Internet-based Intervention to Promote a Healthy Lifestyle on the Reproductive Parameters of Overweight and Obese Women

Study Overview
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Brief Summary
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Obesity and overweight are among the problems that produce infertility. The combination of diet and exercise to achieve weight loss are currently considered an effective intervention for the improvement of reproductive parameters in overweight or obese infertile women. Aim: to evaluate the effectiveness of an online program to promote a healthy lifestyle among women who are overweight or obese who also have a diagnosis of infertility and are on the waiting list for in vitro fertilisation treatment

Detailed Description
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Weight management problems (being obese or overweight) are among the problems that produce infertility. The combination of diet and exercise to achieve weight loss are currently considered an effective intervention for the improvement of reproductive parameters in overweight or obese infertile women. Aim: to evaluate the effectiveness of a 3-month internet-based program focusing on the promotion of healthy lifestyles (especially weight loss and healthy eating and physical exercise habits) in women who also have a diagnosis of infertility and are on the waiting list for IVF treatment. Design: randomised controlled trial Setting: Hospital La Plana (Villarreal)

Official Title
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Efficacy of an Internet-based Intervention to Promote a Healthy Lifestyle on the Reproductive Parameters of Overweight and Obese Women: a Randomised Controlled Trial

Conditions
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Obesity, Infertility, Female

Intervention / Treatment
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* Other: Healthy Lifestyle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women of childbearing age overweight (BMI > 25 kg/m2) or obese (BMI > 30 kg/m2) diagnosed with primary infertility -access to the internet- Exclusion Criteria: over 40 years morbid or extreme obesity (BMI > 40 kg/m2) bilateral obstruction of the fallopian tubes endometriosis women whose partner has a severe male factor (oligoasthenoteratozoospermia).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Healthy Lifestyle<br>A 3-month internet-based program focusing on the promotion of healthy lifestyles. The treatment protocol comprises 9 modules which incorporate psychological strategies to promote healthy lifestyles by gradually changing eating and physical activity habits. | Other: Healthy Lifestyle<br>* A 3-month internet-based program focusing on the promotion of healthy lifestyles. The treatment protocol comprises 9 modules which incorporate psychological strategies to promote healthy lifestyles by gradually changing eating and physical activity habits.<br>|
| No Intervention: Control Group<br>Control group will receive the standard treatment which consists of regular gynaecological visits; the Reproduction Service gynaecologists will recommend healthy lifestyle habits and give the patients a document detailing a specific diet they should follow for weight loss. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous clinical pregnancy rate | The primary outcome will be the spontaneous clinical pregnancy rate (pregnancy with ultrasound visualisation of the gestational sac at week 7 of pregnancy) and evolution (pregnancy with ultrasound visualisation of the gestational sac and a heartbeat after 20 weeks of gestation). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index (BMI) | Weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2. | 12 months | 
| Abdominal perimeter | It will be measured with a tape-measure at the level of the navel (without compressing the skin tissue) and after drawing in air following one deep inhalation and exhalation. | 12 months | 
| Mediterranean Diet Adherence | Mediterranean Diet Adherence Screener (MEDAS) questionnaire used in the PREDIMED trial. This questionnaire has been validated for the Spanish population and assesses adherence to the Mediterranean diet. | 12 months | 
| Physical activity level | This is a self-administered questionnaire comprising 7 items which collects information about the physical activity the surveyee has completed in 7 days prior to completing the test. The IPAQ-SF will be used to calculate the total number of minutes and days the person has engaged in physical activity by adding all physical activity category scores from the prior 7 days together. This data will be converted into metabolic equivalent of task minutes per week (MET-min/week), using the formula published by Ainsworth et al., to classify their physical activity levels as 'high' (> 1,500 MET-min/week), 'moderate' (600-1,500 MET-min/week), or 'low' (< 600 MET-min/week). | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infertility, obesity, physical activity, nutrition, internet