tshembo (Hope) Trial

Phase 2

• Conditions: Nutritional, Metabolic, Endocrine

• Registration Number: PACTR202201638897606
• Lead Sponsor: Wits Health Consortium University of the Witwatersrand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-02
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 1248

Inclusion Criteria

Adolescent girls and young women who are underweight (defined as BMI < 9th percentile for age by the WHO 2007 international reference) (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

-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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.