PACTR202201638897606
Not yet recruiting
Phase 2
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
Wits Health Consortium University of the Witwatersrand0 sites1,248 target enrollmentFebruary 2, 2021
ConditionsNutritional, Metabolic, Endocrine
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Nutritional, Metabolic, Endocrine
- Sponsor
- Wits Health Consortium University of the Witwatersrand
- Enrollment
- 1248
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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).
Outcomes
Primary Outcomes
Not specified
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