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Ntshembo (Hope) Trial

Intervention to optimise change in BMI of adolescent pre-conception to address the double burden of malnutrition: An RCT in rural and urban South Africa

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
PACTR
Registry ID
PACTR202201638897606
Enrollment
1248
Registered
2022-01-14
Start date
2021-07-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional, Metabolic, Endocrine

Interventions

Control arm

Sponsors

Wits Health Consortium University of the Witwatersrand
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: -Adolescent girls and young women who are underweight (defined as BMI 91st percentile) -overweight/obese (defined as BMI > 91st percentile for age by the WHO 2007 international reference) -Adolescent girls and young women aged 14-19 years -HIV negative -in school grades 8-11 -Adolescent girls and young women who are nulliparous - Presence of a primary female caregiver of the index adolescent participant resident in the same household

Exclusion criteria

Exclusion criteria: -Girls with Type-1 diabetes -Previously identified severe intellectual disability -Evidence of severe depression based on a PHQ9 score of 20 and above (PHQ9 is used extensively in South Africa to monitor the severity of depression) -Adolescents screened HIV positive (However, they will be invited to participate in a sub-study and receive the intervention arm components, to provide important formative insights on a special population).

Design outcomes

Primary

MeasureTime frame
Change in BMI standard deviation score (SDS) aligned to the target direction – i.e. increase in BMI for underweight, decrease in BMI for overweight/obese

Secondary

MeasureTime frame
In the non-pregnant intervention group, blood pressure will be a key secondary outcome and together with other metabolic outcomes will be compared with measurements in non-pregnant controls. For those in the intervention group who become pregnant, maternal glucose concentrations around 28 weeks and neonatal adiposity data at delivery (sum of skin folds and ponderal index) will be compared with control pregnant participants and their offspring.

Countries

South Africa

Contacts

Public ContactShane Norris

Principle Investigator

Shane.Norris@wits.ac.za+27829282381

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026