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

在世界各地，患有2型糖尿病和高血压等非传染性疾病的人数正在增加。患糖尿病的风险与儿童时期营养不良、晚年肥胖、不爱运动、饮食质量差、基因遗传和子宫内发育不良有关。像南非这样的低收入和中等收入国家的非传染性疾病患者数量迅速增长，但卫生系统正在努力应对传染病（包括艾滋病毒/艾滋病和结核病）的持续负担。我们已经表明，在南非农村和城市，三分之一或更多的年轻女性在20岁之前超重或肥胖；而增长迟缓的问题却顽固存在。在7岁到15岁的孩子中，有5%到8%的人已经出现了糖尿病发展的早期预警信号。为了应对日益普遍的非传染性疾病，有人建议，改善青少年营养状况可能是一项成功的战略，而制定和评估孕前干预措施，在往往较年轻开始生育的贫穷社区促进营养和健康行为，可能是解决办法的一部分。撒哈拉以南非洲是世界上唯一一个青少年人数预计会增长的地区，但它也面临着青少年健康状况不佳的问题。迄今为止，我们尚不清楚如何最好地干预以改善低收入或中等收入国家青少年的营养状况。我们广泛的形成性和试点试验研究为制定针对反映营养不良双重负担的少女的干预措施提供了信息。该试验将招募1248名体重过轻或超重/肥胖的女孩，年龄在14-19岁之间，来自南非的两个合适的环境，一个是农村，一个是城市，使用年龄和性别合适的截止值。在基线评估和随机化后，试验参与者将在至少18个月的随访后重新评估。如果参与者在此随访期间怀孕，将在其妊娠早期（<18周）进行重新评估，并在妊娠期间和婴儿出生时收集额外的测量和产前临床数据。试验将包括过程和经济评估。这种方法将使我们能够评估我们干预的效果——以及是否有理由大规模扩大（扩大规模）。该试验将雇用和培训社区卫生工作者（CHWs）与青少年及其主要照顾者合作，通过以下方式解决次优营养问题：(i)促进健康行为和改善饮食；（二）提供多种微量营养素补充剂，以对抗缺乏症，特别是贫血症；（三）向主要照顾者提供有条件的现金转移，以在粮食不安全的情况下鼓励和改善家庭饮食多样性；（四）支持怀孕的少女在怀孕早期和更频繁地使用产前保健服务。卫生保健员将接受“健康谈话技巧”方面的培训，这是一套支持改变行为的技能，专门为社会经济上处于不利地位的妇女开发和测试，以提高她们的信心，使她们能够实现健康目标。在试验期间，卫生保健员将在农村和城市站点应用这些技能，与青少年及其家庭建立关系，以鼓励更健康的青少年生活方式。干预是灵活的，将重点放在每个参与者最具挑战性的领域。卫生知识普及旨在增加青少年获得卫生信息的机会，并培养他们有效利用这些信息的能力。怀孕的青少年将得到保健员的进一步支持，以获得和参加产前服务，促进其照顾者的参与，并加强怀孕期间的最佳个人健康。

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.