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Evaluation of Clinical Outcomes and Costs of a Lifestyle Intervention in Obese Infertile Women (OF)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01483612
First Posted: December 1, 2011
Last Update Posted: October 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Canadian Institutes of Health Research (CIHR)
Ministere de la Sante et des Services Sociaux
Information provided by (Responsible Party):
Jean-Patrice Baillargeon, Université de Sherbrooke
November 25, 2011
December 1, 2011
October 25, 2016
November 2011
April 2018   (Final data collection date for primary outcome measure)
Rates of live birth [ Time Frame: Participants who will become pregnant: for the duration before they get pregnant and up to the end of pregnancy, an expected average of 18 months. Participants who will not become pregnant: 18 months ]
Same as current
Complete list of historical versions of study NCT01483612 on ClinicalTrials.gov Archive Site
  • Fertility outcomes [ Time Frame: 18 months ]
  • Pregnancy outcomes [ Time Frame: Participants who will become pregnant: up to the end of pregnancy, an expected average of 18 months of follow-up in the study ]
  • Neonatal outcomes [ Time Frame: Participants who will become pregnant: up to the end of pregnancy, an expected average of 18 months of follow-up in the study ]
  • Clinical outcomes [ Time Frame: 18 months ]
    Evolution of anthropometric measures, change in lifestyle habits, physical fitness level and evolution of readiness for change.
  • Cost per life birth, and other measures of cost-effectiveness [ Time Frame: Participants who will become pregnant: for the duration before they get pregnant and up to the end of pregnancy, an expected average of 18 months. Participants who will not become pregnant: 18 months ]
    All costs (interventions and complications) to achieve one life birth, including either all women with a life birth or all enrolled women (by intervention arm).
  • Clinical outcomes in male partners [ Time Frame: 18 months ]
    Evolution of anthropometric measures and change in lifestyle habits in male partners.
  • Clinical outcomes of female participants [ Time Frame: 18 months ]
    Evolution of anthropometric measures, changes in lifestyle habits (diet, exercise, alcohol, tobacco), physical fitness level, evolution of readiness for change, etc.
Same as current
Not Provided
Not Provided
 
Evaluation of Clinical Outcomes and Costs of a Lifestyle Intervention in Obese Infertile Women
"Evaluation of Clinical Outcomes and Costs of a Transferable Interdisciplinary Lifestyle Intervention Pre- and Per-pregnancy in Obese Infertile Women"

BACKGROUND: Obesity increases the risk of polycystic ovary syndrome (PCOS), characterized by anovulatory cycles, but it is also associated with reduced fertility even in ovulatory women. Moreover, obesity increases the costs of assisted human reproduction (AHR) treatments and reduces their efficacy. In addition to fertility disorders, obesity increases significantly the risks of many complications of pregnancy, delivery and neonatal health. However, a modest loss of 5-10% of total body weight can restore ovulation and improve pregnancy rates.

OBJECTIVES: 1) To design and implement a multidisciplinary program for lifestyle management of obese women, or overweight women with PCOS, who seek fertility treatment in a secondary AHR center. 2) To evaluate lifestyle benefits of this program and assess its impact on fertility, pregnancy and neonatal outcomes, as compared to a randomly assigned control group and to similar women seen in tertiary AHR centers. 3) To assess cost per live birth, and other measures of cost-effectiveness, of this program compared to the control group and tertiary AHR centers. 4) To effectively transfer knowledge obtained through these activities to relevant stakeholders in the health care and public health sectors.

METHODS AND APPROACH: In order to design the program for lifestyle management of obesity in infertile women, we will gather a Committee composed of members of our interdisciplinary research team and relevant collaborators. Objectives 2 and 3 - In order to achieve these objectives, 128 obese women (BMI ≥ 30 kg/m²), or overweight women with PCOS (BMI ≥ 27 kg/m²), consulting at the CHUS fertility clinic will be randomized to our lifestyle program, and will suspend fertility treatments for six months, or to standard fertility treatments, which are directly initiated. The results obtained will also be compared to those of women with the same criteria who will consult in 3 tertiary AHR clinics not offering a similar lifestyle management program.

IMPACT: This project is very important as it will generate new knowledge about the implementation, impacts and costs of a new lifestyle management program in obese infertile women. Our project will obtain valuable data on implementability of such a program; on benefits with regard to lifestyle, fertility and maternal and foetal complications during pregnancy; as well as on reduction in cost per live birth and other cost-effectiveness ratio.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
  • Female Infertility
  • Polycystic Ovary Syndrome
  • Obesity
Behavioral: Interdisciplinary lifestyle intervention

Individual meetings with a dietitian and a kinesiologist at 0, 3, 6 weeks and then every 6 weeks for 18 months or until delivery. A reminder phone call/email will also take place once between each meeting.

The program also includes 12 group sessions discussing subjects about nutrition, psychology and demonstration of physical activity.

Other Name: Lifestyle program for obese infertile women
  • Experimental: Lifestyle counseling
    Intervention: Behavioral: Interdisciplinary lifestyle intervention
  • No Intervention: control
Duval K, Langlois MF, Carranza-Mamane B, Pesant MH, Hivert MF, Poder TG, Lavoie HB, Ainmelk Y, St-Cyr Tribble D, Laredo S, Greenblatt E, Sagle M, Waddell G, Belisle S, Riverin D, Jean-Denis F, Belan M, Baillargeon JP. The Obesity-Fertility Protocol: a randomized controlled trial assessing clinical outcomes and costs of a transferable interdisciplinary lifestyle intervention, before and during pregnancy, in obese infertile women. BMC Obes. 2015 Dec 1;2:47. doi: 10.1186/s40608-015-0077-x. eCollection 2015.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
130
April 2018
April 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Obese (BMI ≥ 30kg/m2) infertile women
  • Overweight (BMI ≥ 27kg/m2) infertile women with polycystic ovary syndrome

Exclusion Criteria:

  • Women older than 40 years old
  • Women who went through bariatric surgery
  • Women under IVF
  • Women for whome IVF is the only recommended treatment
  • Women who do not speak french
Sexes Eligible for Study: Female
18 Years to 40 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01483612
CIHR/FRN-114125
No
Not Provided
Not Provided
Jean-Patrice Baillargeon, Université de Sherbrooke
Université de Sherbrooke
  • Canadian Institutes of Health Research (CIHR)
  • Ministere de la Sante et des Services Sociaux
Principal Investigator: Jean-Patrice Baillargeon, MD Université de Sherbrooke
Université de Sherbrooke
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP