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

Not Applicable

Withdrawn

• Conditions: Infertility, Female; Obesity
• Interventions: Other: Healthy Lifestyle

• Registration Number: NCT04275869
• Lead Sponsor: Cardenal Herrera University

Brief Summary

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

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)

Study Timeline

• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-19
• Study Start: 2020-02-27
• Primary Completion: 2024-04-15
• Study Completion: 2024-04-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: 94

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Healthy Lifestyle	Healthy Lifestyle	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.

Primary Outcome Measures

Name	Time	Method
Spontaneous clinical pregnancy rate	12 months	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).

Secondary Outcome Measures

Name	Time	Method
Body mass index (BMI)	12 months	Weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m\^2.
Physical activity level	12 months	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).
Abdominal perimeter	12 months	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.
Mediterranean Diet Adherence	12 months	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.

Trial Locations

Locations (1)

Hospital La Plana de Villarreal; 🇪🇸 Castellón De La Plana, Castellón, Spain