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COaching Lifestyle Intervention for FErtility (COLIFE)

6 augusti 2021 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Förväntat)

1560

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 40 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Kontrollera
Konventionell behandling
Aktiv komparator: Intervention
Motivational interview
Beteende: Life Style
Life Style intervention including physical activity, diet, sleep and stress

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Behavior change
Tidsram: 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
Tidsram: 3 years
Number of live children born
3 years
Weight change
Tidsram: 6 months
weight in kg measured without shoes and with light clothing at the beginning, at 3 and 6 months
6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Infertility treatments, number
Tidsram: 3 years
Number of infertility treatments needed for a live birth
3 years
Infertility treatments, mode
Tidsram: 3 years
Mode of infertility treatments needed for a live birth (including ovulation induction, insemination, IVF, ICSI)
3 years
Miscarriage rate
Tidsram: 3 years
Number of miscarriages
3 years
Height
Tidsram: 0 months
Measured without shoes (cm)
0 months
Weight
Tidsram: 0 months
Measured without shoes and with light clothing (kg)
0 months
Weight
Tidsram: 3 months
Measured without shoes and with light clothing (kg)
3 months
Weight
Tidsram: 6 months
Measured without shoes and with light clothing (kg)
6 months
Body mass index
Tidsram: 0 months
Weight in kilograms divided by the square of height in meters
0 months
Body mass index
Tidsram: 3 months
Weight in kilograms divided by the square of height in meters
3 months
Body mass index
Tidsram: 6 months
Weight in kilograms divided by the square of height in meters
6 months
Body composition
Tidsram: 0 months
Bioimpedance method
0 months
Body composition
Tidsram: 3 months
Bioimpedance method
3 months
Body composition
Tidsram: 6 months
Bioimpedance method
6 months
Waist circumference
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 0 months
Minutes per week, International Physical Activity Questionnaire - Short Form
0 months
Self-reported physical activity
Tidsram: 6 months
Minutes per week, International Physical Activity Questionnaire - Short Form
6 months
Physical activity
Tidsram: 0 months
Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
0 months
Physical activity
Tidsram: 3 months
Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
3 months
Physical activity
Tidsram: 6 months
Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
6 months
Maximal oxygen uptake
Tidsram: 0 months
Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
0 months
Maximal oxygen uptake
Tidsram: 3 months
Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
3 months
Maximal oxygen uptake
Tidsram: 6 months
Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
6 months
Dietary content
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 6 months
FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)
6 months
Folate
Tidsram: 0 months
Plasma folate concentration
0 months
Folate
Tidsram: 6 months
Plasma folate concentration
6 months
Vitamin-D
Tidsram: 0 months
Plasma vitamin-D concentration
0 months
Vitamin-D
Tidsram: 6 months
Plasma vitamin-D concentration
6 months
Zinc
Tidsram: 0 months
Plasma zinc concentration
0 months
Zinc
Tidsram: 6 months
Plasma zinc concentration
6 months
Carbohydrates
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 0 months
Quality of sleep, Basic Nordic Sleep Questionnaire (BNSQ)
0 months
Sleep
Tidsram: 6 months
Quality of sleep, Basic Nordic Sleep Questionnaire (BNSQ)
6 months
Sleep, measured
Tidsram: 0 months
Quality, sleep disruptions, total sleep duration registered by Oura ring application
0 months
Sleep, measured
Tidsram: 3 months
Quality, sleep disruptions, total sleep duration registered by Oura ring application
3 months
Sleep, measured
Tidsram: 6 months
Quality, sleep disruptions, total sleep duration registered by Oura ring application
6 months
Stress recovery
Tidsram: 0 months
Night-time heart rate variability regisered by Oura ring application
0 months
Stress recovery
Tidsram: 3 months
Night-time heart rate variability registered by Oura ring application
3 months
Stress recovery
Tidsram: 6 months
Night-time heart rate variability registered by Oura ring application
6 months
Anxiety and depression
Tidsram: 0 months
Hospital Anxiety and Depression Scale (HADS)
0 months
Anxiety and depression
Tidsram: 3 months
Hospital Anxiety and Depression Scale (HADS)
3 months
Ångest och depression
Tidsram: 6 månader
Hospital Anxiety and Depression Scale (HADS)
6 månader
Fertility quality of life
Tidsram: 0 months
FertiQoL International Questionnaire
0 months
Fertility quality of life
Tidsram: 6 months
FertiQoL International Questionnaire
6 months
Depression
Tidsram: 0 months
Edinburgh Postnatal Depression Scale (EPDS) Questionnaire
0 months
Depression
Tidsram: 6 months
Edinburgh Postnatal Depression Scale (EPDS) Questionnaire
6 months
Self-determined motivation for physical activity
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 3 years
Number of pregnancy complications (gestational diabetes, pre-eclampsia, hypertension, fetal growth disorders, preterm birth)
3 years
Delivery complications
Tidsram: 3 years
Number of delivery complications (cesarean section, assisted vaginal delivery, hemorrhage)
3 years
Neonatal outcome
Tidsram: 3 years
Birth weight, cord pH, Apgar score
3 years
Body composition of the newborn
Tidsram: At birth
Bioimpedance method
At birth
Growth of the child
Tidsram: 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
Tidsram: 0 months
Determination of heritable phenotype
0 months
Sperm epigenetic profile
Tidsram: 6 months
Determination of heritable phenotype
6 months
Transcriptome
Tidsram: 0 months
RNA-sequencing
0 months
Transcriptome
Tidsram: 6 months
RNA-sequencing
6 months
Sperm oxidative stress
Tidsram: 0 months
the Male infertility Oxidative System test (MiOXSYS)
0 months
Sperm oxidative stress
Tidsram: 6 months
the Male infertility Oxidative System test (MiOXSYS)
6 months
A cost-utility of the intervention
Tidsram: 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
Tidsram: 0 months
WHOQOL-BREF Questionnaire and FertiQoL International Questionnaire
0 months
QALY end point
Tidsram: 6 months
WHOQOL-BREF Questionnaire and FertiQoL International Questionnaire
6 months
Cost-effectiveness
Tidsram: 3 years
ICER
3 years
Static postural balance
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 0 months
Perceived Stress Scale by Sheldon Cohen
0 months
Perception of stress
Tidsram: 3 months
Perceived Stress Scale by Sheldon Cohen
3 months
Perception of stress
Tidsram: 6 months
Perceived Stress Scale by Sheldon Cohen
6 months
Personality dimensions
Tidsram: 0 months
The Big Five Personality Test
0 months
Personality dimensions
Tidsram: 6 months
The Big Five Personality Test
6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Helsinki University Central Hospital

Samarbetspartners

University of Helsinki
University of Eastern Finland

Utredare

  • Huvudutredare: Juha Tapanainen, professor, Helsinki University Central Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Förväntat)

1 oktober 2021

Primärt slutförande (Förväntat)

1 september 2024

Avslutad studie (Förväntat)

1 september 2025

Studieregistreringsdatum

Först inskickad

9 oktober 2020

Först inskickad som uppfyllde QC-kriterierna

9 oktober 2020

Första postat (Faktisk)

19 oktober 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 augusti 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 augusti 2021

Senast verifierad

1 augusti 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • TYH2020338

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Nej

IPD-planbeskrivning

According to request and after consideration of the study group

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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