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Lifestyle


- candidate number4364
- NTR NumberNTR1530
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-nov-2008
- Secondary IDsZonMW  50-50110-96-518
- Public TitleLifestyle
- Scientific TitleCosts and effects of a structured lifestyle program in overweight and obese subfertile couples to prevent unnecessary treatment and improve reproductive outcome
- ACRONYMLifestyle
- hypothesisIn view of this lack of evidence and strong practice variation we propose a randomized clinical trial in overweight and obese subfertile women, in which we compare the costs and effects of a six months structured lifestyle program, aimed at weight loss, to “usual care”. The intervention aims to prevent unnecessary fertility treatment, complications associated with fertility treatment and obesity related pregnancy complications, thus improving pregnancy chances and perinatal outcome.
- Healt Condition(s) or Problem(s) studiedOverweight, Infertility, Pregnancy, Obesity, Life style, Weight
- Inclusion criteria1. Subfertile women (age 18-38) with a BMI between 29 and 40
- Exclusion criteria1. Are azoospermia
2. Severe endometriosis
3. Chronic anovulation due to WHO III
4. Endocrinopathies.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2009
- planned closingdate31-dec-2013
- Target number of participants570
- InterventionsThe intervention consists of a structured lifestyle program of six months, which aims a realistic weight loss of at least 5% to10%, achieved by the combination of a healthy diet (caloric reduction of 600kCal/day), increase of physical activity (aiming at 10.000 steps per day) and two to three times a week sporting activity, and behavioural modification.
The structured lifestyle program, in which practice variation is minimized using a structured software program, has been developed, used and evaluated previously (Zon-MW project 50-50110-98-078; the Groninger Overweight And Lifestyle study (GOAL)). Following six months of lifestyle intervention patients will start fertility treatment as indicated in the “usual care” group.In the “usual care” arm fertility treatment will be started if this is justified by the individual prognosis (guideline NVOG).
All randomised women will fill in questionnaires concerning:
diet, eating behaviour, physical activity and smoking: SF-36, FFQ, DEBQ, Squash list, at inclusion, and at 12 weeks, 6 months, 12 months and 24 months after randomisation.
- Primary outcome- Primary endpoint is the birth of a healthy singleton after vaginal delivery of at least 37 weeks gestation.
- Secondary outcome- Secondary outcome parameters are:
- number of fertility treatments (OI, IUI, IVF, ICSI)
- clinical and ongoing pregnancy rates
- perinatal outcome
- complications
- quality of life
- body weight
- waist circumference
- behaviour influencing weight, i.e.
- nutritional habits
- exercise pattern
- smoking habits
- blood pressure
- glucose/insulin ratio (HOMA)
- costs.
- TimepointsPreparation of the study, including the training of the nurses, will take three months.
Inclusion of the couples will take 24 months and the lifestyle intervention will take six months.
Follow up is continued for 24 months after randomisation.
Database cleaning and analysis of the study will take 6 months.
Duration of the study: 57 months
- Trial web sitehttp://www.studies-obgyn.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. A. Hoek
- CONTACT for SCIENTIFIC QUERIESDr. A. Hoek
- Sponsor/Initiator University Medical Center Groningen (UMCG), Department of Obstetrics and Gynaecology
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryRationale:
Subfertility affects approximately one in ten couples planning conception. Among subfertile women, about 30% are overweight or even obese. Epidemiological data suggest that the reduction of overweight will increase the chances of conception, decrease pregnancy complications and improve perinatal outcome. In small intervention studies beneficial reproductive effects of improvement of lifestyle leading to a reduction in body weight have been demonstrated. The British Fertility Society advises that fertility treatment be withheld if the body mass index (BMI) is over 35. In the Netherlands, there is at present no agreed standard of care for subfertile women with overweight or obesity. Some centres simply withhold treatment of couples in whom the woman is overweight or obese, but most fertility centres treat overweight or obese women irrespective of their BMI. In a few centres, support is offered to women to help them lose weight.

Objective:
In view of this lack of evidence and strong practice variation we propose a randomized clinical trial in overweight and obese subfertile women, in which we compare the costs and effects of a six months structured lifestyle program, aimed at weight loss, to “usual care”. The intervention aims to prevent unnecessary fertility treatment, complications associated with fertility treatment and obesity related pregnancy complications, thus improving pregnancy chances and perinatal outcome.

Study design:
Multicenter randomised clinical trial.

Study population:
Subfertile women (age 18-38) with a BMI between 29 and 40. Exclusion criteria are azoospermia, severe endometriosis, chronic anovulation due to WHO III and endocrinopathies.

Intervention:
The intervention consists of a structured lifestyle program of six months, which aims a realistic weight loss of at least 5% to10%, achieved by the combination of a healthy diet (caloric reduction of 600kCal/day), increase of physical activity (aiming at 10.000 steps per day) and two to three times a week sporting activity, and behavioural modification. The structured lifestyle program, in which practice variation is minimized using a structured software program, has been developed, used and evaluated previously (Zon-MW project 50-50110-98-078; the Groninger Overweight And Lifestyle study (GOAL)). Following six months of lifestyle intervention patients will start fertility treatment as indicated in the “usual care” group.
In the “usual care” arm fertility treatment will be started if this is justified by the individual prognosis (guideline NVOG) All randomised women will fill in questionnaires concerning: diet, eating behaviour, physical activity and smoking: SF-36, FFQ, DEBQ, Squash list, at inclusion, and at 12 weeks, 6 months, 12 months and 24 months after randomisation.

Main study parameters/endpoints:
Primary endpoint is the birth of a healthy singleton after vaginal delivery of at least 37 weeks gestation.
Secondary outcome parameters are number of fertility treatments (OI, IUI, IVF, ICSI) , clinical and ongoing pregnancy rates, perinatal outcome, complications and quality of life as well as body weight, waist circumference, behaviour influencing weight, i.e. nutritional habits and exercise pattern, smoking habits, blood pressure, glucose/insulin ratio (HOMA), and costs.

DATA ANALYSIS:
Analysis will be by intention to treat. Randomisation will be stratified for age (<36 and > 36 years), and for the presence or absence of anovulation. We expect an improvement in vaginal singleton delivery beyond 37 weeks from 45% to 60%. Anticipating drop out of 20% in the intervention arm ad a 5% loss to follow up in the study, we need to include two groups of 285 women (two-sided test, alpha error.05, beta-error .20).

STUDY DURATION:
Preparation of the study, including the training of the nurses, will take three months. Inclusion of the couples will take 24 months and the lifestyle intervention will take six months. Follow up is continued for 24 months after randomisation. Database cleaning and analysis of the study will take 6 months. Duration of the study: 57 months

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The advantages of a weight loss and exercise program in overweight or obese subfertile women have been shown in small intervention studies. Even if the patient does not conceive during the 6 months period in the lifestyle intervention arm, the health benefits of weight loss on the long-term are clearly in the interest of the patient.
By starting this project, fertility treatment in the intervention arm will be delayed for a maximum of 6 months, there is no evidence that this delay will cause lower spontaneous or treatment dependent pregnancy chances. A more structured weight loss and exercise program will probably lead to higher spontaneous and therapy induced ongoing pregnancy chances.
The Burden: Patients that are randomized in the intervention arm will attend the clinic for six extra visits in order to improve lifestyle, this will take around 280 minutes. In between visits counselling will take place per telephone or mail four times dor 15 minutes. During these visits physical examination, measuring weight, WC and WHR in week: one, three, seven, twelve, eighteen and twenty-four will take place. Patients in the intervention group will have to adapt there lifestyle towards a more healthy lifestyle, this will give a certain amount of stress since they will have to adapt their diet and physical activity. Patients will be learned how to use stepcounter PAM and wear it on a daily basis in order to monitor their physical activity during the intervention period and will fill in their activity list.

Patients that randomize in the “usual care” group will undergo fertility treatment when indicated by national guidelines (www.nvog.nl). Doctors responsible for the fertility treatment may refuse to start treatment when the body weight of the patient is too high and complications are anticipated. Patients will than be advised to reduce their body weight before starting treatment.

Questionnaires will be to be filled in by all participants in the study: SF-36, SQUASH-list, FFQ, DEBQ, concerning eating behaviour at the start, week twelve, twenty-four and fifty-two of the study. A questionnaire for details on direct and indirect costs like transportation, sporting activity and productivity loss due to lifestyle intervention programme and fertility treatment will be filled in by the participants during the study. This will take 30-45 minutes.
- Main changes (audit trail)
- RECORD16-nov-2008 - 3-mrt-2009


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