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

NCT ID: NCT04275869

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-27

Study Completion Date

2024-04-30

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)

Conditions

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Obesity Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Healthy Lifestyle

Intervention Type OTHER

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario de la Plana

OTHER

Sponsor Role collaborator

Cardenal Herrera University

OTHER

Sponsor Role lead

Responsible Party

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Juan F. Lisón Párraga, Dr

Head of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JUAN FRANCISCO L PÁRRAGA, PhD

Role: PRINCIPAL_INVESTIGATOR

Cardenal Herrera University

Locations

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Hospital La Plana de Villarreal

Castellon, Castellón, Spain

Site Status

Countries

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Spain

Other Identifiers

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UNIVERSITY CARDENAL HERRERA-25

Identifier Type: -

Identifier Source: org_study_id

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