Exploring time-restricted eating as a strategy to prevent weight gain in HIV-infected South Africans (TESSA)
- Disease/Condition
- Infections and Infestations; Nutritional, Metabolic, Endocrine
- Primary sponsor
- University of Cape Town ; Steno Diabetes Center Copenhagen; Groote Schuur Hospital Diabetes Centre
- Funder
- European Foundation for the Study of Diabetes; National Research Foundation
- Location
- South Africa
- Phase
- Not Applicable
- Start date
- Apr 12, 2023
- End date
- Jan 01, 1900
South Africa presents with a double burden of non-communicable and communicable diseases, with as many as 7.7 million people living with human immunodeficiency virus (HIV), of which 62% receive antiretroviral (ART) treatment. The preferred first-line ART regimen contains dolutegravir (DTG), which was introduced in the public health care system in 2019. DTG-based treatment increases body weight, which may compound the high rates of obesity and associated non-communicable diseases, including T2D. Dietary strategies are difficult to implement in South African settings due to widespread food insecurity. In contrast to traditional dietary interventions, time-restricted eating (TRE) does not require that participants eat specific foods, but rather restrict their eating window to ~8-10 hours in the day. TRE has been suggested as a feasible strategy to reduce body weight and improve cardiometabolic health in individuals with overweight and obesity. The overall aim of the project is to investigate the effects of a TRE-based intervention on body weight and risk factors for type 2 diabetes in women living with overweight/obesity and HIV and who have initiated DTG-based ART. Primary objective 1. Measure changes in body weight over the 12-months intervention between the two groupsSecondary objective 2. Measures changes over the 12 months between the two groups in:- Fasting glucose, insulin and HbA1c concentrations,- Insulin sensitivity, insulin secretion and insulin resistance,- Blood pressure and resting heart rate- Appetite and appetite hormones- Systemic inflammation- Body composition and anthropometry- Dietary behaviours- Social support - Sleep and physical activity- Compliance- Program monitoring and - Sociodemographic characteristics- Self-efficacy - Quality of Life - Food insecurity - Medical and family history of disease
- Registry
- Pan Africa Clinical Trials Registry
- Trial ID
- PACTR202302484999720
- Type
- Non-Device Trial
Access comprehensive clinical trial information for PACTR202302484999720 through Pure Global AI's free database. This Not Applicable trial is sponsored by University of Cape Town ; Steno Diabetes Center Copenhagen; Groote Schuur Hospital Diabetes Centre and is currently Recruiting. The study focuses on Infections and Infestations; Nutritional, Metabolic, Endocrine.
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