{ "abstract": "Introduction Parental obesity is associated with childhood obesity. Maternal overweight/obesity before pregnancy increases the risk of pregnancy complications and offspring born large for gestational age as well as increased risk of developing obesity in childhood. Moreover, the relationship between paternal characteristics and offspring health is sparsely investigated. Lifestyle interventions among pregnant women have been shown to improve maternal outcomes but have shown no differences in offspring outcomes. Therefore, this trial aims to investigate the effect of pre-pregnancy diet-induced weight loss among prospective mothers with overweight/obesity and fathers on neonatal adiposity at birth.Methods and analysis This randomised controlled trial examines the effect of weight loss induced prior to pregnancy by a very-low calorie diet (intervention) for 8–10 weeks compared with no treatment (control) on offspring fat mass at birth. Prospective mothers with overweight/obesity with or without their partners will be randomised in a 1:1 ratio to either the intervention or control group. Females with overweight/obesity (body mass index of 27.0–44.9 kg/m2), 18–38 years of age, who plan a pregnancy within the following year (prospective mothers) are recruited. Biological prospective fathers who agree to participate with their female partner are also included. Participants are followed with examinations before, during, and after pregnancy until the offspring is 12 months of age. Thereafter, annual phone calls will be conducted to collect information on the offspring’s height and weight until the age of 14 years. The primary outcome is neonatal fat mass assessed by air displacement plethysmography (PEA POD) at birth.Ethics and dissemination The trial is approved by the Regional Committee on Health Research Ethics of the Capital Region, Copenhagen, Denmark(H-22026590) and by the Danish Data Protection Agency (Capital Region: P-2022-706; University of Copenhagen: 514–0363/22-5000) and is registered at ClinicalTrials.gov (NCT05621109). The trial is conducted in accordance with the Declaration of Helsinki. After completion and analysis of the trial, the results will be published in an international peer-reviewed journal, irrespective of positive, negative or inconclusive findings.Trial registration number NCT05621109.Protocol version First approved protocol version F1.4 approved 12 November 2022. This paper describes protocol version F1.11 approved 02 December 2025.", "abstract_shown": true, "affiliations": [ "Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark", "Department of Gynecology and Obstetrics, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark", "Department of Clinical Medicine, University of Copenhagen, Copenhagen N, Denmark", "Department of Clinical Medicine, Aarhus University, Aarhus, Denmark", "Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark", "Department of Biology, Laboratory of Integrative Biomedicine, University of Copenhagen, Copenhagen, Denmark", "Department of Endocrinology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark", "Department of Biomedicine, Aarhus University Hospital, Aarhus, Denmark", "Department of Infectious Diseases, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark", "Gastro Unit, Copenhagen University Hospital Hvidovre, Copenhagen, Denmark", "Department of Pediatrics, University of California San Francisco, San Francisco, California, USA", "Departments of Pediatrics and Medicine, University of California San Francisco, San Francisco, California, USA", "Department of Growth and Reproduction, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark", "Department of Cellular and Molecular Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark", "Department of Obstetrics and Gynecology, Aarhus University Hospital, Aarhus, Denmark" ], "article_type": "research article", "arxiv": null, "author_total": 22, "authors": [ { "affs": [ 0 ], "name": "Malene Nygaard", "orcid": "0000-0003-4905-1450" }, { "affs": [ 1, 2 ], "name": "Kathrine Vauvert R Hviid", "orcid": "0000-0002-1172-6099" }, { "affs": [ 3, 4 ], "name": "Louise Birk Suder" }, { "affs": [ 0 ], "name": "Faidon Magkos" }, { "affs": [ 0 ], "name": "Camilla T Damsgaard", "orcid": "0000-0002-5013-0562" }, { "affs": [ 5 ], "name": "Karsten Kristiansen" }, { "affs": [ 2, 6 ], "name": "Sten Madsbad" }, { "affs": [ 0 ], "name": "Annette Vedelspang" }, { "affs": [ 4, 7 ], "name": "Henrik Støvring" }, { "affs": [ 0 ], "name": "Lotte Lauritzen", "orcid": "0000-0001-7184-5949" }, { "affs": [ 0, 8 ], "name": "Sophie Hilario Christensen", "orcid": "0000-0001-9592-0376" }, { "affs": [ 2, 9 ], "name": "Lise Lotte Gluud", "orcid": "0000-0002-9462-4468" }, { "affs": [ 10 ], "name": "Janet M Wojcicki" }, { "affs": [ 11 ], "name": "Ronald M Krauss" }, { "affs": [ 0 ], "name": "Anni Larnkjaer" }, { "affs": [ 0 ], "name": "Henrik Munch Roager", "orcid": "0000-0002-2504-8313" }, { "affs": [ 12, 13 ], "name": "Kristian Almstrup" }, { "affs": [ 0 ], "name": "Christian Mølgaard" }, { "affs": [ 3, 4 ], "name": "Ulla Kampmann" }, { "affs": [ 3, 4, 14 ], "name": "Per Glud Ovesen" }, { "affs": [ 1, 2 ], "name": "Henriette Svarre Nielsen" }, { "affs": [ 0 ], "name": "Nina Rica Wium Geiker", "orcid": "0000-0001-8063-5820" } ], "bibtex": "https://research.draconitic.com/paper/2g5cd1y51hekf.bib", "cited_by": 0, "doi": "10.1136/bmjopen-2025-111652", "fulltext_url": "https://bmjopen.bmj.com/content/16/10/e111652.full", "id": "2g5cd1y51hekf", "issns": [ "2044-6055", "2044-6055" ], "landing_url": "https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2025-111652", "language": "en", "licence": "CC-BY-NC-4.0", "licence_label": "CC BY-NC 4.0", "licence_source": "article", "licence_url": "https://creativecommons.org/licenses/by-nc/4.0/", "metadata_licence": null, "native_subjects": [ [ "heading", "1506" ], [ "heading", "1714" ], [ "heading", "Nutrition and Metabolism" ], [ "heading", "Protocol" ], [ "lcc", "R" ] ], "openalex": null, "pdf_url": null, "pmcid": "PMC13723812", "pmid": "42963093", "published": "2026-10-30", "publisher": "BMJ", "ris": "https://research.draconitic.com/paper/2g5cd1y51hekf.ris", "sources": [ { "first_seen": "2026-10-31T00:21:03Z", "native_id": "10.1136/bmjopen-2025-111652", "source": "crossref", "url": "https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2025-111652" }, { "first_seen": "2026-10-31T14:22:55Z", "native_id": "29fd72db2d00425a9aff985c717133bf", "source": "doaj", "url": "https://doi.org/10.1136/bmjopen-2025-111652" }, { "first_seen": "2026-11-04T12:22:22Z", "native_id": "PMC13723812", "source": "pmc", "url": "https://doi.org/10.1136/bmjopen-2025-111652" } ], "subjects": [ { "field": "medicine", "origin": "lcc:R", "subfield": "general" } ], "title": "PRE-Pregnancy Weight Loss and the Reducing Effect on CHILDhood Overweight (PREPARE CHILD): clinical trial protocol for a randomised controlled trial", "title_text": "PRE-Pregnancy Weight Loss and the Reducing Effect on CHILDhood Overweight (PREPARE CHILD): clinical trial protocol for a randomised controlled trial", "type": "peer-reviewed", "updated_at": "2026-11-05T12:20:33Z", "url": "https://research.draconitic.com/paper/2g5cd1y51hekf", "venue": "BMJ Open", "versions": [] }