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

Cardenal Herrera University

Status: Withdrawn

Conditions: Obesity; Infertility, Female

Treatments: Other: Healthy Lifestyle

Study type: Interventional

Funder types: Other

Identifiers

NCT04275869

UNIVERSITY CARDENAL HERRERA-25

Details and patient eligibility

About

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

Full 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)

Sex: Female

Ages: 18 to 40 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Experimental Healthy Lifestyle

Experimental group

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.

Treatment:

Other: Healthy Lifestyle

Control Group

No Intervention group

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.