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The Philani MOVIE study: a cluster-randomized controlled trial of a mobile video entertainment-education intervention to promote exclusive breastfeeding in South Africa.

ABSTRACT: BACKGROUND:In South Africa, rates of exclusive breastfeeding remain low and breastfeeding promotion is a national health priority. Mobile health and narrative entertainment-education are recognized strategies for health promotion. In-home counseling by community health workers (CHWs) is a proven breastfeeding promotion strategy. This protocol outlines a cluster-randomized controlled trial with a nested mixed-methods evaluation of the MObile Video Intervention for Exclusive breastfeeding (MOVIE) program. The evaluation will quantify the causal effect of the MOVIE program and generate a detailed understanding of the context in which the intervention took place and the mechanisms through which it enacted change. Findings from the study will inform the anticipated scale-up of mobile video health interventions in South Africa and the wider sub-Saharan region. METHODS:We will conduct a stratified cluster-randomized controlled trial in urban communities of the Western Cape, to measure the effect of the MOVIE intervention on exclusive breastfeeding and other infant feeding practices. Eighty-four mentor-mothers (CHWs employed by the Philani Maternal Child Health and Nutrition Trust) will be randomized 1:1 into intervention and control arms, stratified by neighborhood type. Mentor-mothers in the control arm will provide standard of care (SoC) perinatal in-home counseling. Mentor-mothers in the intervention arm will provide SoC plus the MOVIE intervention. At least 1008 pregnant participants will be enrolled in the study and mother-child pairs will be followed until 5?months post-delivery. The primary outcomes of the study are exclusive breastfeeding at 1 and 5?months of age. Secondary outcomes are other infant feeding practices and maternal knowledge. In order to capture human-centered underpinnings of the intervention, we will conduct interviews with stakeholders engaged in the intervention design. To contextualize quantitative findings and understand the mechanisms through which the intervention enacted change, end-line focus groups with mentor-mothers will be conducted. DISCUSSION:This trial will be among the first to explore a video-based, entertainment-education intervention delivered by CHWs and created using a community-based, human-centered design approach. As such, it could inform health policy, with regards to both the routine adoption of this intervention and, more broadly, the development of other entertainment-education interventions for health promotion in under-resourced settings. TRIAL REGISTRATION:The study and its outcomes were registered at clinicaltrials.gov ( #NCT03688217 ) on September 27th, 2018.

SUBMITTER: Adam M

PROVIDER: S-EPMC6444854 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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The Philani MOVIE study: a cluster-randomized controlled trial of a mobile video entertainment-education intervention to promote exclusive breastfeeding in South Africa.

Adam Maya M Tomlinson Mark M Le Roux Ingrid I LeFevre Amnesty E AE McMahon Shannon A SA Johnston Jamie J Kirton Angela A Mbewu Nokwanele N Strydom Stacy-Leigh SL Prober Charles C Bärnighausen Till T

BMC health services research 20190402 1

<h4>Background</h4>In South Africa, rates of exclusive breastfeeding remain low and breastfeeding promotion is a national health priority. Mobile health and narrative entertainment-education are recognized strategies for health promotion. In-home counseling by community health workers (CHWs) is a proven breastfeeding promotion strategy. This protocol outlines a cluster-randomized controlled trial with a nested mixed-methods evaluation of the MObile Video Intervention for Exclusive breastfeeding ...[more]

PMID: 30940132

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Project description:BackgroundIn South Africa, breastfeeding promotion is a national health priority. Regular perinatal home visits by community health workers (CHWs) have helped promote exclusive breastfeeding (EBF) in underresourced settings. Innovative, digital approaches including mobile video content have also shown promise, especially as access to mobile technology increases among CHWs. We measured the effects of an animated, mobile video series, the Philani MObile Video Intervention for Exclusive breastfeeding (MOVIE), delivered by a cadre of CHWs ("mentor mothers").Methods and findingsWe conducted a stratified, cluster-randomized controlled trial from November 2018 to March 2020 in Khayelitsha, South Africa. The trial was conducted in collaboration with the Philani Maternal Child Health and Nutrition Trust, a nongovernmental community health organization. We quantified the effect of the MOVIE intervention on EBF at 1 and 5 months (primary outcomes), and on other infant feeding practices and maternal knowledge (secondary outcomes). We randomized 1,502 pregnant women in 84 clusters 1:1 to 2 study arms. Participants' median age was 26 years, 36.9% had completed secondary school, and 18.3% were employed. Mentor mothers in the video intervention arm provided standard-of-care counseling plus the MOVIE intervention; mentor mothers in the control arm provided standard of care only. Within the causal impact evaluation, we nested a mixed-methods performance evaluation measuring mentor mothers' time use and eliciting their subjective experiences through in-depth interviews. At both points of follow-up, we observed no statistically significant differences between the video intervention and the control arm with regard to EBF rates and other infant feeding practices [EBF in the last 24 hours at 1 month: RR 0.93 (95% CI 0.86 to 1.01, P = 0.091); EBF in the last 24 hours at 5 months: RR 0.90 (95% CI 0.77 to 1.04, P = 0.152)]. We observed a small, but significant improvement in maternal knowledge at the 1-month follow-up, but not at the 5-month follow-up. The interpretation of the results from this causal impact evaluation changes when we consider the results of the nested mixed-methods performance evaluation. The mean time spent per home visit was similar across study arms, but the intervention group spent approximately 40% of their visit time viewing videos. The absence of difference in effects on primary and secondary endpoints implies that, for the same time investment, the video intervention was as effective as face-to-face counseling with a mentor mother. The videos were also highly valued by mentor mothers and participants. Study limitations include a high loss to follow-up at 5 months after premature termination of the trial due to the COVID-19 pandemic and changes in mentor mother service demarcations.ConclusionsThis trial measured the effect of a video-based, mobile health (mHealth) intervention, delivered by CHWs during home visits in an underresourced setting. The videos replaced about two-fifths of CHWs' direct engagement time with participants in the intervention arm. The similar outcomes in the 2 study arms thus suggest that the videos were as effective as face-to-face counselling, when CHWs used them to replace a portion of that counselling. Where CHWs are scarce, mHealth video interventions could be a feasible and practical solution, supporting the delivery and scaling of community health promotion services.Trial registrationThe study and its outcomes were registered at clinicaltrials.gov (#NCT03688217) on September 27, 2018.

Project description:In this multi-country cluster-randomized behavioural intervention trial promoting exclusive breastfeeding (EBF) in Africa, we compared growth of infants up to 6 months of age living in communities where peer counsellors promoted EBF with growth in those infants living in control communities.A total of 82 clusters in Burkina Faso, Uganda and South Africa were randomised to either the intervention or the control arm. Feeding data and anthropometric measurements were collected at visits scheduled 3, 6, 12 and 24 weeks post-partum. We calculated weight-for-length (WLZ), length-for-age (LAZ) and weight-for-age (WAZ) z-scores. Country specific adjusted Least Squares Means with 95% confidence intervals (CI) based on a longitudinal analysis are reported. Prevalence ratios (PR) for the association between peer counselling for EBF and wasting (WLZ?<?-2), stunting (LAZ?<?-2) and underweight (WAZ?<?-2) were calculated at each data collection point.The study included a total of 2,579 children. Adjusting for socio-economic status, the mean WLZ at 24 weeks were in Burkina Faso -0.20 (95% CI -0.39 to -0.01) and in Uganda -0.23 (95% CI -0.43 to -0.03) lower in the intervention than in the control arm. In South Africa the mean WLZ at 24 weeks was 0.23 (95% CI 0.03 to 0.43) greater in the intervention than in the control arm. Differences in LAZ between the study arms were small and not statistically significant. In Uganda, infants in the intervention arm were more likely to be wasted compared to those in the control arm at 24 weeks (PR 2.36; 95% CI 1.11 to 5.00). Differences in wasting in South Africa and Burkina Faso and stunting and underweight in all three countries were small and not significantly different.There were small differences in mean anthropometric indicators between the intervention and control arms in the study, but in Uganda and Burkina Faso, a tendency to slightly lower ponderal growth (weight-for-length z-scores) was found in the intervention arms.ClinicalTrials.gov: NCT00397150.

Project description:BACKGROUND:Infant mortality rates are still high in Ethiopia. Breastfeeding is regarded as the simplest and least expensive strategy for reduction of infant mortality rates. Community-based educational and support interventions provided prenatally and postnatally are effective in increasing breastfeeding rates. However, such interventions are not widely implemented in Ethiopia. This study aims to assess the effect of breastfeeding education and support on timely initiation and duration of exclusive breastfeeding. METHODS:A cluster-randomized controlled trial at the community level will be conducted to compare the effect of breastfeeding education and support versus routine care. The intervention will be provided by Women Development Army leaders who are already in the country's health system using a 40-h WHO breastfeeding counseling course, "Infant and Young Child Feeding Counseling: an integrated course" and the "Training of Trainers Manual for Counseling on Maternal, Infant and Young Child Nutrition" in the local language. Culturally appropriate operational packages of information will be developed for them. Using preset criteria at least 432 pregnant women in their third trimester will be recruited from 36 zones. Visits in the intervention arm include two prenatal visits and 8 postnatal visits. Supervisory visits will be conducted monthly to each intervention zone. Data will be entered into Epi-data version 3.1 and analyzed using STATA version 13.0. All analysis will be done by intention to treat analysis. We will fit mixed-effects linear regression models for the continuous outcomes and mixed-effects linear probability models for the binary outcomes with study zone as random intercept to estimate study arm difference (intervention vs. routine education) adjusted for baseline value of the outcome and additional relevant covariates. The protocol was developed in collaboration with the Jimma Zone and Mana district Health office. Ethical clearance was obtained from the Institutional Review Board of University of Oslo and Jimma University. This study is partly funded by NORAD's NORHED programme. DISCUSSION:We expect that the trial will generate findings that can inform breastfeeding policies and practices in Ethiopia. TRIAL REGISTRATION:ClinicalTrials.gov NCT 03030651 January 25, 2017 version 3 dated 16 July 2018.

Project description:IntroductionIndia's national AIDS Control Organization implemented World Health Organization's option B+ HIV prevention of mother-to-child transmission (PMTCT) guidelines in 2013. However, scalable strategies to improve uptake of new PMTCT guidelines to reduce new infection rates are needed. This study assessed impact of Mobile Health-Facilitated Behavioral Intervention on the uptake of PMTCT services.MethodsA cluster-randomized trial of a mobile health (mHealth)-supported behavioural training intervention targeting outreach workers (ORWs) was conducted in four districts of Maharashtra, India. Clusters (one Integrated Counselling and Testing Center (ICTC, n = 119), all affiliated ORWs (n = 116) and their assigned HIV-positive pregnant/postpartum clients (n = 1191)) were randomized to standard-of-care (SOC) ORW training vs. the COMmunity home Based INDia (COMBIND) intervention - specialized behavioural training plus a tablet-based mHealth application to support ORW-patient communication and patient engagement in HIV care. Impact on uptake of maternal antiretroviral therapy at delivery, exclusive breastfeeding at six months, infant nevirapine prophylaxis, and early infant diagnosis at six months was assessed using multi-level random-effects logistic regression models.ResultsOf 1191 HIV-positive pregnant/postpartum women, 884 were eligible for primary outcome assessment; 487 were randomized to COMBIND. Multivariable analyses identified no statistically significant differences in any primary outcome by study arm. COMBIND was associated with higher uptake of exclusive breastfeeding at two months (adjusted Odds Ratio (aOR), 2.10; 95% CI 1.06 to 4.15) and early infant diagnosis at six weeks (aOR, 2.19; 95% CI 1.05 to 3.98) than SOC.ConclusionsThe COMBIND intervention was easily integrated into India's existing PMTCT programme and improved early uptake of two PMTCT components that require self-motivated health-seeking behaviour, thus providing preliminary evidence to support COMBIND as a potentially scalable PMTCT strategy. Further study would identify modifications needed to optimize other PMTCT outcomes.

Project description:BACKGROUND:Exclusive breastfeeding rates in many high-income countries are considerably lower than the World Health Organization recommendations. Younger mothers are less likely than older mothers to exclusively breastfeed or to exclusively breastfeed for a long duration. This systematic review explores interventions to increase the rate of exclusive breastfeeding among young mothers in high-income countries. METHODS:A systematic search of the following databases was completed in August 2020: CINAHL, PubMed, MEDLINE, ProQuest, PsychInfo, Web of Science, Cochrane, Scopus and Embase. A manual search of the reference lists of all the included studies and published systematic reviews was also performed. The Cochrane Collaboration Risk of Bias Tool was used to assess the quality of the included studies. A random effects model meta-analyses was applied. Heterogeneity of outcomes between the studies was assessed using both the ?2 test and the I2 statistic. RESULTS:Of 955 records identified in the search, 392 duplicates were removed, and nine studies met the inclusion criteria. Seven studies were randomised controlled trial (RCTs) and two were quasi-experimental in design. Eight were conducted in the United States. The interventions included peer counselling, telephone support, massage, gift packs, financial incentive and antenatal education. Most studies included a combination of strategies, peer counselling being the most common. A meta-analysis of four of nine included studies did not detect a difference in rate of exclusive breastfeeding to 3 months postpartum (RR 1.44; 95% CI 0.82, 2.55; p?=?0.204). This review is limited by the relatively few studies which met the inclusion criteria and the small sample sizes of most included studies. High rates of attrition and formula supplementation among the participants made it difficult to detect a statistically significant effect. Consistency in follow up times would enable more studies to be included in a meta-analysis. CONCLUSIONS:Peer counselling was the most promising strategy associated with higher rates of exclusive breastfeeding. However, further studies are needed to understand the breastfeeding experiences of young mothers. Young mothers should be targeted specifically in intervention studies.

Dataset Information

The Philani MOVIE study: a cluster-randomized controlled trial of a mobile video entertainment-education intervention to promote exclusive breastfeeding in South Africa.

Publications

The Philani MOVIE study: a cluster-randomized controlled trial of a mobile video entertainment-education intervention to promote exclusive breastfeeding in South Africa.

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