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Exploring the effects of ime-restricted ating on body weight and associated cardiometabolic outcomes in outh frican women living with HIV (TESSA): protocol for a randomised controlled trial.

作者信息

Mendham Amy E, Goedecke Julia H, Heckens Lorena, Hoosen Fatima, Pico Majken Lillholm, Kengne Andre P, Christensen Dirk L, Olesen Ole F, Quist Jonas Salling, Dave Joel, Færch Kristine, Groth Grunnet Louise

机构信息

Riverland Academy of Clinical Excellence, Riverland Mallee Coorong Local Health Network, Berri, South Australia, Australia

Health through Physical Activity, Lifestyle and Sport Research Centre (HPALS), FIMS International Collaborating Centre of Sports Medicine, Division of Physiological Sciences, Department of Human Biology, University of Cape Town, Cape Town, Western Cape, South Africa.

出版信息

BMJ Open. 2024 Dec 3;14(12):e086203. doi: 10.1136/bmjopen-2024-086203.


DOI:10.1136/bmjopen-2024-086203
PMID:39627134
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11624751/
Abstract

INTRODUCTION: We codesigned an intervention with a low-resourced community with the aim to investigate the effects of time-restricted eating (TRE) on changes in body weight and associated cardiometabolic outcomes in South African women living with overweight/obesity and HIV who have initiated dolutegravir (DTG)-based antiretroviral therapy (ART). METHODS AND ANALYSIS: Women with overweight or obesity (body mass index ≥25 kg/m², no upper limit), aged 20-45 years, living with HIV and in a low-resourced community, and receiving DTG-based ART for less than 2 years will be recruited from a community healthcare centre in Khayelitsha, Cape Town (n=152). Participants will be randomised 1:1 to the TRE group (n=76) or standard of care control group (n=76) for 12 months. The TRE group will be required to restrict their eating window to ~8-10 hours/day and will receive nutritional information sessions at baseline and at 3, 6, 9 and 12 months. The primary outcome of body weight will be assessed at baseline and monthly. Cardiometabolic measures will be reported as secondary outcomes. At baseline, 6- and 12 months, an oral glucose tolerance test (to estimate insulin sensitivity and beta-cell function), questionnaires (sociodemographic, food insecurity, quality of life, social support and sleep quality) and a quantified food frequency questionnaire (total energy and macronutrient composition) will be completed. Every 3 months, appetite ratings, bioelectrical impedance (fat mass and fat-free mass), fasting venous bloods (glucose, insulin, gut hormones and systemic inflammation) and process evaluation (qualitative interviews) will be completed. Monthly monitoring will also include anthropometry and blood pressure. ETHICS AND DISSEMINATION: The study is conducted in accordance with the Declaration of Helsinki and has been approved by the Human Research Ethics Committee of the University of Cape Town (628/2021). Verbal and written consent is required from study participants. Results of this study will be published in peer-reviewed journals and presented at conferences. TRIAL REGISTRATION NUMBER: PACTR202302484999720.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6fca/11624751/de2e9d5307f4/bmjopen-14-12-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6fca/11624751/de2e9d5307f4/bmjopen-14-12-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6fca/11624751/de2e9d5307f4/bmjopen-14-12-g001.jpg

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[1]
Exploring the effects of ime-restricted ating on body weight and associated cardiometabolic outcomes in outh frican women living with HIV (TESSA): protocol for a randomised controlled trial.

BMJ Open. 2024-12-3

[2]
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本文引用的文献

[1]
Development and feasibility testing of a time-restricted eating intervention for women living with overweight/obesity and HIV in a resource-limited setting of South Africa.

BMC Public Health. 2024-10-10

[2]
Effects of 3 months of 10-h per-day time-restricted eating and 3 months of follow-up on bodyweight and cardiometabolic health in Danish individuals at high risk of type 2 diabetes: the RESET single-centre, parallel, superiority, open-label, randomised controlled trial.

Lancet Healthy Longev. 2024-5

[3]
Efficacy of different 8 h time-restricted eating schedules on visceral adipose tissue and cardiometabolic health: A study protocol.

Nutr Metab Cardiovasc Dis. 2024-1

[4]
Time-Restricted Eating Without Calorie Counting for Weight Loss in a Racially Diverse Population : A Randomized Controlled Trial.

Ann Intern Med. 2023-7

[5]
Designing a Co-created Intervention to Promote Motivation and Maintenance of Time-Restricted Eating in Individuals With Overweight and Type 2 Diabetes.

J Nutr Educ Behav. 2023-5

[6]
Comparison of the effects of six-week time-restricted eating on weight loss, body composition, and visceral fat in overweight older men and women.

Exp Gerontol. 2023-4

[7]
Weight and Metabolic Changes After Switching From Tenofovir Alafenamide/Emtricitabine (FTC)+Dolutegravir (DTG), Tenofovir Disoproxil Fumarate (TDF)/FTC + DTG, and TDF/FTC/Efavirenz to TDF/Lamivudine/DTG.

Clin Infect Dis. 2023-4-17

[8]
Association of Longitudinal Nutrient Patterns with Body Composition in Black Middle-Aged South African Women: A Five-Year Follow-Up Study.

Int J Environ Res Public Health. 2022-10-6

[9]
Pathophysiology of type 2 diabetes in sub-Saharan Africans.

Diabetologia. 2022-12

[10]
Effectiveness of a complex, pre-conception intervention to reduce the risk of diabetes by reducing adiposity in young adults in Malaysia: The Jom Mama project - A randomised controlled trial.

J Glob Health. 2022-8-17

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