How does a social norms-based intervention affect behaviour change? Interim findings from a cluster randomised controlled trial in Odisha, India.
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ABSTRACT: Background
Behaviour change interventions targeting social norms are burgeoning, but researchers have little guidance on what they look like, and which components affect behaviour change. The Reduction in Anaemia through Normative Innovations (RANI) project designed an intervention to increase iron folic acid (IFA) consumption in Odisha, India.Objective
This paper examines the effect of the intervention at midline to understand which components of the RANI intervention affect uptake.Methods
Using a cluster randomised controlled design, we collected baseline data and midline data 6 months later from women of reproductive age in the control and treatment arms (n=3800) in Angul, Odisha, India. Using nested models, we analysed data from three different intervention components, monthly community-based testing for anaemia, participatory group education sessions, and videos, to determine the extent to which exposure to each of these components accounted for the overall intervention effect on haemoglobin and self-reported IFA use.Results
Overall, residing in a treatment as opposed to control village had little effect on midline haemoglobin, but increased the odds of taking supplements by 17 times. Exposure to each of the intervention components had a dose-response relationship with self-reported IFA use. These components, separately and together, accounted for most of the overall effect of treatment assignment on IFA use.Conclusions
All intervention components increased iron supplement use to differing degrees of magnitude. It appears that a social norms-based approach can result in improving IFA uptake, though improvements in haemoglobin counts were not yet discernible.
SUBMITTER: Sedlander E
PROVIDER: S-EPMC9272109 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundIn India, 50% of women of reproductive age, compared with 23% of men, have iron deficiency anemia. Extant research focuses on biological, not social, determinants of this disparity.ObjectivesThe aim of this study was to examine how gender norms may affect anemia prevalence among women in rural India.MethodsWe conducted 16 focus group discussions (N = 124) with women of reproductive age, husbands, and mothers-in-law and 25 key informant interviews in four villages in Odisha, India.ResultsWe identified the following themes that help explain how inequitable gender norms exacerbate anemia among women from different castes and tribes: Due to a double burden of work outside the home and completing the majority of unpaid work in the home, women lack time to visit health centers to get tested for anemia and to obtain iron supplements. Women are expected to prioritize the health of their family over their own, thus affecting their access to health care. Women's autonomy to leave the house to seek health care is limited. Men are the primary breadwinners for the family, but often spend their money on alcohol, rather than on iron-rich food for the household. Intra-household food allocation favors men, in-laws, and children, thus women serve their family first, often being left with little food.ConclusionAnemia reduction interventions need to include examination of the whole social context to successfully increase iron supplement use and iron-rich food intake. Understanding how gender norms contribute to anemia could change the narrative from a biomedical to a social justice issue.
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Project description:BackgroundEffective and scalable behaviour change interventions to increase use of existing toilets in low income settings are under debate. We tested the effect of a novel intervention, the '5 Star Toilet' campaign, on toilet use among households owning a toilet in a rural setting in the Indian state of Gujarat.MethodsThe intervention included innovative and digitally enabled campaign components delivered over 2 days, promoting the upgrading of existing toilets to achieve use by all household members. The intervention was tested in a cluster randomised trial in 94 villages (47 intervention and 47 control). The primary outcome was the proportion of households with use of toilets by all household members, measured through self- or proxy-reported toilet use. We applied a separate questionnaire tool that masked open defecation questions as a physical activity study, and excluded households surveyed at baseline from the post-intervention survey. We calculated prevalence differences using linear regression with generalised estimating equations.ResultsThe primary study outcome was assessed in 2483 households (1275 intervention and 1208 control). Exposure to the intervention was low. Post-intervention, toilet use was 83.8% in the control and 90.0% in the intervention arm (unadjusted difference + 6.3%, 95%CI 1.1, 11.4, adjusted difference + 5.0%, 95%CI -0.1, 10.1. The physical activity questionnaire was done in 4736 individuals (2483 intervention and 2253 control), and found no evidence for an effect (toilet use 80.7% vs 82.2%, difference + 1.7%, 95%CI -3.2, 6.7). In the intervention arm, toilet use measured with the main questionnaire was higher in those exposed to the campaign compared to the unexposed (+ 7.0%, 95%CI 2.2%, 11.7%), while there was no difference when measured with the physical activity questionnaire (+ 0.9%, 95%CI -3.7%, 5.5%). Process evaluation suggested that insufficient campaign intensity may have contributed to the low impact of the intervention.ConclusionThe study highlights the challenge in achieving high intervention intensity in settings where the proportion of the total population that are potential beneficiaries is small. Responder bias may be minimised by masking open defecation questions as a physical activity study. Over-reporting of toilet use may be further reduced by avoiding repeated surveys in the same households.Trial registrationThe trial was registered on the RIDIE registry ( RIDIE-STUDY-ID-5b8568ac80c30 , 27-8-2018) and retrospectively on clinicaltrials.gov ( NCT04526171 , 30-8-2020).
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Project description:Behaviour change communication (BCC) can improve infant and young child nutrition (IYCN) knowledge, practices, and health outcomes. However, few studies have examined whether the improved knowledge persists after BCC activities end. This paper assesses the effect of nutrition sensitive social protection interventions on IYCN knowledge in rural Bangladesh, both during and after intervention activities. We use data from two, 2-year, cluster randomised control trials that included nutrition BCC in some treatment arms. These data were collected at intervention baseline, midline, and endline, and 6-10 months after the intervention ended. We analyse data on IYCN knowledge from the same 2,341 women over these 4 survey rounds. We construct a number correct score on 18 IYCN knowledge questions and assess whether the impact of the BCC changes over time for the different treatment groups. Effects are estimated using ordinary least squares accounting for the clustered design of the study. There are 3 main findings: First, the BCC improves IYCN knowledge substantially in the 1st year of the intervention; participants correctly answer 3.0-3.2 more questions (36% more) compared to the non-BCC groups. Second, the increase in knowledge between the 1st and 2nd year was smaller, an additional 0.7-0.9 correct answers. Third, knowledge persists; there are no significant decreases in IYCN knowledge 6-10 months after nutrition BCC activities ended.
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Project description:BACKGROUND:A cluster-Randomised Controlled Trial evaluation of the impact of the Community Health Clubs (CHCs) in the Community Based Environmental Health Promotion Programme in Rwanda in 2015 appeared to find little uptake of 7 hygiene indicators 1 year after the end of the intervention, and low impact on prevention of diarrhoea and stunting. METHODS:Monitoring data was revisited through detailed community records with all the expected inputs, outputs and external determinants analysed for fidelity to the research protocol. Five household inventory observations were taken over a 40-month period including 2 years after the end of the cRCT in a random selection of the 50 intervention CHCs and data compared to that of the trial. Focus Group Discussion with all Environmental Health Officers of the Ministry of Health provided context to understand the long-term community dynamics of hygiene behaviour change. RESULTS:It was found that the intervention had been jeopardised by external determinants with only 54% fidelity to protocol. By the end of the designated intervention period in June 2014, the treatment had reached only 58% of households with 41% average attendance at training sessions by the 4056 registered members and 51% mean completion rate of 20+ sessions. Therefore only 10% of 50 CHCs provided the full so-called 'Classic' training as per-protocol. However, sustainability of the CHCs was high, with all 50 being active 2 years after the end of the cRCT and over 80% uptake of recommended practices of the same 7 key indicators as the trial was achieved by 2017. CONCLUSIONS:The cRCT conclusion that the case study of Rusizi District does not encourage the use of the CHC model for scaling up, raises concerns over the possible misrepresentation of the potential of the holistic CHC model to achieve health impact in a more realistic time frame. It also questions the appropriateness of apparently rigorous quantitative research, such as the cluster-Randomised Controlled Trial as conducted in Rusizi District, to adequately assess community dynamics in complex interventions.
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Project description:BackgroundThere is an abundance of guidance for the interim monitoring of individually randomised trials. While methodological literature exists on how to extend these methods to cluster randomised trials, there is little guidance on practical implementation. Cluster trials have many features which make their monitoring needs different. We outline the methodological and practical challenges of interim monitoring of cluster trials; and apply these considerations to a case study.Case studyThe E-MOTIVE study is an 80-cluster randomised trial of a bundle of interventions to treat postpartum haemorrhage. The proposed data monitoring plan includes (1) monitor sample size assumptions, (2) monitor for evidence of selection bias, and (3) an interim assessment of the primary outcome, as well as monitoring data completeness. The timing of the sample size monitoring is chosen with both consideration of statistical precision and to allow time to recruit more clusters. Monitoring for selection bias involves comparing individual-level characteristics and numbers recruited between study arms to identify any post-randomisation participant identification bias. An interim analysis of outcomes presented with 99.9% confidence intervals using the Haybittle-Peto approach should mitigate any concern regarding the inflation of type-I error. The pragmatic nature of the trial means monitoring for adherence is not relevant, as it is built into a process evaluation.ConclusionsThe interim analyses of cluster trials have a number of important differences to monitoring individually randomised trials. In cluster trials, there will often be a greater need to monitor nuisance parameters, yet there will often be considerable uncertainty in their estimation. This means the utility of sample size re-estimation can be questionable particularly when there are practical or funding difficulties associated with making any changes to planned sample sizes. Perhaps most importantly interim monitoring has the potential to identify selection bias, particularly in trials with post-randomisation identification or recruitment. Finally, the pragmatic nature of cluster trials might mean that the utility of methods to allow for interim monitoring of outcomes based on statistical testing, or monitoring for adherence to study interventions, are less relevant. Our intention is to facilitate the planning of future cluster randomised trials and to promote discussion and debate to improve monitoring of these studies.
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Project description:Self-regulation processes assume a major role in health behaviour theory and are postulated as important mechanisms of action in behavioural interventions to improve health prevention and management. The need to better understand mechanisms of behaviour change interventions for cardiovascular diseases (CVD) called for conducting a meta-review of meta-analyses for interventions targeting self-regulation processes. The protocol, preregistered on Open Science Framework (OSF), found 15 eligible meta-analyses, published between 2006 and August 2019, which quantitatively assessed the role of self-regulatory mechanisms and behaviour change techniques (BCTs). Quality of the meta-analyses varied widely according to AMSTAR-2 criteria. Several BCTs, assumed to engage self-regulatory mechanisms, were unevenly represented in CVD meta-analytic reviews. Self-monitoring, the most frequently studied self-regulatory BCT, seemed to improve health behaviour change and health outcomes but these results merit cautious interpretation. Findings for other self-regulatory BCTs were less promising. No studies in the CVD domain directly tested engagement of self-regulation processes. A general challenge for this area stems from reliance on post-hoc tests of the effects of BCTs in multiple-component interventions. Recent advances in BCT taxonomies and the experimental medicine approach to engaging self-regulation mechanisms, however, provide opportunities to improve CVD prevention and management behavioural interventions.
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Project description:Difficulty in characterizing the relationship between climatic variability and climate change vulnerability arises when we consider the multiple scales at which this variation occurs, be it temporal (from minute to annual) or spatial (from centimetres to kilometres). We studied populations of a single widely distributed butterfly species, Chlosyne lacinia, to examine the physiological, morphological, thermoregulatory and biophysical underpinnings of adaptation to tropical and temperate climates. Microclimatic and morphological data along with a biophysical model documented the importance of solar radiation in predicting butterfly body temperature. We also integrated the biophysics with a physiologically based insect fitness model to quantify the influence of solar radiation, morphology and behaviour on warming impact projections. While warming is projected to have some detrimental impacts on tropical ectotherms, fitness impacts in this study are not as negative as models that assume body and air temperature equivalence would suggest. We additionally show that behavioural thermoregulation can diminish direct warming impacts, though indirect thermoregulatory consequences could further complicate predictions. With these results, at multiple spatial and temporal scales, we show the importance of biophysics and behaviour for studying biodiversity consequences of global climate change, and stress that tropical climate change impacts are likely to be context-dependent.
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Project description:BackgroundWe evaluated the effectiveness and cost-effectiveness of a loyalty scheme based intervention involving rewards for increasing physical activity in public sector employees.MethodsA cluster randomised wait-list controlled trial in public sector organisations in Northern Ireland. We randomly assigned clusters (1:1) using a computer generated random sequence. Researchers were masked to allocation, but participants were not. Employees aged 18-65 years with no self-reported medical contraindications to physical activity were included. The Physical Activity Loyalty Scheme (PAL) intervention was based on high-street loyalty cards where participants earned points for minutes of activity that could be redeemed for rewards, complemented by evidence-based behaviour change techniques. The primary outcome was objectively measured mean steps/day at 6 months using a validated pedometer (Yamax Digi-Walker CW-701) over 7 days, assessed with intention to treat analysis. Secondary outcomes included health, mental wellbeing, quality of life, work absenteeism and presenteeism, and use of healthcare resources. Cost-effectiveness, cost-benefit and mediation analyses were conducted. Trial registered with Current Controlled Trials, number ISRCTN17975376.ResultsBetween September 2014 and October 2015, we recruited and randomly assigned 37 clusters (from nine organisations; mean clusters per organisation = four) and 853 participants to the intervention (n = 19 with 457 participants) or control group (n = 18 with 396 participants). Primary outcome data were available for 249 (54·4%) intervention and 236 (59·6%) control participants. Mean steps/day were significantly lower in the intervention vs control group (adjusted mean difference = - 336, 95% CI: -612 to - 60, p = 0·02) at 6 months. Participants redeemed only 39% (SD 43%) of their earned points. Using the Quality Adjusted Life Year outcome, the intervention was not cost effective from an NHS/PSS perspective. A net cost analysis from an employer perspective demonstrated the intervention group was associated with a mean of 2·97 h less absenteeism over a 4 week period (p = 0·62), which could result in net savings ranging from £66 to £735 depending on the wage rate employed. At 4-weeks post-baseline there were significant increases in identified regulation, integrated regulation, intrinsic motivation, social norms and intentions in intervention compared to control participants.ConclusionsOur mixed results pose challenges that are too infrequently exposed in public heath intervention trials. Although the intervention successfully altered several hypothesised mediating constructs it did not translate into long-term behaviour change. Our incentive level may have been too low to incentivise change, despite being designed a priori by a Contingent Valuation Survey. There were also major re-structuring of several organisations which presented significant implementation challenges, and technical limitations.Trial registrationISRCTN17975376 (Registered 19/09/2014).
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