Trials · 2026
Intervention to optimise body mass index in adolescents and address the triple burden of malnutrition-the Ntshembo (Hope) trial in rural and urban South Africa study: a study protocol for a randomised controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Norris S A, Micklesfield L K, Christofides N J, Crouch S H, Mathatha D E, Desmond C, Sharp S J, Ong K K, Tollman S M, Kahn K
Аннотация
INTRODUCTION: South Africa faces a complex health burden with burgeoning non-communicable diseases against a background of prevalent infection. The triple burden of malnutrition, comprising undernutrition alongside overweight/obesity and micronutrient deficiencies, is widespread and imposes risks for non-communicable diseases along the life course, especially among adolescent girls. We hypothesise that, by optimising nutrition and body mass index (BMI) of at-risk adolescent girls, we can realise a triple return on investment: improved nutritional status, reduced metabolic risk, and moderated pre-conception exposures to offset transgenerational risk for cardiometabolic disease.
METHODS AND ANALYSIS: We will enrol 1248 girls 14-19 years with either underweight or overweight defined using age-sex-appropriate BMI cut-offs living either in rural or urban South Africa. After baseline assessments and randomisation, participants will be reassessed at 18-24 months follow-up. If a participant becomes pregnant, further assessments will be conducted during pregnancy (< 28 weeks) and postnatally. We will include both process and economic evaluations. The primary outcome is change in BMI standard deviation score from baseline to follow-up aligned to the target direction, i.e. increase in BMI for underweight, decrease in BMI for overweight. Community health workers will deliver the intervention with both household and individual components. A conditional cash transfer will be provided to the household with guidance to improve dietary diversity. Health literacy material, a multi-micronutrient supplement, health screening and support management (for example anaemia; blood pressure; HIV; depression), and facilitating behaviour change to optimise nutrition, physical and mental health will be provided to the adolescent girl.
TRIAL REGISTRATION: The trial has been registered with the Pan African Clinical Trials Registry; identifier: PACTR202201638897606. Registered on 1st August 2022. https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=14656 .
METHODS AND ANALYSIS: We will enrol 1248 girls 14-19 years with either underweight or overweight defined using age-sex-appropriate BMI cut-offs living either in rural or urban South Africa. After baseline assessments and randomisation, participants will be reassessed at 18-24 months follow-up. If a participant becomes pregnant, further assessments will be conducted during pregnancy (< 28 weeks) and postnatally. We will include both process and economic evaluations. The primary outcome is change in BMI standard deviation score from baseline to follow-up aligned to the target direction, i.e. increase in BMI for underweight, decrease in BMI for overweight. Community health workers will deliver the intervention with both household and individual components. A conditional cash transfer will be provided to the household with guidance to improve dietary diversity. Health literacy material, a multi-micronutrient supplement, health screening and support management (for example anaemia; blood pressure; HIV; depression), and facilitating behaviour change to optimise nutrition, physical and mental health will be provided to the adolescent girl.
TRIAL REGISTRATION: The trial has been registered with the Pan African Clinical Trials Registry; identifier: PACTR202201638897606. Registered on 1st August 2022. https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=14656 .