, Louise Jolly, Nelly Perez, Marie Polycarpe, Julie Simon, and Raphaëlle Sorba; Pr Dominique Turck (member of the French Society of Pediatrics and PI at the Lille University Hospital until 2023) and Dr Catherine Salinier (member of the French Association for Ambulatory Pediatrics) for their valuable engagement in the collaborative development, training and support for this interventional research; all dietitians for the implementation of the trial at the two study sites since 2017, namely: Yasmine Améziane, Solène Brun, Marjorie Daman, Marine Charlier, Emma Creps, Pauline Ditilyeu, Virginie Fourcaut, Noémie Jérôme, Sarah Mille, Amélie Siemiatkowski and Tiphaine Spas; all health care providers involved in the screening, monitoring or training at the two hospital maternity wards, especially Dr Sandy Hanssens, Karine Rogelet, Samantha Meyer, Hugues Bachelart, Nathan Storme, Florence Flamein, Aurore Dehon and Dr Pauline Devouge (PI at the Valenciennes Hospital); Céline Sardano-Garci, Faryal Harrar, and Uriel Makela at Inserm for their contribution to the data collection and/or the production of the participant newsletter; Coline Dumoulin, Françoise Fromageau, Thierry Couvert Leroy, and Marc Vannesson at the French Red Cross; and, last but not least, all participating families for their invaluable contribution to this research. The authors also thank Jo Ann Cahn for her help in preparing the manuscript.
Funding
The ECAIL project has received funding from the Agence nationale de la recherche (ANR-12-DSSA-0001, SOFI and ANR-19-CE36-0006, NutPrev); the Fonds Français pour l’Alimentation et la Santé (FFAS-12-A-010); Blédina; the Institut de recherche en santé publique (IReSP): as part of the call for projects launched by IReSP in 2015 “Programme Prévention Primaire 2015”, this research was supported by the Direction Générale de la Santé (DGS), the Caisse Nationale de l’Assurance Maladie des Travailleurs Salariés (CNAMTS), the Mission interministérielle de la lutte contre les drogues et les conduites addictives (MILDECA) and the Observatoire national des Jeux (ODJ) (IReSP-15-Prévention-07); additionally, as part of the 2022 call for research projects on health-promoting services, interventions and policies (SIP), this research was supported the CNAM, the DGS, Inserm and Santé Publique France (AAP-2022-SIP-311921); the Guy Demarle Enfance & Bien Manger Foundation Price, under the umbrella of the Fondation de France in 2018; the Joint Programming Initiative ‘A Healthy Diet for a Healthy Life’ PREPHOBES (JPI-HDHL-INTIMIC 2020); the Projet Fédératif Hospitalo Universitaire (FHU) 1000 days of the Lille University Hospital; the Fondation Roquette pour la Santé, under the umbrella of the Fondation de France ; the Agence Régionale de Santé des Hauts-de-France; the Fonds AXA pour le Progès Humain (Health Philanthropy Program of Mutuelles d’Assurance AXA); and the Délégation interministérielle à la prévention et à la lutte contre la pauvreté (DILP, Interministerial Delegation for the Prevention and Fight against Poverty) set up as part of the Solidarity Pact national policy. The funding bodies did not play any role in the design of the study; collection, analysis, and interpretation of data; nor in writing the manuscript.