COaching Lifestyle Intervention for FErtility (COLIFE)
6 augustus 2021 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Verwacht)
1560
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Maritta Poyhonen-Alho, PhD
- Telefoonnummer: +358 50 428 4690
- E-mail: maritta.poyhonen-alho@hus.fi
Studie Contact Back-up
- Naam: Paivi Joki-Korpela, PhD
- Telefoonnummer: +358
- E-mail: paivi.joki-korpela@hus.fi
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 40 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Geen tussenkomst: Controle
Conventionele behandeling
|
|
|
Actieve vergelijker: Intervention
Motivational interview
|
Life Style intervention including physical activity, diet, sleep and stress
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Behavior change
Tijdsspanne: 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
Tijdsspanne: 3 years
|
Number of live children born
|
3 years
|
|
Weight change
Tijdsspanne: 6 months
|
weight in kg measured without shoes and with light clothing at the beginning, at 3 and 6 months
|
6 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Infertility treatments, number
Tijdsspanne: 3 years
|
Number of infertility treatments needed for a live birth
|
3 years
|
|
Infertility treatments, mode
Tijdsspanne: 3 years
|
Mode of infertility treatments needed for a live birth (including ovulation induction, insemination, IVF, ICSI)
|
3 years
|
|
Miscarriage rate
Tijdsspanne: 3 years
|
Number of miscarriages
|
3 years
|
|
Height
Tijdsspanne: 0 months
|
Measured without shoes (cm)
|
0 months
|
|
Weight
Tijdsspanne: 0 months
|
Measured without shoes and with light clothing (kg)
|
0 months
|
|
Weight
Tijdsspanne: 3 months
|
Measured without shoes and with light clothing (kg)
|
3 months
|
|
Weight
Tijdsspanne: 6 months
|
Measured without shoes and with light clothing (kg)
|
6 months
|
|
Body mass index
Tijdsspanne: 0 months
|
Weight in kilograms divided by the square of height in meters
|
0 months
|
|
Body mass index
Tijdsspanne: 3 months
|
Weight in kilograms divided by the square of height in meters
|
3 months
|
|
Body mass index
Tijdsspanne: 6 months
|
Weight in kilograms divided by the square of height in meters
|
6 months
|
|
Body composition
Tijdsspanne: 0 months
|
Bioimpedance method
|
0 months
|
|
Body composition
Tijdsspanne: 3 months
|
Bioimpedance method
|
3 months
|
|
Body composition
Tijdsspanne: 6 months
|
Bioimpedance method
|
6 months
|
|
Waist circumference
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 0 months
|
Minutes per week, International Physical Activity Questionnaire - Short Form
|
0 months
|
|
Self-reported physical activity
Tijdsspanne: 6 months
|
Minutes per week, International Physical Activity Questionnaire - Short Form
|
6 months
|
|
Physical activity
Tijdsspanne: 0 months
|
Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
|
0 months
|
|
Physical activity
Tijdsspanne: 3 months
|
Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
|
3 months
|
|
Physical activity
Tijdsspanne: 6 months
|
Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
|
6 months
|
|
Maximal oxygen uptake
Tijdsspanne: 0 months
|
Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
|
0 months
|
|
Maximal oxygen uptake
Tijdsspanne: 3 months
|
Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
|
3 months
|
|
Maximal oxygen uptake
Tijdsspanne: 6 months
|
Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
|
6 months
|
|
Dietary content
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 6 months
|
FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)
|
6 months
|
|
Folate
Tijdsspanne: 0 months
|
Plasma folate concentration
|
0 months
|
|
Folate
Tijdsspanne: 6 months
|
Plasma folate concentration
|
6 months
|
|
Vitamin-D
Tijdsspanne: 0 months
|
Plasma vitamin-D concentration
|
0 months
|
|
Vitamin-D
Tijdsspanne: 6 months
|
Plasma vitamin-D concentration
|
6 months
|
|
Zinc
Tijdsspanne: 0 months
|
Plasma zinc concentration
|
0 months
|
|
Zinc
Tijdsspanne: 6 months
|
Plasma zinc concentration
|
6 months
|
|
Carbohydrates
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 0 months
|
Quality of sleep, Basic Nordic Sleep Questionnaire (BNSQ)
|
0 months
|
|
Sleep
Tijdsspanne: 6 months
|
Quality of sleep, Basic Nordic Sleep Questionnaire (BNSQ)
|
6 months
|
|
Sleep, measured
Tijdsspanne: 0 months
|
Quality, sleep disruptions, total sleep duration registered by Oura ring application
|
0 months
|
|
Sleep, measured
Tijdsspanne: 3 months
|
Quality, sleep disruptions, total sleep duration registered by Oura ring application
|
3 months
|
|
Sleep, measured
Tijdsspanne: 6 months
|
Quality, sleep disruptions, total sleep duration registered by Oura ring application
|
6 months
|
|
Stress recovery
Tijdsspanne: 0 months
|
Night-time heart rate variability regisered by Oura ring application
|
0 months
|
|
Stress recovery
Tijdsspanne: 3 months
|
Night-time heart rate variability registered by Oura ring application
|
3 months
|
|
Stress recovery
Tijdsspanne: 6 months
|
Night-time heart rate variability registered by Oura ring application
|
6 months
|
|
Anxiety and depression
Tijdsspanne: 0 months
|
Hospital Anxiety and Depression Scale (HADS)
|
0 months
|
|
Anxiety and depression
Tijdsspanne: 3 months
|
Hospital Anxiety and Depression Scale (HADS)
|
3 months
|
|
Angst en depressie
Tijdsspanne: 6 maanden
|
Ziekenhuis Angst en Depressie Schaal (HADS)
|
6 maanden
|
|
Fertility quality of life
Tijdsspanne: 0 months
|
FertiQoL International Questionnaire
|
0 months
|
|
Fertility quality of life
Tijdsspanne: 6 months
|
FertiQoL International Questionnaire
|
6 months
|
|
Depression
Tijdsspanne: 0 months
|
Edinburgh Postnatal Depression Scale (EPDS) Questionnaire
|
0 months
|
|
Depression
Tijdsspanne: 6 months
|
Edinburgh Postnatal Depression Scale (EPDS) Questionnaire
|
6 months
|
|
Self-determined motivation for physical activity
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 3 years
|
Number of pregnancy complications (gestational diabetes, pre-eclampsia, hypertension, fetal growth disorders, preterm birth)
|
3 years
|
|
Delivery complications
Tijdsspanne: 3 years
|
Number of delivery complications (cesarean section, assisted vaginal delivery, hemorrhage)
|
3 years
|
|
Neonatal outcome
Tijdsspanne: 3 years
|
Birth weight, cord pH, Apgar score
|
3 years
|
|
Body composition of the newborn
Tijdsspanne: At birth
|
Bioimpedance method
|
At birth
|
|
Growth of the child
Tijdsspanne: 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
Tijdsspanne: 0 months
|
Determination of heritable phenotype
|
0 months
|
|
Sperm epigenetic profile
Tijdsspanne: 6 months
|
Determination of heritable phenotype
|
6 months
|
|
Transcriptome
Tijdsspanne: 0 months
|
RNA-sequencing
|
0 months
|
|
Transcriptome
Tijdsspanne: 6 months
|
RNA-sequencing
|
6 months
|
|
Sperm oxidative stress
Tijdsspanne: 0 months
|
the Male infertility Oxidative System test (MiOXSYS)
|
0 months
|
|
Sperm oxidative stress
Tijdsspanne: 6 months
|
the Male infertility Oxidative System test (MiOXSYS)
|
6 months
|
|
A cost-utility of the intervention
Tijdsspanne: 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
Tijdsspanne: 0 months
|
WHOQOL-BREF Questionnaire and FertiQoL International Questionnaire
|
0 months
|
|
QALY end point
Tijdsspanne: 6 months
|
WHOQOL-BREF Questionnaire and FertiQoL International Questionnaire
|
6 months
|
|
Cost-effectiveness
Tijdsspanne: 3 years
|
ICER
|
3 years
|
|
Static postural balance
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 0 months
|
Perceived Stress Scale by Sheldon Cohen
|
0 months
|
|
Perception of stress
Tijdsspanne: 3 months
|
Perceived Stress Scale by Sheldon Cohen
|
3 months
|
|
Perception of stress
Tijdsspanne: 6 months
|
Perceived Stress Scale by Sheldon Cohen
|
6 months
|
|
Personality dimensions
Tijdsspanne: 0 months
|
The Big Five Personality Test
|
0 months
|
|
Personality dimensions
Tijdsspanne: 6 months
|
The Big Five Personality Test
|
6 months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Juha Tapanainen, professor, Helsinki University Central Hospital
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Verwacht)
1 oktober 2021
Primaire voltooiing (Verwacht)
1 september 2024
Studie voltooiing (Verwacht)
1 september 2025
Studieregistratiedata
Eerst ingediend
9 oktober 2020
Eerst ingediend dat voldeed aan de QC-criteria
9 oktober 2020
Eerst geplaatst (Werkelijk)
19 oktober 2020
Updates van studierecords
Laatste update geplaatst (Werkelijk)
12 augustus 2021
Laatste update ingediend die voldeed aan QC-criteria
6 augustus 2021
Laatst geverifieerd
1 augustus 2021
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- TYH2020338
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Nee
Beschrijving IPD-plan
According to request and after consideration of the study group
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .