COaching Lifestyle Intervention for FErtility
COLIFE
1 other identifier
interventional
1,560
0 countries
N/A
Brief Summary
In Finland, every third woman is overweight (BMI\>25) and 11,5% obese (BMI\>30). Cohort and national studies reveal that 46% of fertile-aged men have BMI≥25 and 20% BMI≥30. Overweight has negative impact on both female and male fertility and weakens markedly the results of infertility treatments. In this study, 780 infertile couples will be randomized to control group (conventional infertility treatment) and lifestyle intervention arm undergoing 4 sessions of video-mediated motivational interview, anthropometric measurements, laboratory tests and epigenetic samples. Economic evaluation of the intervention will also be performed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2021
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2020
CompletedFirst Posted
Study publicly available on registry
October 19, 2020
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedAugust 12, 2021
August 1, 2021
2.9 years
October 9, 2020
August 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Behavior change
score from 1 to 4: (smoking + daily vegetable, fruit and berry use \>500g + BMI 19-27 + 150 min of moderate exercise/week) No=0, Yes=1 measured at the beginning, at 3 and 6 months
6 months
Live birth rate
Number of live children born
3 years
Weight change
weight in kg measured without shoes and with light clothing at the beginning, at 3 and 6 months
6 months
Secondary Outcomes (96)
Infertility treatments, number
3 years
Infertility treatments, mode
3 years
Miscarriage rate
3 years
Height
0 months
Weight
0 months
- +91 more secondary outcomes
Study Arms (2)
Control
NO INTERVENTIONConventional treatment
Intervention
ACTIVE COMPARATORMotivational interview
Interventions
Life Style intervention including physical activity, diet, sleep and stress
Eligibility Criteria
You may qualify if:
- infertility
- BMI 27-34.9 kg/m2
You may not qualify if:
- no mobile device available
- evident sperm defect or ovarian tube block
- hinder for fluent treatment schedule due to the subjec´s obstacle (inadequate language skills, major time table problems)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helsinki University Central Hospitallead
- University of Helsinkicollaborator
- University of Eastern Finlandcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juha Tapanainen, professor
Helsinki University Central Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
October 9, 2020
First Posted
October 19, 2020
Study Start
October 1, 2021
Primary Completion
September 1, 2024
Study Completion
September 1, 2025
Last Updated
August 12, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share
According to request and after consideration of the study group