search
Back to results

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

Primary Purpose

Obesity, Infertility, Female

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Healthy Lifestyle
Sponsored by
Cardenal Herrera University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring infertility, obesity, physical activity, nutrition, internet

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Hospital La Plana de VillarrealRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Healthy Lifestyle

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Body mass index (BMI)
Weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2.
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.
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.
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).

Full Information

First Posted
February 17, 2020
Last Updated
July 28, 2023
Sponsor
Cardenal Herrera University
Collaborators
Hospital Universitario de la Plana
search

1. Study Identification

Unique Protocol Identification Number
NCT04275869
Brief Title
Internet-based Intervention to Promote a Healthy Lifestyle on the Reproductive Parameters of Overweight and Obese Women
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2020 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University
Collaborators
Hospital Universitario de la Plana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Infertility, Female
Keywords
infertility, obesity, physical activity, nutrition, internet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Healthy Lifestyle
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Healthy Lifestyle
Intervention Description
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 Measure Information:
Title
Spontaneous clinical pregnancy rate
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Body mass index (BMI)
Description
Weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2.
Time Frame
12 months
Title
Abdominal perimeter
Description
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.
Time Frame
12 months
Title
Mediterranean Diet Adherence
Description
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.
Time Frame
12 months
Title
Physical activity level
Description
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).
Time Frame
12 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
GEMMA BIVIÁ ROIG, PhD
Phone
961369000
Ext
64339
Email
gemma.bivia@uchceu.es
First Name & Middle Initial & Last Name or Official Title & Degree
JUAN FRANCISCO L PÁRRAGA
Phone
618055092
Email
juanfran@uchceu.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JUAN FRANCISCO L PÁRRAGA, PhD
Organizational Affiliation
Cardenal Herrera University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital La Plana de Villarreal
City
Castellón De La Plana
State/Province
Castellón
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JUAN FRANCISCO L PÁRRAGA
Phone
618055092
Email
juanfran@uchceu.es

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs