PRE-Pregnancy Weight Loss and the Reducing Effect on CHILDhood Overweight (PREPARE CHILD): clinical trial protocol for a randomised controlled trial
15 affiliations
- 1Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark
- 2Department of Gynecology and Obstetrics, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark
- 3Department of Clinical Medicine, University of Copenhagen, Copenhagen N, Denmark
- 4Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
- 5Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark
- 6Department of Biology, Laboratory of Integrative Biomedicine, University of Copenhagen, Copenhagen, Denmark
- 7Department of Endocrinology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark
- 8Department of Biomedicine, Aarhus University Hospital, Aarhus, Denmark
- 9Department of Infectious Diseases, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
- 10Gastro Unit, Copenhagen University Hospital Hvidovre, Copenhagen, Denmark
- 11Department of Pediatrics, University of California San Francisco, San Francisco, California, USA
- 12Departments of Pediatrics and Medicine, University of California San Francisco, San Francisco, California, USA
- 13Department of Growth and Reproduction, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
- 14Department of Cellular and Molecular Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
- 15Department of Obstetrics and Gynecology, Aarhus University Hospital, Aarhus, Denmark
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.
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BibTeX
@article{nygaard2026prepregnancy,
title = {{PRE-Pregnancy Weight Loss and the Reducing Effect on CHILDhood Overweight (PREPARE CHILD): clinical trial protocol for a randomised controlled trial}},
author = {Malene Nygaard and Kathrine Vauvert R Hviid and Louise Birk Suder and Faidon Magkos and Camilla T Damsgaard and Karsten Kristiansen and Sten Madsbad and Annette Vedelspang and Henrik Støvring and Lotte Lauritzen and Sophie Hilario Christensen and Lise Lotte Gluud and Janet M Wojcicki and Ronald M Krauss and Anni Larnkjaer and Henrik Munch Roager and Kristian Almstrup and Christian Mølgaard and Ulla Kampmann and Per Glud Ovesen and Henriette Svarre Nielsen and Nina Rica Wium Geiker},
journal = {BMJ Open},
year = {2026},
month = oct,
doi = {10.1136/bmjopen-2025-111652},
url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2025-111652},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - PRE-Pregnancy Weight Loss and the Reducing Effect on CHILDhood Overweight (PREPARE CHILD): clinical trial protocol for a randomised controlled trial
AU - Malene Nygaard
AU - Kathrine Vauvert R Hviid
AU - Louise Birk Suder
AU - Faidon Magkos
AU - Camilla T Damsgaard
AU - Karsten Kristiansen
AU - Sten Madsbad
AU - Annette Vedelspang
AU - Henrik Støvring
AU - Lotte Lauritzen
AU - Sophie Hilario Christensen
AU - Lise Lotte Gluud
AU - Janet M Wojcicki
AU - Ronald M Krauss
AU - Anni Larnkjaer
AU - Henrik Munch Roager
AU - Kristian Almstrup
AU - Christian Mølgaard
AU - Ulla Kampmann
AU - Per Glud Ovesen
AU - Henriette Svarre Nielsen
AU - Nina Rica Wium Geiker
PY - 2026
DA - 2026/10/30
JO - BMJ Open
DO - 10.1136/bmjopen-2025-111652
UR - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2025-111652
AB - 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.
SN - 2044-6055
SN - 2044-6055
ER -