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

Sponsor

Université de Sherbrooke (Other)

Overall Status

Completed

CT.gov ID

NCT01483612

Collaborator

Canadian Institutes of Health Research (CIHR) (Other), Ministere de la Sante et des Services Sociaux (Other)

130

Enrollment

Location

Arms

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Female Infertility Polycystic Ovary Syndrome Obesity	Behavioral: Interdisciplinary lifestyle intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

"Evaluation of Clinical Outcomes and Costs of a Transferable Interdisciplinary Lifestyle Intervention Pre- and Per-pregnancy in Obese Infertile Women"

Actual Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Aug 1, 2018

Actual Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lifestyle counseling	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 Names: Lifestyle program for obese infertile women
No Intervention: control

Arm

Intervention/Treatment

Experimental: Lifestyle counseling

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 Names:

Lifestyle program for obese infertile women

No Intervention: control

Outcome Measures

Primary Outcome Measures

Rates of live birth [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]

Secondary Outcome Measures

Fertility outcomes [18 months]
Pregnancy outcomes [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 [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 [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 [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 [18 months]
Evolution of anthropometric measures and change in lifestyle habits in male partners.
Clinical outcomes of female participants [18 months]
Evolution of anthropometric measures, changes in lifestyle habits (diet, exercise, alcohol, tobacco), physical fitness level, evolution of readiness for change, etc.