Feasibility and pilot study of a complex community intervention to improve rural adolescent health

Throughout the world the numbers of people with non-communicable (NCDs) diseases, like type 2 diabetes and high blood pressure, are increasing. The risk of developing diabetes is associated with being poorly nourished as a child and then becoming obese later in life, being inactive, having a poor quality diet, as well as with genetic inheritance and poor growth in the womb. Low- and middle-income countries, like South Africa, have particularly fast-growing numbers of people with NCDs and have health systems already struggling to manage the burden of infectious diseases. We have shown that in rural South Africa a third of girls have growth faltering at one year of age, and a third of adolescents and young women are overweight or obese by 20 years of age. Five percent of 7 to 15 year olds already show early warning signs for the development of diabetes.

To combat the problem of 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 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 has the worst adolescent health profile. To date, we are still unclear about how best to intervene to improve nutritional status in adolescents in low- or middle-income countries.

Our extensive research over the last five years, has informed the development of an intervention targeting adolescent girls and boys. It will employ trained adolescent-focused community health workers (AHWs) to work with adolescents to address both underweight and obesity by: (i) promoting healthy behaviours and increasing their use of adolescent health services; (ii) encouraging better caregiver and friend support and increasing opportunities in the community to become more healthy; and (iii) supporting adolescent girls who become pregnant to use antenatal health services earlier in their pregnancies and more frequently.

This intervention aims to identify and reduce NCD risk in adolescents, and increase their use of health services through supporting behaviour change. AHWs 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 that they can achieve their health goals. AHWs will use these skills as the basis for their work in rural SA villages over two years, building relationships with adolescents and their families to encourage social support for healthier adolescent lifestyles. The intervention is flexible in its approach and will focus on the most relevant area of difficulty for each participant. AHWs will also involve their adolescent peer group in the village to promote health literacy. Health literacy will both increase adolescent access to health information and develop their ability to use this information effectively. AHWs will mobilise village community leaders to create greater opportunities to promote and support healthier lifestyles. Adolescents who become pregnant will be further supported by AHWs to access and regularly attend antenatal services, facilitate caregiver involvement, and reinforce optimal individual health (including weight gain) during pregnancy. Through these interventions we aim to reduce the incidence of low of high birthweight in the infants, as these have been associated with diabetes risk in later life.

The proposed development grant will enable us to complete a feasibility and pilot study in two villages to provide critical data to inform both the design and implementation of the trial.

The proposed intervention is already informed by extensive formative research (over 5 years; 25 publications) based on UK MRC Guidelines for Complex Interventions and supported by PI Norris' MRC/DfID African Research Leader award2. The formative evidence base includes: (i) a needs assessment with local stakeholders from multiple sectors, including adolescents; (ii) studies describing youth-friendly health services, and adolescent perceptions and use of these services, (iii) barriers to and facilitators of physical activity and dietary practices; (iv) child and adolescent growth, nutrition and metabolic disease risk surveys; (v) literature reviews and scoping of best practice interventions; (vi) analyses of Agincourt HDSS longitudinal surveillance data on fertility and childbearing patterns; (vii) formulation of behaviour change objectives; (viii) selection of theory-based methods and practical strategies appropriate for encouraging behaviour change in the target group; (ix) training of lay community workers in "healthy conversation skills"; (x) field studies to document variance in BMI across the target villages to inform power calculations.

However, the proposed pilot study will enable us to further identify important factors which may be important in assessing the feasibility (consenting, recruitment rates, protocol delivery, data collection processes, tracking metabolic and pregnancy outcomes), the acceptability of the intervention components (intervention material; AHWs) to the control and intervention populations and the villages, and to use this information to refine and strengthen the future trial design and implementation of the study.

South Africa's evolving burden of disease is complex due to: (i) persisting malnutrition (infant stunting reaching 40% in some rural areas); (ii) the highest prevalence of obesity in Sub-Saharan Africa; and (iii) rising rates of type 2 diabetes (T2D) - 14% of black adult women live with T2D. Efforts to address the paradoxical challenges of stunting in early childhood and escalating obesity, particularly in black South African women, have been largely unsuccessful.

Impact of project on problem: Planned intervention during adolescence for girls and boys, and in particular, before young women become pregnant in settings where childbearing is common before age 20y provides the best opportunity to impact effectively on an adolescent's future health and that of the mother's offspring. The project team has engaged fully with target communities, adolescents, and various stakeholders, including the health sector, to ensure buy-in, collaboration, affordability and sustainability. We envisage that this intervention will substantially reduce the risk of suboptimal or excessive weight gain in adolescents and contribute to lessening the present and future NCD burden in South Africa.

Trial will produce rigorous evidence: Including process and economic evaluations, which can inform potential later scale-up based on primary health care systems. Adolescents are a highly vulnerable and at-risk population for the onset of obesity, with potential lasting effects for themselves and on the next generation. Early interventions to improve adolescent nutritional status and health are likely to have a significant impact and be more cost-effective than intervening later in life.

The intervention has great potential to impact on and strengthen the public health system (collaboration and co-production): Rigorous evaluation using hard endpoints will provide evidence for intervention scale-up within primary health care systems in South Africa, regionally and in other middle- and low-income countries undergoing complex health and nutrition transitions. In particular, we aim to work with and support the current national health system to adapt to these new and unfamiliar challenges. Thus the partnership with the South African Department of Health (DOH) was initiated early in the intervention development and needs assessment to ensure the project's relevance, with co-creation and input, and importantly to lay the basis for potential take-up of the evidence to shape policy and practice. The findings, experience and insight from the process evaluation will, we expect, prove instrumental in informing the DOH's Primary Health Care Re-engineering initiatives with AHWs and form an essential part of the pathway towards economic and societal impact. Notably, findings from this trial should translate into current adolescent health practice. Key local and national members of the DOH are part of the established Community Advisory Group and Scientific Committee.

The planned development grant is crucial to provide pilot, feasibility and acceptability information to assist in the development of the trial and how the complex community intervention will be implemented.

In summary: impact of the trial will be through: (i) advancing our understanding on how to improve the nutritional status and health of adolescents living in poor communities; (ii) understanding how a pre-pregnancy intervention during adolescence may leverage health benefits for adolescent women and their offspring if they become pregnant; (iii) shaping Department of Health policy and practice around AHWs; and (iv) enabling bi-directional knowledge transfer between UK and SA researchers and students involved in the study.