Evidence mapPaperPMID 39627134Full record

ArticleBMJ open2024

Exploring the effects of

Amy E Mendham, Julia H Goedecke, Lorena Heckens, Fatima Hoosen, Majken Lillholm Pico, Andre P Kengne, Dirk L Christensen, Ole F Olesen, Jonas Salling Quist, Joel Dave and 2 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Amy E MendhamRiverland Academy of Clinical Excellence, Riverland Mallee Coorong Local Health Network, Berri, South Australia, Australia amy.mendham@sa.gov.au.ORCID http://orcid.org/0000-0002-1959-6698
Julia H GoedeckeHealth 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.ORCID http://orcid.org/0000-0001-6795-4771
Lorena HeckensHealth 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.ORCID http://orcid.org/0009-0009-1195-9632
Fatima HoosenHealth 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.
Majken Lillholm PicoCopenhagen University Hospital, Steno Diabetes Center Copenhagen, Herlev, Denmark.ORCID http://orcid.org/0000-0003-1272-6899
Andre P KengneNon-Communicable Disease Research Unit, South African Medical Research Council, Cape Town, South Africa.
Dirk L ChristensenGlobal Health Section, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.ORCID http://orcid.org/0000-0003-2142-522X
Ole F OlesenGlobal Health Section, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
Jonas Salling QuistCopenhagen University Hospital, Steno Diabetes Center Copenhagen, Herlev, Denmark.ORCID http://orcid.org/0009-0000-1618-9221
Joel Dave9Division of Endocrinology, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.
Kristine FærchCopenhagen University Hospital, Steno Diabetes Center Copenhagen, Herlev, Denmark.
Louise Groth GrunnetCopenhagen University Hospital, Steno Diabetes Center Copenhagen, Herlev, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWe 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.

Indexed as

Body WeightHIV InfectionsAdultCardiometabolic Risk FactorsFastingFemaleHumansMiddle AgedObesityOverweightRandomized Controlled Trials as TopicSouth AfricaYoung AdultDiabetes & endocrinologyNUTRITION & DIETETICSObesity

Identifiers

PMID39627134
PMCPMC11624751

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.