Complex intervention to optimise adolescent BMI pre-conception to address the double burden of malnutrition: A RCT in rural and urban South Africa

Throughout the world the numbers of people with non-communicable diseases (NCDs), like type 2 diabetes and high blood pressure, are increasing. The risk of developing diabetes is associated with being poorly nourished as a child then becoming obese later in life, being inactive, having a poor-quality diet, as well as influenced by genetic inheritance and poor intra-uterine growth. Low- and middle-income countries, like South Africa, have fast-growing numbers with NCDs yet health systems are struggling to cope with the ongoing burden of infectious disease (including HIV/AIDS and TB). We have shown that in rural and urban South Africa a third or more young women are either overweight or obese by 20 years of age; while the problem of stunted growth is stubbornly persistent. Five to eight percent of 7 to 15 year olds already show early warning signs for the development of diabetes. To combat an increasing prevalence of NCDs, it has been suggested that improving adolescent nutritional status may be a successful strategy, and that developing and evaluating pre-pregnancy interventions that promote nutrition and healthy behaviours in poor communities where childbearing tends to start at a younger age, may be part of the solution. Sub-Saharan Africa is the only region worldwide where the number of adolescents is predicted to grow, but it also faces a poor adolescent health profile. To-date, we are unclear about how best to intervene to improve the nutritional status of adolescents in low- or middle-income countries. Our extensive formative and pilot trial research, has informed the development of an intervention targeting adolescent girls who reflect the double burden of malnutrition. The trial will enrol 1248 underweight or overweight/obese girls aged 14-19y from two-suitable settings in South Africa, one rural and one urban, using age- and sex-appropriate cut-offs. After baseline assessment and randomisation, trial participants will be reassessed after at least 18 months follow-up. If a participant becomes pregnant in this follow-up period, the reassessment will be carried out early in her pregnancy (<18weeks), and additional measures and antenatal clinic data will be collected during the pregnancy and from the infant at birth. The trial will include process and economic evaluations. This approach will allow us to assess the effects of our intervention - and whether there are grounds for a major expansion (scale-up). The trial will employ and train community health workers (CHWs) to work with adolescents and their primary caregiver to address sub-optimal nutrition by: (i) promoting healthy behaviours and improving diets; (ii) providing a multi-micronutrient supplement to combat deficiencies, particularly anaemia; (iii) providing the primary caregiver with a conditional cash transfer to encourage and enable better household dietary diversity within the context of food insecurity and (iv) supporting adolescent girls who become pregnant to use antenatal care services earlier in their pregnancies and more frequently. CHWs will be trained in 'Healthy Conversation Skills', a set of skills to support behaviour change specifically developed and tested for use with socioeconomically disadvantaged women to improve their confidence so that they can achieve their health goals. CHWs will apply these skills in the rural and urban sites over the trial period, building relationships with adolescents and their families to encourage healthier adolescent lifestyles. The intervention is flexible and will focus on the most challenging areas for each participant. Health literacy seeks to increase adolescent access to health information, and develop their ability to use this information effectively. Adolescents who become pregnant will be further supported by CHWs to access and attend antenatal services, facilitate their caregiver's involvement, and reinforce optimal individual health during pregnancy.