COaching Lifestyle Intervention for FErtility (COLIFE)
6. august 2021 opdateret af: Maritta Poyhonen-Alho, Helsinki University Central Hospital
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
1560
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Maritta Poyhonen-Alho, PhD
- Telefonnummer: +358 50 428 4690
- E-mail: maritta.poyhonen-alho@hus.fi
Undersøgelse Kontakt Backup
- Navn: Paivi Joki-Korpela, PhD
- Telefonnummer: +358
- E-mail: paivi.joki-korpela@hus.fi
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 40 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- infertility
- BMI 27-34.9 kg/m2
Exclusion Criteria:
- 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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Styring
Konventionel behandling
|
|
|
Aktiv komparator: Intervention
Motivational interview
|
Life Style intervention including physical activity, diet, sleep and stress
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Behavior change
Tidsramme: 6 months
|
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
Tidsramme: 3 years
|
Number of live children born
|
3 years
|
|
Weight change
Tidsramme: 6 months
|
weight in kg measured without shoes and with light clothing at the beginning, at 3 and 6 months
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Infertility treatments, number
Tidsramme: 3 years
|
Number of infertility treatments needed for a live birth
|
3 years
|
|
Infertility treatments, mode
Tidsramme: 3 years
|
Mode of infertility treatments needed for a live birth (including ovulation induction, insemination, IVF, ICSI)
|
3 years
|
|
Miscarriage rate
Tidsramme: 3 years
|
Number of miscarriages
|
3 years
|
|
Height
Tidsramme: 0 months
|
Measured without shoes (cm)
|
0 months
|
|
Weight
Tidsramme: 0 months
|
Measured without shoes and with light clothing (kg)
|
0 months
|
|
Weight
Tidsramme: 3 months
|
Measured without shoes and with light clothing (kg)
|
3 months
|
|
Weight
Tidsramme: 6 months
|
Measured without shoes and with light clothing (kg)
|
6 months
|
|
Body mass index
Tidsramme: 0 months
|
Weight in kilograms divided by the square of height in meters
|
0 months
|
|
Body mass index
Tidsramme: 3 months
|
Weight in kilograms divided by the square of height in meters
|
3 months
|
|
Body mass index
Tidsramme: 6 months
|
Weight in kilograms divided by the square of height in meters
|
6 months
|
|
Body composition
Tidsramme: 0 months
|
Bioimpedance method
|
0 months
|
|
Body composition
Tidsramme: 3 months
|
Bioimpedance method
|
3 months
|
|
Body composition
Tidsramme: 6 months
|
Bioimpedance method
|
6 months
|
|
Waist circumference
Tidsramme: 0 months
|
measured at midpoint between the lower margin of the last palpable rib and the top of the iliac crest (cm)
|
0 months
|
|
Waist circumference
Tidsramme: 3 months
|
measured at midpoint between the lower margin of the last palpable rib and the top of the iliac crest (cm)
|
3 months
|
|
Waist circumference
Tidsramme: 6 months
|
measured at midpoint between the lower margin of the last palpable rib and the top of the iliac crest (cm)
|
6 months
|
|
Self-reported physical activity
Tidsramme: 0 months
|
Minutes per week, International Physical Activity Questionnaire - Short Form
|
0 months
|
|
Self-reported physical activity
Tidsramme: 6 months
|
Minutes per week, International Physical Activity Questionnaire - Short Form
|
6 months
|
|
Physical activity
Tidsramme: 0 months
|
Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
|
0 months
|
|
Physical activity
Tidsramme: 3 months
|
Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
|
3 months
|
|
Physical activity
Tidsramme: 6 months
|
Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
|
6 months
|
|
Maximal oxygen uptake
Tidsramme: 0 months
|
Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
|
0 months
|
|
Maximal oxygen uptake
Tidsramme: 3 months
|
Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
|
3 months
|
|
Maximal oxygen uptake
Tidsramme: 6 months
|
Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
|
6 months
|
|
Dietary content
Tidsramme: 0 months
|
FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)
|
0 months
|
|
Dietary content
Tidsramme: 6 months
|
FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)
|
6 months
|
|
Dietary patterns
Tidsramme: 0 months
|
FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)
|
0 months
|
|
Dietary patterns
Tidsramme: 6 months
|
FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)
|
6 months
|
|
Folate
Tidsramme: 0 months
|
Plasma folate concentration
|
0 months
|
|
Folate
Tidsramme: 6 months
|
Plasma folate concentration
|
6 months
|
|
Vitamin-D
Tidsramme: 0 months
|
Plasma vitamin-D concentration
|
0 months
|
|
Vitamin-D
Tidsramme: 6 months
|
Plasma vitamin-D concentration
|
6 months
|
|
Zinc
Tidsramme: 0 months
|
Plasma zinc concentration
|
0 months
|
|
Zinc
Tidsramme: 6 months
|
Plasma zinc concentration
|
6 months
|
|
Carbohydrates
Tidsramme: 0 months
|
Amount of daily carbohydrates in diet , FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
|
0 months
|
|
Carbohydrates
Tidsramme: 6 months
|
Amount of daily carbohydrates in diet, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
|
6 months
|
|
Protein
Tidsramme: 0 months
|
Amount of daily proteins in diet, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
|
0 months
|
|
Protein
Tidsramme: 6 months
|
Amount of daily proteins in diet, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
|
6 months
|
|
Alcohol
Tidsramme: 0 months
|
Alcohol consumption per week, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
|
0 months
|
|
Alcohol
Tidsramme: 6 months
|
Alcohol consumption per week, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
|
6 months
|
|
n-3 fatty acids
Tidsramme: 0 months
|
Amount of daily n-3 fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
|
0 months
|
|
n-3 fatty acids
Tidsramme: 6 months
|
Amount of daily n-3 fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
|
6 months
|
|
n-6 fatty acids
Tidsramme: 0 months
|
Amount of daily n-6 fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
|
0 months
|
|
n-6 fatty acids
Tidsramme: 6 months
|
Amount of daily n-6 fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
|
6 months
|
|
Saturated fatty acids
Tidsramme: 0 months
|
Amount of daily saturated fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
|
0 months
|
|
Saturated fatty acids
Tidsramme: 6 months
|
Amount of daily saturated fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
|
6 months
|
|
Monounsaturated fatty acids
Tidsramme: 0 months
|
Amount of daily monounsaturated fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
|
0 months
|
|
Monounsaturated fatty acids
Tidsramme: 6 months
|
Amount of daily monounsaturated fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
|
6 months
|
|
Polyunsaturated fatty acids
Tidsramme: 0 months
|
Amount of daily polyunsaturated fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
|
0 months
|
|
Polyunsaturated fatty acids
Tidsramme: 6 months
|
Amount of daily polyunsaturated fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
|
6 months
|
|
Sleep
Tidsramme: 0 months
|
Quality of sleep, Basic Nordic Sleep Questionnaire (BNSQ)
|
0 months
|
|
Sleep
Tidsramme: 6 months
|
Quality of sleep, Basic Nordic Sleep Questionnaire (BNSQ)
|
6 months
|
|
Sleep, measured
Tidsramme: 0 months
|
Quality, sleep disruptions, total sleep duration registered by Oura ring application
|
0 months
|
|
Sleep, measured
Tidsramme: 3 months
|
Quality, sleep disruptions, total sleep duration registered by Oura ring application
|
3 months
|
|
Sleep, measured
Tidsramme: 6 months
|
Quality, sleep disruptions, total sleep duration registered by Oura ring application
|
6 months
|
|
Stress recovery
Tidsramme: 0 months
|
Night-time heart rate variability regisered by Oura ring application
|
0 months
|
|
Stress recovery
Tidsramme: 3 months
|
Night-time heart rate variability registered by Oura ring application
|
3 months
|
|
Stress recovery
Tidsramme: 6 months
|
Night-time heart rate variability registered by Oura ring application
|
6 months
|
|
Anxiety and depression
Tidsramme: 0 months
|
Hospital Anxiety and Depression Scale (HADS)
|
0 months
|
|
Anxiety and depression
Tidsramme: 3 months
|
Hospital Anxiety and Depression Scale (HADS)
|
3 months
|
|
Angst og depression
Tidsramme: 6 måneder
|
Hospital Angst and Depression Scale (HADS)
|
6 måneder
|
|
Fertility quality of life
Tidsramme: 0 months
|
FertiQoL International Questionnaire
|
0 months
|
|
Fertility quality of life
Tidsramme: 6 months
|
FertiQoL International Questionnaire
|
6 months
|
|
Depression
Tidsramme: 0 months
|
Edinburgh Postnatal Depression Scale (EPDS) Questionnaire
|
0 months
|
|
Depression
Tidsramme: 6 months
|
Edinburgh Postnatal Depression Scale (EPDS) Questionnaire
|
6 months
|
|
Self-determined motivation for physical activity
Tidsramme: 0 months
|
Behavioral Regulations for Exercise Questionnaire (BREQ-3, Markland, D. & Tobin, 2004).
Includes the subscales: Amotivation, External regulation, Introjected regulation, Identified regulation, Integrated regulation, Intrinsic regulation.
|
0 months
|
|
Self-determined motivation for physical activity
Tidsramme: 6 months
|
Behavioral Regulations for Exercise Questionnaire (BREQ-3, Markland, D. & Tobin, 2004).
Includes the subscales: Amotivation, External regulation, Introjected regulation, Identified regulation, Integrated regulation, Intrinsic regulation
|
6 months
|
|
Intention and action planning for physical activity; Intention to increase physical activity
Tidsramme: 0 months
|
Three (adapted) items from the Health Action Process Approach Questionnaire, (Schwarzer R. Modeling health behaviour change: how to predict and modify the adoption and maintenance of health behaviors.
Appl Psychol, 2008; 57:1-29)
|
0 months
|
|
Intention and action planning for physical activity; Intention to increase physical activity
Tidsramme: 6 months
|
Three (adapted) items from the Health Action Process Approach Questionnaire (Schwarzer R. Modeling health behaviour change: how to predict and modify the adoption and maintenance of health behaviors.
Appl Psychol, 2008; 57:1-29)
|
6 months
|
|
Self-efficacy for physical activity
Tidsramme: 0 months
|
18-item scale developed by Albert Bandura (Bandura A. 2006).
Guide for constructing self-efficacy scales.
In: Pajares F, Urdan T (eds)Self-efficacy beliefs of adolescents.
Information Age, Charlotte, pp 307-337)
|
0 months
|
|
Self-efficacy for physical activity
Tidsramme: 6 months
|
18-item scale developed by Albert Bandura (Bandura A. 2006).
Guide for constructing self-efficacy scales.
In: Pajares F, Urdan T (eds)Self-efficacy beliefs of adolescents.
Information Age, Charlotte, pp 307-337)
|
6 months
|
|
Pregnancy complications
Tidsramme: 3 years
|
Number of pregnancy complications (gestational diabetes, pre-eclampsia, hypertension, fetal growth disorders, preterm birth)
|
3 years
|
|
Delivery complications
Tidsramme: 3 years
|
Number of delivery complications (cesarean section, assisted vaginal delivery, hemorrhage)
|
3 years
|
|
Neonatal outcome
Tidsramme: 3 years
|
Birth weight, cord pH, Apgar score
|
3 years
|
|
Body composition of the newborn
Tidsramme: At birth
|
Bioimpedance method
|
At birth
|
|
Growth of the child
Tidsramme: Up to 16 years of age
|
From the records of the national child care centers and schools
|
Up to 16 years of age
|
|
Sperm epigenetic profile
Tidsramme: 0 months
|
Determination of heritable phenotype
|
0 months
|
|
Sperm epigenetic profile
Tidsramme: 6 months
|
Determination of heritable phenotype
|
6 months
|
|
Transcriptome
Tidsramme: 0 months
|
RNA-sequencing
|
0 months
|
|
Transcriptome
Tidsramme: 6 months
|
RNA-sequencing
|
6 months
|
|
Sperm oxidative stress
Tidsramme: 0 months
|
the Male infertility Oxidative System test (MiOXSYS)
|
0 months
|
|
Sperm oxidative stress
Tidsramme: 6 months
|
the Male infertility Oxidative System test (MiOXSYS)
|
6 months
|
|
A cost-utility of the intervention
Tidsramme: 3 years
|
analysis based on WHOQOL-BREF Questionnaire and FertiQoL, relating the quality-adjusted life years (QALYS) to the costs of the intervention
|
3 years
|
|
QALY baseline
Tidsramme: 0 months
|
WHOQOL-BREF Questionnaire and FertiQoL International Questionnaire
|
0 months
|
|
QALY end point
Tidsramme: 6 months
|
WHOQOL-BREF Questionnaire and FertiQoL International Questionnaire
|
6 months
|
|
Cost-effectiveness
Tidsramme: 3 years
|
ICER
|
3 years
|
|
Static postural balance
Tidsramme: 0 months
|
Absolute reach distance measured on balance board, cm (FTC Functional training Company GmbH, AM Haag 10 D-82166 Gräfelfing Germany)
|
0 months
|
|
Static postural balance
Tidsramme: 1st trimester of pregnancy
|
Absolute reach distance measured on balance board, cm (FTC Functional training Company GmbH, AM Haag 10 D-82166 Gräfelfing Germany)
|
1st trimester of pregnancy
|
|
Static postural balance
Tidsramme: 2nd trimester of pregnancy
|
Absolute reach distance measured on balance board, cm (FTC Functional training Company GmbH, AM Haag 10 D-82166 Gräfelfing Germany)
|
2nd trimester of pregnancy
|
|
Static postural balance
Tidsramme: 3rd trimester of pregnancy
|
Absolute reach distance measured on balance board, cm (FTC Functional training Company GmbH, AM Haag 10 D-82166 Gräfelfing Germany)
|
3rd trimester of pregnancy
|
|
Static postural balance
Tidsramme: 3 months postpartum
|
Absolute reach distance measured on balance board, cm (FTC Functional training Company GmbH, AM Haag 10 D-82166 Gräfelfing Germany)
|
3 months postpartum
|
|
Perception of stress
Tidsramme: 0 months
|
Perceived Stress Scale by Sheldon Cohen
|
0 months
|
|
Perception of stress
Tidsramme: 3 months
|
Perceived Stress Scale by Sheldon Cohen
|
3 months
|
|
Perception of stress
Tidsramme: 6 months
|
Perceived Stress Scale by Sheldon Cohen
|
6 months
|
|
Personality dimensions
Tidsramme: 0 months
|
The Big Five Personality Test
|
0 months
|
|
Personality dimensions
Tidsramme: 6 months
|
The Big Five Personality Test
|
6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Juha Tapanainen, professor, Helsinki University Central Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. oktober 2021
Primær færdiggørelse (Forventet)
1. september 2024
Studieafslutning (Forventet)
1. september 2025
Datoer for studieregistrering
Først indsendt
9. oktober 2020
Først indsendt, der opfyldte QC-kriterier
9. oktober 2020
Først opslået (Faktiske)
19. oktober 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. august 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. august 2021
Sidst verificeret
1. august 2021
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- TYH2020338
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
IPD-planbeskrivelse
According to request and after consideration of the study group
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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