Evaluation of a Mobile Preconception Lifestyle Programme in Couples Undergoing In Vitro Fertilisation

NCT03790449 | Terminated

• 1 other identifier: s61596
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 5

Brief Summary

The aim of the PreLiFe RCT is to assess the effects of a new mobile preconception lifestyle programme (PreLiFE-programme) for couples undergoing IVF. Couples about to start IVF will be randomized between an attention control programme or the PreLiFe-programme for 12 months or until an ongoing pregnancy is confirmed by ultrasound.This study will examine whether the PreLiFe-programme results in a higher cumulative ongoing pregnancy rate within 12 months as compared to an attention control programme. Secondary outcomes include changes in diet, physical activity, personal wellbeing, body mass index, waist circumference, quality of life and other reproductive outcomes including clinical pregnancy and time to pregnancy. Additionally, the partners' support and the feasibility of the PreLiFe-programme will be evaluated.

Conditions

Infertility

Keywords

Infertility; Lifestyle; mobile health; Diet; Physical Activity; Mindfulness

Outcome Measures

Primary Outcomes (1)

• Cumulative ongoing pregnancy rate (COPR) within 12 months after randomisation

  Ongoing pregnancy is defined as a viable intrauterine pregnancy of at least 12 weeks duration confirmed on ultrasound scan. All pregnancies (Spontaneous and IVF pregnancies) conceived within these 12 months are followed up until the 12 weeks ultrasound scan. IVF-discontinuation is described as couples undergoing IVF who do not return for a further IVF cycle in our fertility centres after the failure of a previous cycle. Ongoing pregnancy within 12 months after randomisation is counted as a positive event, whereas IVF discontinuation and absence of pregnancy are counted as a negative event. Differences in COPR will be evaluated between the intervention and attention control group.

  12 months

Secondary Outcomes (8)

• Changes in diet assessed with a Food Frequency Questionnaire (FFQ)

  at baseline, 3 months, 6 months, 9 months and 12 months after randomisation

• Changes in physical activity assessed with the International Physical Activity Questionnaire (IPAQ)

  at baseline, 3 months, 6 months, 9 months and 12 months after randomisation

• Changes in symptoms of emotional distress, anxiety and depression (personal wellbeing) assessed with the Depression, anxiety and stress scale (DASS-21)

  at baseline, 3 months, 6 months, 9 months and 12 months after randomisation

• Changes in fertility related quality of life assessed with the Fertility Quality of Life Tool (FERTIQOL).

  at baseline, 3 months, 6 months, 9 months and 12 months after randomisation

• Changes in Body Mass Index (BMI)

  at baseline, 3 months, 6 months, 9 months and 12 months after randomisation

Other Outcomes (4)

• Use of the PreLiFe-programme assessed with app based tracking

  at 3 months, 6 months, 9 months and 12 months after randomisation

• Acceptability of the PreLiFe-programme assessed with a subscale of the Mobile App Rating Scale (MARS)

  12 months

• Partners' support assessed with a questionnaire

  at 3 months, 6 months, 9 months and 12 months after randomisation

Study Arms (2)

PreLiFe-programme

EXPERIMENTAL

A Mobile Preconception Lifestyle programme

Behavioral: PreLiFe-programme; Behavioral: Attention Control Programme

Attention Control

OTHER

Attention Control Programme

Behavioral: Attention Control Programme

Interventions

PreLiFe-programme BEHAVIORAL

The intervention group will receive a mobile preconception lifestyle programme (the PreLiFe-programme) in addition to standard care for 12 months or until an ongoing pregnancy is confirmed by ultrasound. The PreLiFe-programme includes a mobile application (PreLiFe-app) with the same treatment information as the attention control group in combination with a lifestyle programme. This new lifestyle programme includes tailored advice and skills training on diet and physical activity and mindfulness exercises. Additionally couples will be offered interaction with a health care provider through text messages and telephone interaction following the concept of blended care.

PreLiFe-programme

Attention Control Programme BEHAVIORAL

The standard care serving as control for this intervention is fertility treatment i.e. IVF with or without ICSI according to local protocols for infertility patients. This implies no guidance on lifestyle. However, to have attention control the control group will receive an attention control programme. The attention control programme includes a mobile application (app) with treatment information including medication instructions, reminders of injection of human Chorionic Gonadotropin (hCG) and time of fertility treatment appointments for 12 months or until an ongoing pregnancy is confirmed by ultrasound.

Attention Control; PreLiFe-programme

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Infertile heterosexual couples about to start a first IVF-cycle (with or without ICSI) with infertility defined as the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse
• Women of couples aged ≤ 38 years
• Both partners possess a smartphone
• Both partners understand and speak Dutch
• Written informed consent after been informed on all aspects of the study

You may not qualify if:

• Couples with previous IVF/ICSI treatment cycles
• Couples where one of the partners has special dietary requirements including but not limited to patients that underwent bariatric surgery, patients with coeliac disease or renal disease
• Couples where one of the partners has specific movement's constraints including but not limited to patients with cerebral palsy or hemiparesis
• Couples starting IVF/ICSI with preimplantation genetic diagnosis (PGD)
• Couples using donor gametes or donor embryos

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Research Foundation Flanders: collaborator
• KU Leuven: collaborator
• University Hospital, Antwerp: collaborator

Study Sites (5)

University Hospital Antwerp

Antwerp, 2000, Belgium

Location

Imelda Hospital Bonheiden

Bonheiden, 2820, Belgium

Location

Academic Hospital Sint Jan Bruges-Ostend

Bruges, 8000, Belgium

Location

Academic Hospital Diest

Diest, 3290, Belgium

Location

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Related Publications (3)

• Boedt T, Dancet E, De Neubourg D, Vereeck S, Jan S, Van der Gucht K, Van Calster B, Spiessens C, Lie Fong S, Matthys C. A blended preconception lifestyle programme for couples undergoing IVF: lessons learned from a multicentre randomized controlled trial. Hum Reprod Open. 2023 Sep 29;2023(4):hoad036. doi: 10.1093/hropen/hoad036. eCollection 2023.

  PMID: 38455033 DERIVED

• Boedt T, Matthys C, Lie Fong S, De Neubourg D, Vereeck S, Seghers J, Van der Gucht K, Weyn B, Geerts D, Spiessens C, Dancet EAF. Systematic development of a mobile preconception lifestyle programme for couples undergoing IVF: the PreLiFe-programme. Hum Reprod. 2021 Aug 18;36(9):2493-2505. doi: 10.1093/humrep/deab166.

  PMID: 34379119 DERIVED

• Boedt T, Dancet E, Lie Fong S, Peeraer K, De Neubourg D, Pelckmans S, van de Vijver A, Seghers J, Van der Gucht K, Van Calster B, Spiessens C, Matthys C. Effectiveness of a mobile preconception lifestyle programme in couples undergoing in vitro fertilisation (IVF): the protocol for the PreLiFe randomised controlled trial (PreLiFe-RCT). BMJ Open. 2019 Jul 30;9(7):e029665. doi: 10.1136/bmjopen-2019-029665.

  PMID: 31366659 DERIVED

MeSH Terms

Conditions

Infertility; Motor Activity

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Behavior

Study Officials

• Sharon Lie Fong, MD, PhD

  KU Leuven, UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Statistician is blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial (1:1)

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: December 31, 2018
• Study Start: January 2, 2019
• Primary Completion: June 13, 2020
• Study Completion: March 13, 2021
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Data will become available from 9-36 months after the publication of the RCT-results by the PreLiFe research team.
• Access Criteria: Data will only be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be shared to achieve aims in the approved proposal and for individual participant meta-analysis. Proposals should be directed to christophe.matthys@uzleuven.be (https://orcid.org/0000-0003-1770-6862). To gain access, data requestors will need to sign a data access agreement.

Locations

BE (5)