Recruiting and engaging new mothers in nutrition research studies: lessons from the Australian NOURISH randomised controlled trial

Background: Despite important implications for the budgets, statistical power and generalisability of research findings, detailed reports of recruitment and retention in randomised controlled trials (RCTs) are rare. The NOURISH RCT evaluated a community-based intervention for first-time mothers that promoted protective infant feeding practices as a primary prevention strategy for childhood obesity. The aim of this paper is to provide a detailed description and evaluation of the recruitment and retention strategies used. Methods: A two stage recruitment process designed to provide a consecutive sampling framework was used. First time mothers delivering healthy term infants were initially approached in postnatal wards of the major maternity services in two Australian cities for consent to later contact (Stage 1). When infants were about four months old mothers were re-contacted by mail for enrolment (Stage 2), baseline measurements (Time 1) and subsequent random allocation to the intervention or control condition. Outcomes were assessed at infant ages 14 months (Time 2) and 24 months (Time 3). Results: At Stage 1, 86% of eligible mothers were approached and of these women, 76% consented to later contact. At Stage 2, 3% had become ineligible and 76% could be recontacted. Of the latter, 44% consented to full enrolment and were allocated. This represented 21% of mothers screened as eligible at Stage 1. Retention at Time 3 was 78%. Mothers who did not consent or discontinued the study were younger and less likely to have a university education. Conclusions: The consent and retention rates of our sample of first time mothers are comparable with or better than other similar studies. The recruitment strategy used allowed for detailed information from non-consenters to be collected; thus selection bias could be estimated. Recommendations for future studies include being able to contact participants via mobile phone (particular text messaging), offering home visits to reduce participant burden and considering the use of financial incentives to support participant retention

Association between infant feeding patterns and diarrhoeal and respiratory illness: A cohort study in Chittagong, Bangladesh

Background In developing countries, infectious diseases such as diarrhoea and acute respiratory infections are the main cause of mortality and morbidity in infants aged less than one year. The importance of exclusive breastfeeding in the prevention of infectious diseases during infancy is well known. Although breastfeeding is almost universal in Bangladesh, the rates of exclusive breastfeeding remain low. This cohort study was designed to compare the prevalence of diarrhoea and acute respiratory infection (ARI) in infants according to their breastfeeding status in a prospective cohort of infants from birth to six months of age. Methods A total of 351 pregnant women were recruited in the Anowara subdistrict of Chittagong. Breastfeeding practices and the 7-day prevalence of diarrhoea and ARI were recorded at monthly home visits. Prevalences were compared using chi-squared tests and logistic regression. Results A total of 272 mother-infant pairs completed the study to six months. Infants who were exclusively breastfed for six months had a significantly lower 7-day prevalence of diarrhoea [AOR for lack of EBF = 2.50 (95%CI 1.10, 5.69), p = 0.03] and a significantly lower 7-day prevalence of ARI [AOR for lack of EBF = 2.31 (95%CI 1.33, 4.00), p < 0.01] than infants who were not exclusively breastfed. However, when the association between patterns of infant feeding (exclusive, predominant and partial breastfeeding) and illness was investigated in more detail, there was no significant difference in the prevalence of diarrhoea between exclusively [6.6% (95% CI 2.8, 10.4)] and predominantly breastfed infants [3.7% (95% CI 0.09, 18.3), (p = 0.56)]. Partially breastfed infants had a higher prevalence of diarrhoea than the others [19.2% (95% CI 10.4, 27.9), (p = 0.01)]. Similarly, although there was a large difference in prevalence in acute respiratory illness between exclusively [54.2% (95%CI 46.6, 61.8)] and predominantly breastfed infants [70.4% (95%CI 53.2, 87.6)] there was no significant difference in the prevalence (p = 0.17). Conclusion The findings suggest that exclusive or predominant breastfeeding can reduce rates of morbidity significantly in this region of rural Bangladesh

Estimating the prevalence of exclusive breastfeeding with data from household surveys : measurement issues and options

The importance of breastfeeding for infant and maternal health is well established. The World Health Organization recommends that all infants be exclusively breastfed until they reach 6 months of age. The standard indicator to measure adherence to this criterion is the percentage of children aged 0–5 months who are currently being exclusively breastfed. This paper proposes supplementary measures that are easily calculated with existing survey data. First, for an accurate assessment of the WHO recommendation, we estimate the percentage of infants who are being exclusively breastfed at the exact age of 6 months. Second, an adjustment is proposed for prelacteal feeding. These two modifications, separately and in combination, are applied to data from 31 low-and middle-income countries that have participated in the Demographic and Health Surveys Program since 2015. There is considerable variation in the effects across countries. The modifications use existing data to provide a more accurate estimate than the standard indicator of the achievement of the exclusive breastfeeding until 6 months recommendation

Prevalence of Exclusive Breastfeeding in Bangladesh and Its Association with Diarrhoea and Acute Respiratory Infection: Results of the Multiple Indicator Cluster Survey 2003

The objective of this study was to investigate the association between the prevalence of exclusive breastfeeding and morbidity (diarrhoeal diseases and acute respiratory infection) in infants aged 0-3 month(s) using the Multiple Indicator Cluster Survey (MICS) 2003 data from Bangladesh. The study population included 1,633 infants aged 0-3 month(s). The prevalence of diarrhoea and acute respiratory infection was compared using the chi-square tests between infants aged 0-3 month(s) who were exclusively breastfed and infants who were not exclusively breastfed. Logistic regression was used to adjust for confounders and for calculating adjusted odds ratios. To adjust for cluster sampling and reduced variability, the adjusted chi-square value was divided by the design effect, and a re-estimated p value was calculated. The prevalence of diarrhoea and acute respiratory infection in this sample of 0-3-month old infants in Bangladesh was 14.3% and 31.2% respectively. The prevalence of both illnesses was significantly associated with lack of exclusive breastfeeding. The adjusted odds ratio for diarrhoea was 0.69 (95% confidence interval [CI] 0.49-0.98, p=0.039), and the adjusted odds ratio for acute respiratory infection was also 0.69 (95% CI 0.54-0.88, p=0.003). Only 192 infants (11.7% of total sample) were exclusively breastfed at the time of interview, and 823 infants (50.3%) were never exclusively breastfed. The prevalence of prelacteal feeding was 66.6%. The results confirmed a protective effect of exclusive breastfeeding against infectious diseases-related morbidity in infancy and showed that frequently-collected cross-sectional datasets could be used for estimating effects. The low prevalence of exclusive breastfeeding in Bangladesh needs to be improved to decrease child morbidity

Prevalence of Exclusive Breastfeeding in Bangladesh and Its Association with Diarrhoea and Acute Respiratory Infection: Results of the Multiple Indicator Cluster Survey 2003

The objective of this study was to investigate the association between the prevalence of exclusive breastfeeding and morbidity (diarrhoeal diseases and acute respiratory infection) in infants aged 0-3 month(s) using the Multiple Indicator Cluster Survey (MICS) 2003 data from Bangladesh. The study population included 1,633 infants aged 0-3 month(s). The prevalence of diarrhoea and acute respiratory infection was compared using the chi-square tests between infants aged 0-3 month(s) who were exclusively breastfed and infants who were not exclusively breastfed. Logistic regression was used to adjust for confounders and for calculating adjusted odds ratios. To adjust for cluster sampling and reduced variability, the adjusted chi-square value was divided by the design effect, and a reestimated p value was calculated. The prevalence of diarrhoea and acute respiratory infection in this sample of 0-3-month old infants in Bangladesh was 14.3% and 31.2% respectively. The prevalence of both illnesses was significantly associated with lack of exclusive breastfeeding. The adjusted odds ratio for diarrhoea was 0.69 (95% confidence interval [CI] 0.49-0.98, p=0.039), and the adjusted odds ratio for acute respiratory infection was also 0.69 (95% CI 0.54-0.88, p=0.003). Only 192 infants (11.7% of total sample) were exclusively breastfed at the time of interview, and 823 infants (50.3%) were never exclusively breastfed. The prevalence of prelacteal feeding was 66.6%. The results confirmed a protective effect of exclusive breastfeeding against infectious diseases-related morbidity in infancy and showed that frequently-collected cross-sectional datasets could be used for estimating effects. The low prevalence of exclusive breastfeeding in Bangladesh needs to be improved to decrease child morbidity

Unpacking the Behavioural Components and Delivery Features of Early Childhood Obesity Prevention Interventions in the TOPCHILD Collaboration: A Systematic Review and Intervention Coding Protocol

INTRODUCTION: Little is known about how early (eg, commencing antenatally or in the first 12 months after birth) obesity prevention interventions seek to change behaviour and which components are or are not effective. This study aims to (1) characterise early obesity prevention interventions in terms of target behaviours, delivery features and behaviour change techniques (BCTs), (2) explore similarities and differences in BCTs used to target behaviours and (3) explore effectiveness of intervention components in preventing childhood obesity. METHODS AND ANALYSIS: Annual comprehensive systematic searches will be performed in Epub Ahead of Print/MEDLINE, Embase, Cochrane (CENTRAL), CINAHL, PsycINFO, as well as clinical trial registries. Eligible randomised controlled trials of behavioural interventions to prevent childhood obesity commencing antenatally or in the first year after birth will be invited to join the Transforming Obesity in CHILDren Collaboration. Standard ontologies will be used to code target behaviours, delivery features and BCTs in both published and unpublished intervention materials provided by trialists. Narrative syntheses will be performed to summarise intervention components and compare applied BCTs by types of target behaviours. Exploratory analyses will be undertaken to assess effectiveness of intervention components. ETHICS AND DISSEMINATION: The study has been approved by The University of Sydney Human Research Ethics Committee (project no. 2020/273) and Flinders University Social and Behavioural Research Ethics Committee (project no. HREC CIA2133-1). The study\u27s findings will be disseminated through peer-reviewed publications, conference presentations and targeted communication with key stakeholders. PROSPERO REGISTRATION NUMBER: CRD42020177408

Transforming Obesity Prevention for CHILDren (TOPCHILD) Collaboration: Protocol for a Systematic Review with Individual Participant Data Meta-Analysis of Behavioural Interventions for the Prevention of Early Childhood Obesity

INTRODUCTION: Behavioural interventions in early life appear to show some effect in reducing childhood overweight and obesity. However, uncertainty remains regarding their overall effectiveness, and whether effectiveness differs among key subgroups. These evidence gaps have prompted an increase in very early childhood obesity prevention trials worldwide. Combining the individual participant data (IPD) from these trials will enhance statistical power to determine overall effectiveness and enable examination of individual and trial-level subgroups. We present a protocol for a systematic review with IPD meta-analysis to evaluate the effectiveness of obesity prevention interventions commencing antenatally or in the first year after birth, and to explore whether there are differential effects among key subgroups. METHODS AND ANALYSIS: Systematic searches of Medline, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycInfo and trial registries for all ongoing and completed randomised controlled trials evaluating behavioural interventions for the prevention of early childhood obesity have been completed up to March 2021 and will be updated annually to include additional trials. Eligible trialists will be asked to share their IPD; if unavailable, aggregate data will be used where possible. An IPD meta-analysis and a nested prospective meta-analysis will be performed using methodologies recommended by the Cochrane Collaboration. The primary outcome will be body mass index z-score at age 24±6 months using WHO Growth Standards, and effect differences will be explored among prespecified individual and trial-level subgroups. Secondary outcomes include other child weight-related measures, infant feeding, dietary intake, physical activity, sedentary behaviours, sleep, parenting measures and adverse events. ETHICS AND DISSEMINATION: Approved by The University of Sydney Human Research Ethics Committee (2020/273) and Flinders University Social and Behavioural Research Ethics Committee (HREC CIA2133-1). Results will be relevant to clinicians, child health services, researchers, policy-makers and families, and will be disseminated via publications, presentations and media releases. PROSPERO REGISTRATION NUMBER: CRD42020177408

Lessons learned from implementation of a demonstration program to reduce the burden of anemia and hookworm in women in Yen Bai Province, Viet Nam

Background Iron deficiency, anemia and hookworm disease are important public health problems for women of reproductive age living in developing countries and affect the health of newborns and infants. Iron supplementation and deworming treatment are effective in addressing these problems in both pregnant and non-pregnant women. Daily iron supplementation and deworming after the first trimester is recommended for pregnant women although these programs usually do not operate efficiently or effectively. Weekly iron-folic acid supplementation and regular deworming for non-pregnant women may be a viable approach for improving iron status and preventing anemia during the reproductive years. Addressing these diseases at a population level before women become pregnant could significantly improve women's health before and during pregnancy, as well as their infants' growth and development. Methods and Results This paper describes the major processes undertaken in a demonstration intervention of preventive weekly iron-folic acid supplementation with regular deworming for all 52,000 women aged 15–45 years in two districts of Yen Bai province, in northern Viet Nam. The intervention strategy included extensive consultation with community leaders and village, commune, district and provincial health staff, and training for village health workers. Distribution of the drugs was integrated with the existing health service infrastructure and the village health workers were the direct point of contact with women. Iron-folic acid tablets and deworming treatment were provided free of charge from May 2006. An independent Vietnamese NGO was commissioned to evaluate compliance and identify potential problems. The program resulted in effective distribution of iron-folic acid tablets and deworming treatment to all villages in the target districts, with full or partial compliance of 85%. Conclusion Training for health staff, the strong commitment of all partners and the use of appropriate educational materials led to broad support for weekly iron-folic acid supplementation and high participation in the regular deworming days. In March 2008 the program was expanded to all districts in the province, a target population of approximately 250,000 WRA, and management was handed over to provincial authorities