Evaluation of a Mobile Preconception Lifestyle Programme in Couples Undergoing In Vitro Fertilisation (PreLiFe-RCT)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03790449 |
|
Recruitment Status :
Terminated
(Due to the worldwide Covid-19 pandemic, all Belgian fertility clinics stopped offering IVF as of March 13th 2020. We had to stop recruitment and follow-up of study subjects. We therefore adjusted our primary outcome to time to ongoing pregnancy.)
First Posted : December 31, 2018
Last Update Posted : May 10, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Infertility | Behavioral: PreLiFe-programme Behavioral: Attention Control Programme | Not Applicable |
Introduction: Infertility and in vitro fertilization (IVF; with or without intracytoplasmic sperm injection, ICSI) result in considerate emotional and financial burden. Increasing evidence suggests that lifestyle factors, including diet, physical activity and personal wellbeing, are associated with IVF-success rates. So far, IVF is not routinely combined with a lifestyle programme. The PreLiFe randomized controlled trial (RCT) will assess the effects of a new mobile preconception lifestyle programme (PreLiFe-programme) in couples undergoing IVF.
Methods and analysis: A multicentre RCT will include heterosexual couples about to start IVF (with or without ICSI) in Belgian fertility clinics. IVF-Couples will be randomized between an attention control programme or the PreLiFe-programme for 12 months or until an ongoing pregnancy is confirmed by ultrasound. The attention control programme includes a mobile application with treatment information (i.e. appointments and medication instructions) in addition to standard care. The PreLiFe-programme includes a mobile application with the same treatment information in combination with a lifestyle programme. This new lifestyle programme includes tailored advice on diet and physical activity and mindfulness exercises in combination with text messages and telephone interaction with a lifestyle coach. The primary outcome of this RCT is the cumulative ongoing pregnancy rate within 12 months after randomisation. Secondary outcomes include changes in diet, physical activity, personal wellbeing, body mass index, waist circumference and quality of life measured with self-reported questionnaires and physical assessments and changes in other reproductive outcomes including clinical pregnancy and time to pregnancy. Additionally, the partners' support and the feasibility (use and acceptability) of the PreLiFe-programme will be evaluated using self-reported questionnaires and app-based tracking. Analysis will be according to intention to treat.
Ethics and dissemination: This study has been approved by the Medical Ethical Committee of the Leuven University Hospital (Belgium) and of the other recruiting clinics. The findings of this RCT will be disseminated through presentations at international scientific meetings and peer-reviewed publications.
Due to the worldwide Covid-19 pandemic, we had to stop recruiting new patients and stop studying patients who were in the midst of their 12 months study period. This was inevitable as all Belgian fertility clinics stopped offering IVF as of March 13th 2020 for a (not predefined) period. Patients who had been randomized, but were still ongoing in the trial at that time needed to be censored. Based on statistical advise, we changed therefore our primary outcome analysis from cumulative ongoing pregnancy rate within 12 months after randomisation to time to ongoing pregnancy in order to be able to use the data of the many study patients who were in the midst of their 12 months study period.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 211 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomized Controlled Trial (1:1) |
| Masking: | None (Open Label) |
| Masking Description: | Statistician is blinded |
| Primary Purpose: | Supportive Care |
| Official Title: | Evaluation of a Mobile Preconception Lifestyle Programme in Couples Undergoing in Vitro Fertilisation: a Multicentre Randomized Controlled Trial (PreLiFe-RCT) |
| Actual Study Start Date : | January 2, 2019 |
| Actual Primary Completion Date : | June 13, 2020 |
| Actual Study Completion Date : | March 13, 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: PreLiFe-programme
A Mobile Preconception Lifestyle programme
|
Behavioral: PreLiFe-programme
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. Behavioral: Attention Control Programme 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
Attention Control Programme
|
Behavioral: Attention Control Programme
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. |
- Cumulative ongoing pregnancy rate (COPR) within 12 months after randomisation [ Time Frame: 12 months ]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.
- Changes in diet assessed with a Food Frequency Questionnaire (FFQ) [ Time Frame: at baseline, 3 months, 6 months, 9 months and 12 months after randomisation ]A validated food frequency questionnaire (FFQ) is used to evaluate changes in dietary pattern and diet quality over time and to evaluate differences in the dietary pattern and diet quality between the intervention and attention control group. The FFQ consists of a finite list of foods and beverages with response categories to indicate usual frequency and portion size of consumption over the last month. Diet quality is calculated from the FFQ by assessing quality, balance and variety of foods and beverages consumed (score 0-100 with the higher the better diet quality). Diet quality is an index to reflect compliance with the Belgian Food Based Dietary Guidelines.
- Changes in physical activity assessed with the International Physical Activity Questionnaire (IPAQ) [ Time Frame: at baseline, 3 months, 6 months, 9 months and 12 months after randomisation ]The International Physical Activity Questionnaire Short Form (IPAQ-SF) is used to evaluate changes in physical activity over time and to evaluate differences in physical activity between the intervention and attention control group. The IPAQ-SF assesses the duration (in minutes) and frequency (in days) of walking, moderate-intensity activities, vigorous-intensity activities and sedentary activity (sitting) based on metabolic equivalent (MET) values. Self-reported physical activity is classified as low, moderate or high physically active based on the global recommendations on physical activity for health of the World Health Organisation. The IPAQ-SF is a reliable and validated instrument for monitoring physical activity in population health surveillance systems.
- Changes in symptoms of emotional distress, anxiety and depression (personal wellbeing) assessed with the Depression, anxiety and stress scale (DASS-21) [ Time Frame: at baseline, 3 months, 6 months, 9 months and 12 months after randomisation ]The Depression, anxiety and stress scale (DASS-21) is used to evaluate changes in personal wellbeing over time and to evaluate differences in personal wellbeing between the intervention and attention control group. Self-reported symptoms of stress, anxiety and depression (together emotional distress) are measured with this validated scale (score 0-126 with the lower, the higher personal wellbeing).
- Changes in fertility related quality of life assessed with the Fertility Quality of Life Tool (FERTIQOL). [ Time Frame: at baseline, 3 months, 6 months, 9 months and 12 months after randomisation ]The Fertility Quality of Life Tool (FERTIQOL) is used to evaluate changes in fertility related quality of life over time and to evaluate differences in fertility related quality of life between the intervention and attention control group. Self-reported fertility related quality of life is measured with this validated scale (score 0-100 with the higher, the better fertility related quality of life).
- Changes in Body Mass Index (BMI) [ Time Frame: at baseline, 3 months, 6 months, 9 months and 12 months after randomisation ]Weight and height are measured according to International Standards for Anthropometric Assessment. Weight is measured when wearing light clothes and no shoes on a calibrated scale. Height is measured without shoes on a stadiometer. Weight and height allow body mass index (BMI) calculation. Changes in BMI over time and differences in BMI between the intervention and attention control group are evaluated.
- Changes in waist circumference measured with a measuring tape [ Time Frame: at baseline, 3 months, 6 months, 9 months and 12 months after randomisation ]Waist circumference is measured according to International Standards for Anthropometric Assessment with a SECA measuring tape to estimate abdominal fat. Changes in waist circumference over time and differences in waist circumference between the intervention and attention control group are evaluated.
- Number of clinical pregnancies [ Time Frame: 12 months ]Clinical pregnancy defined as evidence of a gestational sac confirmed by ultrasound. Dichotomous outcome (yes-no). Differences in number of clinical pregnancies between the intervention and attention control group are evaluated.
- Time to pregnancy [ Time Frame: 12 months ]Differences in time to pregnancy between the intervention and attention control group are evaluated.
- Use of the PreLiFe-programme assessed with app based tracking [ Time Frame: at 3 months, 6 months, 9 months and 12 months after randomisation ]The use of the PreLiFe-programme is assessed in the intervention group by evaluating the % of participants using the PreLiFe-programme by app-based tracking.
- Acceptability of the PreLiFe-programme assessed with a subscale of the Mobile App Rating Scale (MARS) [ Time Frame: 12 months ]The acceptability of the PreLiFe-programme is assessed at the end of the study in the intervention group with a shortened version of the subjective quality subscale of the Mobile App Rating Scale (MARS)(score 0-10 with the higher the better subjective quality of the PreLiFe-programme).
- Partners' support assessed with a questionnaire [ Time Frame: at 3 months, 6 months, 9 months and 12 months after randomisation ]The partner's support during the PreLiFe-programme is assessed in the intervention group with a self-developed questionnaire to evaluate if they feel supported by their partner in maintaining a healthy lifestyle.This self-developed questionnaire is based on "The Social Support for Diet and Exercise scale of Sallis et al. (1987). It consists of 3 subscales: partners' support for diet (0-10), physical activity (0-15) and personal wellbeing (0-10), with the higher the better the partner's support.
- Occurrence of adverse events [ Time Frame: 12 months ]Differences in the occurrence of adverse events (data obtained from medical records) between the intervention and attention control group are evaluated.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03790449
| Belgium | |
| University Hospital Antwerp | |
| Antwerp, Belgium, 2000 | |
| Imelda Hospital Bonheiden | |
| Bonheiden, Belgium, 2820 | |
| Academic Hospital Sint Jan Bruges-Ostend | |
| Bruges, Belgium, 8000 | |
| Academic Hospital Diest | |
| Diest, Belgium, 3290 | |
| University Hospitals Leuven | |
| Leuven, Belgium, 3000 | |
| Principal Investigator: | Sharon Lie Fong, MD, PhD | KU Leuven, UZ Leuven |
Documents provided by Universitaire Ziekenhuizen Leuven:
| Responsible Party: | Universitaire Ziekenhuizen Leuven |
| ClinicalTrials.gov Identifier: | NCT03790449 |
| Other Study ID Numbers: |
s61596 |
| First Posted: | December 31, 2018 Key Record Dates |
| Last Update Posted: | May 10, 2021 |
| Last Verified: | May 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | For all the data generated during the course of this project, we will follow the prevailing standards and guidelines in documenting and depositing data sets. The PreLiFe research team will disseminate results from this research through presentations at public lectures, scientific institutions and meetings, and/or publication in major journals. Regarding data sharing, ICMJE recommendations will be followed. Individual deidentified participant data will be shared. In particular, individual participant data that underlie the results reported in our articles, after deindentification (text, tables, figures and appendices). |
| Supporting Materials: |
Study Protocol Informed Consent Form (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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Infertility Lifestyle mobile health |
Diet Physical Activity Mindfulness |
|
Infertility |