Exploring time-restricted eating as a strategy to prevent weight gain in HIV-infected South Africans (TESSA)

Not Applicable

Recruiting

• Conditions: HIV/AIDS; Nutritional, Metabolic, Endocrine

• Registration Number: PACTR202302484999720
• Lead Sponsor: niversity of Cape Town

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-17
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 152

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

•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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body weight reported in kilograms.

Secondary Outcome Measures

Name	Time	Method
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.