tshembo (Hope) Trial
- Conditions
- Nutritional, Metabolic, Endocrine
- Registration Number
- PACTR202201638897606
- Lead Sponsor
- Wits Health Consortium University of the Witwatersrand
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 1248
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
-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
- Secondary Outcome Measures
Name Time Method