Fit-for-Fertility Multicenter Randomized Controlled Trial

NAActive, not recruitingINTERVENTIONAL
Enrollment

408

Participants

Timeline

Start Date

April 3, 2019

Primary Completion Date

December 31, 2029

Study Completion Date

December 31, 2029

Conditions
ObesityInfertility, Female
Interventions
BEHAVIORAL

Fit-For-Fertility program

The Fit-for-Fertility Program aims at implementing progressive and sustainable lifestyle changes. Participants will attend individual sessions with a dietitian and a kinesiologist every 6 weeks for the first 6 months, then every 8 weeks for the 6 following months, and then every 12 weeks until end of the study. Follow-up by telephone/e-mail will be offered between in-person meetings. These professionals will be trained in motivational counselling skills. Participants will also benefit from weekly group sessions divided into 2 parts: 1) Workshops covering 8 different topics (45 minutes) addressing healthy lifestyle and 2) Supervised classes of physical activity where one of 8 different types of exercise (45 minutes) will be practiced. Women will be required to attend all 8 different sessions within the first 6 months. Pregnant women will be met to set new lifestyle objectives specific to pregnancy, including optimal gestational weight gain based on the Institute of Medicine guidelines.

OTHER

Standard of care

The control intervention will consist of immediate initiation of usual fertility care, as recommended by each fertility specialist, for a maximum of 24 months. The experimental intervention will be the Fit-for-Fertility Program alone for the first 6 months, then in combination with usual fertility care for an additional 12 months and thereafter, usual fertility care can continue to be provided alone for a maximum follow-up of 24 months. The lifestyle program is provided for a maximum of 18 months if there is no pregnancy, or otherwise, up to the end of pregnancy or to a total study follow-up of 24 months (whichever comes first).

Trial Locations (5)

Unknown

Olive Fertility Centre, Vancouver

Mount Sinai Hospital, Toronto

Centre hospitalier de l'Université de Montréal (CHUM), Montreal

Centre hospitalier de l'Université Laval, Québec

J1H 5N4

Centre hospitalier universitaire de Sherbrooke, Sherbrooke

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

OTHER

collaborator

Ferring Pharmaceuticals

INDUSTRY

lead

Université de Sherbrooke

OTHER