HIV/AIDS Nutritional, Metabolic, Endocrine
Conditions
Interventions
Control Group
Time Restricted Eating
Sponsors
University of Cape Town
Groote Schuur Hospital Diabetes Centre
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: * Women living with HIV; * 20-45 years of age; * BMI =25 kg/m2; * Participants should just have initiated DTG-based ART or have been on DTG for maximum 24 month.
Exclusion criteria
Exclusion criteria: • Have active/unstable medical conditions influencing body weight or glycemic control; • Have severe eating disorders, current major depression, schizophrenia and bipolar disorder, or other major psychiatric conditions; • Breastfeeding, pregnant or wish to become pregnant within 1 year; • Post-menopausal; • Have an alcohol or drug addiction or be on treatment with Antabus; • Have a COVID-19 positive test in the past 1 month or any current symptoms suggestive of COVID-19; • Have excessive alcohol intake; • Have experienced weight loss of > 5% in past 6 months; • Have inflammatory bowel diseases (Crohn`s disease or ulcerative colitis) or other diseases associated with malabsorption; • Have tuberculosis, helminth infection, or hepatitis B/C; • Use medications such as glucocorticoids, hydrochlorothiazide and beta-blockers • At the same time participate in another intervention study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight reported in kilograms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting glucose, insulin and HbA1c concentrations;Estimates of insulin sensitivity and insulin secretion from an oral glucose tolerance test.;Blood pressure and resting heart rate;Appetite and hunger using a visual analogue scale and circulating appetite hormones;Systemic inflammatory markers ;Body composition including fat mass and fat-free soft tissue mass, waist circumference and hip circumference.;Dietary intake based on quantified food frequency questionnaire.;Sleep quality and physical activity based on questionnaire.;Compliance using daily self report eating windows. ;Sociodemographic characteristics based on questionnaire.;Food insecurity and food access based on questionnaire.;Medical and family history of disease and treatment based on questionnaire.;Process evaluation and program monitoring using a qualitative research approach, such as focus group discussions and key informant interviews ;Quality of life and self-efficacy based on questionnaire. | — |
Countries
South Africa
Contacts
Public ContactJoel ;Amy Dave;Mendham
Head of Division of Endocrinology University of Cape Town ;Research Fellow University of the Witwatersrand
Outcome results
None listed