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

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

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

Study Overview

• Status: Recruiting
• Conditions: Obesity; Infertility, Female
• Intervention / Treatment: Other: Healthy Lifestyle

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 Type: Interventional
• Enrollment (Estimated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: GEMMA BIVIÁ ROIG, PhD; Phone Number: 64339 961369000; Email: gemma.bivia@uchceu.es
• Study Contact Backup: Name: JUAN FRANCISCO L PÁRRAGA; Phone Number: 618055092; Email: juanfran@uchceu.es

Study Locations

• Spain
  • Castellón
    • Castellón De La Plana, Castellón, Spain
      • Recruiting
      • Hospital La Plana de Villarreal
      • Contact: JUAN FRANCISCO L PÁRRAGA; Phone Number: 618055092; Email: juanfran@uchceu.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental 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.	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.
No Intervention: Control Group; 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?

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

Collaborators and Investigators

• Sponsor: Cardenal Herrera University
• Collaborators: Hospital Universitario de la Plana
• Investigators: Principal Investigator: JUAN FRANCISCO L PÁRRAGA, PhD, Cardenal Herrera University

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2020
• Primary Completion (Estimated): April 15, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; obesity; nutrition; infertility; internet
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Infertility; Overweight; Infertility, Female
• Other Study ID Numbers: UNIVERSITY CARDENAL HERRERA-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No