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Life StyleCOLIFENCT04589793

COaching Lifestyle Intervention for FErtility

A study testing Life Style in people with Life Style and Fertility Disorders, run by Helsinki University Central Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Life Style, Fertility Disorders
What is being tested?
Life Style
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,560 participants
Where
No sites listed yet
Study dates
Oct 2021to Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • infertility
  • BMI 27-34.9 kg/m2

Who cannot join

  • 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)

Trial locations and contacts

No sites are listed yet.

Maritta Poyhonen-Alho, PhD contact

+358 50 428 4690

maritta.poyhonen-alho@hus.fi

Paivi Joki-Korpela, PhD contact

+358

paivi.joki-korpela@hus.fi

About this study

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.

Being tested
Life Style
Keywords
Infertility, Life Style, Physical activity, Diet, Sleep and stress, Intervention, Obesity
Medical subject headings
Infertility, Motor Activity, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Life StyleBehavioural

    Life Style intervention including physical activity, diet, sleep and stress

Study groups in NCT04589793
Study groupRoleWhat they receive
ControlNo interventionConventional treatment
InterventionActive comparatorMotivational interview
Receives: Behavioral: Life Style

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months

  2. Live birth rate

    Number of live children born

    Measured: 3 years

  3. Weight change

    weight in kg measured without shoes and with light clothing at the beginning, at 3 and 6 months

    Measured: 6 months

Secondary outcomes (96)

  1. Infertility treatments, number

    Number of infertility treatments needed for a live birth

    Measured: 3 years

  2. Infertility treatments, mode

    Mode of infertility treatments needed for a live birth (including ovulation induction, insemination, IVF, ICSI)

    Measured: 3 years

  3. Miscarriage rate

    Number of miscarriages

    Measured: 3 years

  4. Height

    Measured without shoes (cm)

    Measured: 0 months

  5. Weight

    Measured without shoes and with light clothing (kg)

    Measured: 0 months

  6. Weight

    Measured without shoes and with light clothing (kg)

    Measured: 3 months

  7. Weight

    Measured without shoes and with light clothing (kg)

    Measured: 6 months

  8. Body mass index

    Weight in kilograms divided by the square of height in meters

    Measured: 0 months

  9. Body mass index

    Weight in kilograms divided by the square of height in meters

    Measured: 3 months

  10. Body mass index

    Weight in kilograms divided by the square of height in meters

    Measured: 6 months

  11. Body composition

    Bioimpedance method

    Measured: 0 months

  12. Body composition

    Bioimpedance method

    Measured: 3 months

  13. Body composition

    Bioimpedance method

    Measured: 6 months

  14. Waist circumference

    measured at midpoint between the lower margin of the last palpable rib and the top of the iliac crest (cm)

    Measured: 0 months

  15. Waist circumference

    measured at midpoint between the lower margin of the last palpable rib and the top of the iliac crest (cm)

    Measured: 3 months

  16. Waist circumference

    measured at midpoint between the lower margin of the last palpable rib and the top of the iliac crest (cm)

    Measured: 6 months

  17. Self-reported physical activity

    Minutes per week, International Physical Activity Questionnaire - Short Form

    Measured: 0 months

  18. Self-reported physical activity

    Minutes per week, International Physical Activity Questionnaire - Short Form

    Measured: 6 months

  19. Physical activity

    Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer

    Measured: 0 months

  20. Physical activity

    Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer

    Measured: 3 months

  21. Physical activity

    Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer

    Measured: 6 months

  22. Maximal oxygen uptake

    Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990

    Measured: 0 months

  23. Maximal oxygen uptake

    Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990

    Measured: 3 months

  24. Maximal oxygen uptake

    Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990

    Measured: 6 months

  25. Dietary content

    FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)

    Measured: 0 months

  26. Dietary content

    FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)

    Measured: 6 months

  27. Dietary patterns

    FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)

    Measured: 0 months

  28. Dietary patterns

    FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)

    Measured: 6 months

  29. Folate

    Plasma folate concentration

    Measured: 0 months

  30. Folate

    Plasma folate concentration

    Measured: 6 months

  31. Vitamin-D

    Plasma vitamin-D concentration

    Measured: 0 months

  32. Vitamin-D

    Plasma vitamin-D concentration

    Measured: 6 months

  33. Zinc

    Plasma zinc concentration

    Measured: 0 months

  34. Zinc

    Plasma zinc concentration

    Measured: 6 months

  35. Carbohydrates

    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

    Measured: 0 months

  36. Carbohydrates

    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

    Measured: 6 months

  37. Protein

    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

    Measured: 0 months

  38. Protein

    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

    Measured: 6 months

  39. Alcohol

    Alcohol consumption per week, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a

    Measured: 0 months

  40. Alcohol

    Alcohol consumption per week, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a

    Measured: 6 months

  41. n-3 fatty acids

    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

    Measured: 0 months

  42. n-3 fatty acids

    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

    Measured: 6 months

  43. n-6 fatty acids

    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

    Measured: 0 months

  44. n-6 fatty acids

    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

    Measured: 6 months

  45. Saturated fatty acids

    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

    Measured: 0 months

  46. Saturated fatty acids

    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

    Measured: 6 months

  47. Monounsaturated fatty acids

    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

    Measured: 0 months

  48. Monounsaturated fatty acids

    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

    Measured: 6 months

  49. Polyunsaturated fatty acids

    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

    Measured: 0 months

  50. Polyunsaturated fatty acids

    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

    Measured: 6 months

  51. Sleep

    Quality of sleep, Basic Nordic Sleep Questionnaire (BNSQ)

    Measured: 0 months

  52. Sleep

    Quality of sleep, Basic Nordic Sleep Questionnaire (BNSQ)

    Measured: 6 months

  53. Sleep, measured

    Quality, sleep disruptions, total sleep duration registered by Oura ring application

    Measured: 0 months

  54. Sleep, measured

    Quality, sleep disruptions, total sleep duration registered by Oura ring application

    Measured: 3 months

  55. Sleep, measured

    Quality, sleep disruptions, total sleep duration registered by Oura ring application

    Measured: 6 months

  56. Stress recovery

    Night-time heart rate variability regisered by Oura ring application

    Measured: 0 months

  57. Stress recovery

    Night-time heart rate variability registered by Oura ring application

    Measured: 3 months

  58. Stress recovery

    Night-time heart rate variability registered by Oura ring application

    Measured: 6 months

  59. Anxiety and depression

    Hospital Anxiety and Depression Scale (HADS)

    Measured: 0 months

  60. Anxiety and depression

    Hospital Anxiety and Depression Scale (HADS)

    Measured: 3 months

  61. Anxiety and depression

    Hospital Anxiety and Depression Scale (HADS)

    Measured: 6 months

  62. Fertility quality of life

    FertiQoL International Questionnaire

    Measured: 0 months

  63. Fertility quality of life

    FertiQoL International Questionnaire

    Measured: 6 months

  64. Depression

    Edinburgh Postnatal Depression Scale (EPDS) Questionnaire

    Measured: 0 months

  65. Depression

    Edinburgh Postnatal Depression Scale (EPDS) Questionnaire

    Measured: 6 months

  66. Self-determined motivation for physical activity

    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.

    Measured: 0 months

  67. Self-determined motivation for physical activity

    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

    Measured: 6 months

  68. Intention and action planning for physical activity; Intention to increase physical activity

    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)

    Measured: 0 months

  69. Intention and action planning for physical activity; Intention to increase physical activity

    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)

    Measured: 6 months

  70. Self-efficacy for physical activity

    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)

    Measured: 0 months

  71. Self-efficacy for physical activity

    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)

    Measured: 6 months

  72. Pregnancy complications

    Number of pregnancy complications (gestational diabetes, pre-eclampsia, hypertension, fetal growth disorders, preterm birth)

    Measured: 3 years

  73. Delivery complications

    Number of delivery complications (cesarean section, assisted vaginal delivery, hemorrhage)

    Measured: 3 years

  74. Neonatal outcome

    Birth weight, cord pH, Apgar score

    Measured: 3 years

  75. Body composition of the newborn

    Bioimpedance method

    Measured: At birth

  76. Growth of the child

    From the records of the national child care centers and schools

    Measured: Up to 16 years of age

  77. Sperm epigenetic profile

    Determination of heritable phenotype

    Measured: 0 months

  78. Sperm epigenetic profile

    Determination of heritable phenotype

    Measured: 6 months

  79. Transcriptome

    RNA-sequencing

    Measured: 0 months

  80. Transcriptome

    RNA-sequencing

    Measured: 6 months

  81. Sperm oxidative stress

    the Male infertility Oxidative System test (MiOXSYS)

    Measured: 0 months

  82. Sperm oxidative stress

    the Male infertility Oxidative System test (MiOXSYS)

    Measured: 6 months

  83. A cost-utility of the intervention

    analysis based on WHOQOL-BREF Questionnaire and FertiQoL, relating the quality-adjusted life years (QALYS) to the costs of the intervention

    Measured: 3 years

  84. QALY baseline

    WHOQOL-BREF Questionnaire and FertiQoL International Questionnaire

    Measured: 0 months

  85. QALY end point

    WHOQOL-BREF Questionnaire and FertiQoL International Questionnaire

    Measured: 6 months

  86. Cost-effectiveness

    ICER

    Measured: 3 years

  87. Static postural balance

    Absolute reach distance measured on balance board, cm (FTC Functional training Company GmbH, AM Haag 10 D-82166 Gräfelfing Germany)

    Measured: 0 months

  88. Static postural balance

    Absolute reach distance measured on balance board, cm (FTC Functional training Company GmbH, AM Haag 10 D-82166 Gräfelfing Germany)

    Measured: 1st trimester of pregnancy

  89. Static postural balance

    Absolute reach distance measured on balance board, cm (FTC Functional training Company GmbH, AM Haag 10 D-82166 Gräfelfing Germany)

    Measured: 2nd trimester of pregnancy

  90. Static postural balance

    Absolute reach distance measured on balance board, cm (FTC Functional training Company GmbH, AM Haag 10 D-82166 Gräfelfing Germany)

    Measured: 3rd trimester of pregnancy

  91. Static postural balance

    Absolute reach distance measured on balance board, cm (FTC Functional training Company GmbH, AM Haag 10 D-82166 Gräfelfing Germany)

    Measured: 3 months postpartum

  92. Perception of stress

    Perceived Stress Scale by Sheldon Cohen

    Measured: 0 months

  93. Perception of stress

    Perceived Stress Scale by Sheldon Cohen

    Measured: 3 months

  94. Perception of stress

    Perceived Stress Scale by Sheldon Cohen

    Measured: 6 months

  95. Personality dimensions

    The Big Five Personality Test

    Measured: 0 months

  96. Personality dimensions

    The Big Five Personality Test

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2020
  2. Study startOct 2021 (estimated)
  3. Primary completionSep 2024 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
None (open label)
Enrolment
1,560 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04589793
Sponsor's protocol ID
TYH2020338
Acronym
COLIFE
Status last verified
Aug 2021
First submitted
9 Oct 2020
Last updated
12 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: According to request and after consideration of the study group

Questions about this trial

What is this clinical trial studying?

A study testing Life Style in people with Life Style and Fertility Disorders, run by Helsinki University Central Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Maritta Poyhonen-Alho, PhD (+358 50 428 4690, maritta.poyhonen-alho@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Behavior change (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04589793.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.

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