Protocol of the Fit-For-Fertility study: a multicentre randomised controlled trial assessing a lifestyle programme targeting women with obesity and infertility.
Diabetes & endocrinology
Health economics
Protocols & guidelines
Reproductive medicine
Subfertility
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
19 04 2022
19 04 2022
Historique:
entrez:
20
4
2022
pubmed:
21
4
2022
medline:
22
4
2022
Statut:
epublish
Résumé
Women with obesity are at a higher risk of infertility as well as gestational and neonatal complications. Lifestyle changes are universally recommended for women with obesity seeking fertility treatments, but such intervention has only been assessed in very few robust studies. This study's objectives are therefore to assess the clinical outcomes and cost-effectiveness of an interdisciplinary lifestyle intervention (the Fit-For-Fertility Programme; FFFP) targeting women with obesity and subfertility in a diverse population. This pragmatic multicentre randomised controlled trial (RCT) will include 616 women with obesity (body mass index ≥30 kg/m This research study has been approved by the Research Ethics Board (REB) of NCT03908099. 1.1, 13 April 2019.
Identifiants
pubmed: 35440463
pii: bmjopen-2022-061554
doi: 10.1136/bmjopen-2022-061554
pmc: PMC9020282
doi:
Banques de données
ClinicalTrials.gov
['NCT03908099']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e061554Investigateurs
R Bouzayen
(R)
N Chaillet
(N)
W Fraser
(W)
F Gallagher
(F)
A Godbout
(A)
E Greenblatt
(E)
C Kamga-Ngande
(C)
Kong Weilin
(K)
S Laredo
(S)
M Sagle
(M)
B Taylor
(B)
Informations de copyright
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: Ferring has provided an unrestricted grant for the trial, without influencing the design or conduct of the trial, or the analysis or dissemination of the study’s results.
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