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有关，然后在以后的生活中变得肥胖，不活跃，饮食质量差，以及受遗传和子宫内生长不良的影响。南非等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科普传染病（包括艾滋病毒/艾滋病和结核病）的持续负担。我们已经表明，在南非的农村和城市，三分之一或更多的年轻妇女在20岁之前超重或肥胖;而发育迟缓的问题仍然顽固存在。7%至15奥尔兹中有5%至8%已经出现糖尿病的早期预警信号，为了应对非传染性疾病日益增加的流行，有人建议改善青少年的营养状况可能是一项成功的战略，并建议制定和评估孕前干预措施，在生育年龄往往较低的贫困社区促进营养和健康行为，可能是解决方案的一部分。撒哈拉以南非洲是全世界青少年人数预计将增长的唯一区域，但它也面临着青少年健康状况不佳的问题。到目前为止，我们还不清楚如何最好地干预，以改善青少年的营养状况在低收入或中等收入国家。我们广泛的形成和试点试验研究，为制定针对青春期女孩谁反映营养不良的双重负担的干预。该试验将招募1248名体重不足或超重/肥胖的14- 19岁女孩，来自南非的两个合适的环境，一个农村和一个城市，使用年龄和性别适当的截止值。基线评估和随机化后，将在至少18个月随访后重新评估试验受试者。如果受试者在该随访期内怀孕，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诊所数据。试验将包括工艺和经济评估。这一方法将使我们能够评估我们干预的效果--以及是否有理由进行大规模扩展（扩大规模）。该试验将雇用和培训社区卫生工作者，与青少年及其主要照顾者合作，通过以下方式解决营养不良问题：（一）促进健康行为和改善饮食;（二）提供多种微量营养素补充剂，以消除营养不足，特别是贫血;（三）向主要照顾者提供有条件的现金转移，以鼓励和促进在粮食不安全的情况下改善家庭饮食多样性及（iv）支持怀孕少女在怀孕初期及更频密地使用产前护理服务。社区卫生工作者将接受“健康对话技能”培训，这是一套专门为社会经济处境不利的妇女开发和测试的支持行为改变的技能，以提高她们的信心，使她们能够实现自己的健康目标。社区卫生工作者将在试验期间在农村和城市地区应用这些技能，与青少年及其家庭建立关系，鼓励青少年更健康的生活方式。干预是灵活的，将侧重于每个参与者最具挑战性的领域。健康知识普及旨在增加青少年获得健康信息的机会，并培养他们有效使用这些信息的能力。社区卫生工作者将进一步支持怀孕的青少年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.