Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202302484999720 Date of Approval: 08/02/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Exploring time-restricted eating as a strategy to prevent weight gain in HIV-infected South Africans (TESSA)
Official scientific title Exploring time-restricted eating as a strategy to prevent weight gain in HIV-infected South Africans (TESSA)
Brief summary describing the background and objectives of the trial 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 groups Secondary 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
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TESSA
Disease(s) or condition(s) being studied Infections and Infestations,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 20/03/2023
Actual trial start date 12/04/2023
Anticipated date of last follow up 20/12/2024
Actual Last follow-up date 20/12/2024
Anticipated target sample size (number of participants) 152
Actual target sample size (number of participants) 93
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control Group Standard of Care 12 months Participants are to continue their DTG-based ART and will receive standard of care during their regular visits to the clinic. Participants are also advised to continue their daily eating and physical activity patterns. 76 Uncontrolled
Experimental Group Time Restricted Eating Daily alterations of eating window and nutritional information sessions every 3 months 12 months Participants in the time restricted eating (TRE) intervention group will 1) continue their DTG-based ART and will receive standard of care during their regular visits to the clinic, 2) Receive nutritional information sessions at baseline, 3, 6, 9 and 12 months, and 3) self-implement the TRE-based intervention. The TRE component advises participants to eat within the same time window (including foods/snacks and beverages (except for water)) each day. This component will be personalised to ensure an 8-10 hour eating window, which commonly equates to an approximate 4 hour reduction on each participants habitual eating window. 76
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
* 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. • 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 Adult: 19 Year-44 Year 20 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/11/2021 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Old main road building, Groote Schuur Hospital, Observatory Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/10/2022 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Old main road building, Groote Schuur Hospital, Observatory Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Body weight reported in kilograms. Every month from baseline to 12 months
Secondary Outcome Fasting glucose, insulin and HbA1c concentrations Baseline, 3, 6, 9 and 12 months
Secondary Outcome Estimates of insulin sensitivity and insulin secretion from an oral glucose tolerance test. Baseline, 6 and 12 months
Secondary Outcome Blood pressure and resting heart rate Every month from baseline to 12 months
Secondary Outcome Appetite and hunger using a visual analogue scale and circulating appetite hormones Baseline, 3, 6, 9 and 12 months
Secondary Outcome Systemic inflammatory markers Baseline, 3, 6, 9 and 12 months
Secondary Outcome Body composition including fat mass and fat-free soft tissue mass, waist circumference and hip circumference. Every month from baseline to 12 months
Secondary Outcome Dietary intake based on quantified food frequency questionnaire. Baseline, 6 and 12 months
Secondary Outcome Sleep quality and physical activity based on questionnaire. Baseline, 6 and 12 months
Secondary Outcome Compliance using daily self report eating windows. Every month from baseline to 12 months
Secondary Outcome Sociodemographic characteristics based on questionnaire. Baseline, 6 and 12 months
Secondary Outcome Food insecurity and food access based on questionnaire. Baseline, 6 and 12 months
Secondary Outcome Medical and family history of disease and treatment based on questionnaire. Baseline, 6 and 12 months
Secondary Outcome Process evaluation and program monitoring using a qualitative research approach, such as focus group discussions and key informant interviews Ongoing throughout the 12 month intervention
Secondary Outcome Quality of life and self-efficacy based on questionnaire. Baseline, 6 and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Divisions of Physiological Sciences Sports Science Institute of South Africa, University of Cape Town, Boundary Road, Newlands Cape Town 7700 South Africa
Ubuntu ART clinic Community Health Centre, Site B, Khayelitsha Cape Town 7784 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
European Foundation for the Study of Diabetes Rheindorfer Weg 3 Dusseldorf 40591 Germany
National Research Foundation South Gate CSIR Complex, Meiring Naude Road, Brummeria Pretoria South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Cape Town Groote Schuur Hospital, Observatory Cape Town South Africa University
Primary Sponsor Steno Diabetes Center Copenhagen Borgmester Ib Juuls Vej 83 Copenhagen 2730 Denmark Hospital
Secondary Sponsor Groote Schuur Hospital Diabetes Centre Groote Schuur Hospital, Main road Cape Town South Africa Hospital
COLLABORATORS
Name Street address City Postal code Country
Dirk Lund Chistensen Postboks 2099, Oster Farimagsgade 5 opg Copenhagen Denmark
Andre Pascal Kengne Francie van Zijl Drive Cape Town South Africa
Ole Oelsen Anna van Saksenlaan The Hague Netherlands
Jonas Salling Quist Borgmester Ib Juuls Vej 83 Copenhagen Denmark
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kristine Faerch kristine.faerch@regionh.dk +4530913061 Borgmester Ib Juuls Vej 83
City Postal code Country Position/Affiliation
Copenhagen 2730 Denmark Research leader Steno Diabetes Center Copenhagen
Role Name Email Phone Street address
Principal Investigator Julia Goedecke julia.goedecke@mrc.ac.za +27828255616 Francie van Zijl Drive
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Chief Specialist Scientist South African Medical Research Council
Role Name Email Phone Street address
Public Enquiries Joel Dave joeldave@endocrine.co.za 000214045007 Groote Schuur Hospital
City Postal code Country Position/Affiliation
Cape Town South Africa Head of Division of Endocrinology University of Cape Town
Role Name Email Phone Street address
Public Enquiries Amy Mendham amy.mendham@uct.ac.za +27723879889 Boundary Road
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa Research Fellow University of the Witwatersrand
Role Name Email Phone Street address
Scientific Enquiries Amy Mendham amy.mendham@uct.ac.za +27723879889 Boundary Road
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa Research Fellow University of the Witwatersrand
Role Name Email Phone Street address
Scientific Enquiries Louise Groth Grunnet Louise.groth.grunnet.02@regionh.dk +4560671704 Borgmester Ib Juuls Vej 83
City Postal code Country Position/Affiliation
Copenhagen 2730 Denmark Senior Scientist Steno Diabetes Center Copenhagen
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Within the 12 months following trial completion a summary of results will be made publicly available. These results will include a publication on the study protocol, a CONSORT diagram of the study, and the reporting of all outcome measures: A table of data for each primary and secondary outcome measure and their respective measurement of precision by group assignment, including the results of appropriate statistical analyses. A summary of qualitative outcomes for intervention process evaluation will be described. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Once published, data will be immediately available for sharing and end 5 years following article publication. Unpublished data will be shared 3 years after the completion of the study and will end 5 years following study conclusion. Proposals should be directed to amy.mendham@uct.ac.za. To gain access, data requestors will need to sign a data access agreement. Data will be shared with researchers who provide a methodologically sound proposal.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 08/05/2023 Updating details start date 12 Apr 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 15/02/2024 Date reflective of 12 months post the last recruitment intake. 27 Sep 2024 20 Dec 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 02/01/2025 Reporting on final completed date of the trial 20 Dec 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 13/03/2025 Providing additional detail for updated participant numbers that started the trial. 93
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 08/05/2023 Updating details to now recruiting Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 15/02/2024 Progress update Recruiting Closed to recruitment,follow-up continuing
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 02/01/2025 Reporting on final completed date of the trial Closed to recruitment,follow-up continuing Completed
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 08/05/2023 An oral glucose tolerance test will be completed at 6 months to ensure that we capture changes in glycaemic control throughout the intervention. Secondary Outcome, Estimates of insulin sensitivity and insulin secretion from an oral glucose tolerance test., Baseline and 12 months Secondary Outcome, Estimates of insulin sensitivity and insulin secretion from an oral glucose tolerance test., Baseline, 6 and 12 months
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 06/02/2023 Ethics Renewal 2022-2023 TRUE, University of Cape Town Human Research Ethics Committee, Old main road building, Groote Schuur Hospital, Observatory, Cape Town, 7925, South Africa, , 29 Oct 2022, 0214066492, hrec-enquiries@uct.ac.za, 24283_23125_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 06/02/2023 Included details based on the WHO requirements. Quantitative data including clinical measures and questionnaire data. Qualitative data will include transcripts of focus group discussion and in-depth interviews Within the 12 months following trial completion a summary of results will be made publicly available. These results will include a publication on the study protocol, a CONSORT diagram of the study, and the reporting of all outcome measures: A table of data for each primary and secondary outcome measure and their respective measurement of precision by group assignment, including the results of appropriate statistical analyses. A summary of qualitative outcomes for intervention process evaluation will be described.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 06/02/2023 more specific start and end dates provided Once published, data will be immediately available for sharing. Unpublished data will be shared 3 years after the completion of the study. Once published, data will be immediately available for sharing and end 5 years following article publication. Unpublished data will be shared 3 years after the completion of the study and will end 5 years following study conclusion.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 06/02/2023 more detail based on WHO Proposals should be directed to amy.mendham@uct.ac.za . To gain access, data requestors will need to sign a data access agreement. Proposals should be directed to amy.mendham@uct.ac.za. To gain access, data requestors will need to sign a data access agreement. Data will be shared with researchers who provide a methodologically sound proposal.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 06/02/2023 included statistical analysis plan and clinical study report as these will be provided in the results within the 12 month following trial completion Study Protocol, Informed Consent Form Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report