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

Obesity Clinical Trial

— HLRP-RCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04275869
• Other study ID #: UNIVERSITY CARDENAL HERRERA-25
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2020
• Est. completion date: April 30, 2024

Study information

• Verified date: July 2023
• Source: Cardenal Herrera University
• Contact: GEMMA BIVIÁ ROIG, PhD
• Phone: 961369000
• Email: gemma.bivia[@]uchceu.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: April 30, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Obesity
• Overweight

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	Hospital La Plana de Villarreal	Castellón De La Plana	Castellón

Sponsors (2)

Lead Sponsor	Collaborator
Cardenal Herrera University	Hospital Universitario de la Plana

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Body mass index (BMI)	Weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2.	12 months
Secondary	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
Secondary	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
Secondary	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