COaching Lifestyle Intervention for FErtility (COLIFE)
2021年8月6日 更新者：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.
調査の概要
研究の種類
介入
入学 (予想される)
1560
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Maritta Poyhonen-Alho, PhD
- 電話番号：+358 50 428 4690
- メール：maritta.poyhonen-alho@hus.fi
研究連絡先のバックアップ
- 名前：Paivi Joki-Korpela, PhD
- 電話番号：+358
- メール：paivi.joki-korpela@hus.fi
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～40年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：コントロール
従来の治療
|
|
|
アクティブコンパレータ：Intervention
Motivational interview
|
Life Style intervention including physical activity, diet, sleep and stress
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Behavior change
時間枠：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
時間枠：3 years
|
Number of live children born
|
3 years
|
|
Weight change
時間枠：6 months
|
weight in kg measured without shoes and with light clothing at the beginning, at 3 and 6 months
|
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Infertility treatments, number
時間枠：3 years
|
Number of infertility treatments needed for a live birth
|
3 years
|
|
Infertility treatments, mode
時間枠：3 years
|
Mode of infertility treatments needed for a live birth (including ovulation induction, insemination, IVF, ICSI)
|
3 years
|
|
Miscarriage rate
時間枠：3 years
|
Number of miscarriages
|
3 years
|
|
Height
時間枠：0 months
|
Measured without shoes (cm)
|
0 months
|
|
Weight
時間枠：0 months
|
Measured without shoes and with light clothing (kg)
|
0 months
|
|
Weight
時間枠：3 months
|
Measured without shoes and with light clothing (kg)
|
3 months
|
|
Weight
時間枠：6 months
|
Measured without shoes and with light clothing (kg)
|
6 months
|
|
Body mass index
時間枠：0 months
|
Weight in kilograms divided by the square of height in meters
|
0 months
|
|
Body mass index
時間枠：3 months
|
Weight in kilograms divided by the square of height in meters
|
3 months
|
|
Body mass index
時間枠：6 months
|
Weight in kilograms divided by the square of height in meters
|
6 months
|
|
Body composition
時間枠：0 months
|
Bioimpedance method
|
0 months
|
|
Body composition
時間枠：3 months
|
Bioimpedance method
|
3 months
|
|
Body composition
時間枠：6 months
|
Bioimpedance method
|
6 months
|
|
Waist circumference
時間枠：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
時間枠：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
時間枠：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
時間枠：0 months
|
Minutes per week, International Physical Activity Questionnaire - Short Form
|
0 months
|
|
Self-reported physical activity
時間枠：6 months
|
Minutes per week, International Physical Activity Questionnaire - Short Form
|
6 months
|
|
Physical activity
時間枠：0 months
|
Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
|
0 months
|
|
Physical activity
時間枠：3 months
|
Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
|
3 months
|
|
Physical activity
時間枠：6 months
|
Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
|
6 months
|
|
Maximal oxygen uptake
時間枠：0 months
|
Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
|
0 months
|
|
Maximal oxygen uptake
時間枠：3 months
|
Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
|
3 months
|
|
Maximal oxygen uptake
時間枠：6 months
|
Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
|
6 months
|
|
Dietary content
時間枠：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
時間枠：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
時間枠：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
時間枠：6 months
|
FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)
|
6 months
|
|
Folate
時間枠：0 months
|
Plasma folate concentration
|
0 months
|
|
Folate
時間枠：6 months
|
Plasma folate concentration
|
6 months
|
|
Vitamin-D
時間枠：0 months
|
Plasma vitamin-D concentration
|
0 months
|
|
Vitamin-D
時間枠：6 months
|
Plasma vitamin-D concentration
|
6 months
|
|
Zinc
時間枠：0 months
|
Plasma zinc concentration
|
0 months
|
|
Zinc
時間枠：6 months
|
Plasma zinc concentration
|
6 months
|
|
Carbohydrates
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：0 months
|
Quality of sleep, Basic Nordic Sleep Questionnaire (BNSQ)
|
0 months
|
|
Sleep
時間枠：6 months
|
Quality of sleep, Basic Nordic Sleep Questionnaire (BNSQ)
|
6 months
|
|
Sleep, measured
時間枠：0 months
|
Quality, sleep disruptions, total sleep duration registered by Oura ring application
|
0 months
|
|
Sleep, measured
時間枠：3 months
|
Quality, sleep disruptions, total sleep duration registered by Oura ring application
|
3 months
|
|
Sleep, measured
時間枠：6 months
|
Quality, sleep disruptions, total sleep duration registered by Oura ring application
|
6 months
|
|
Stress recovery
時間枠：0 months
|
Night-time heart rate variability regisered by Oura ring application
|
0 months
|
|
Stress recovery
時間枠：3 months
|
Night-time heart rate variability registered by Oura ring application
|
3 months
|
|
Stress recovery
時間枠：6 months
|
Night-time heart rate variability registered by Oura ring application
|
6 months
|
|
Anxiety and depression
時間枠：0 months
|
Hospital Anxiety and Depression Scale (HADS)
|
0 months
|
|
Anxiety and depression
時間枠：3 months
|
Hospital Anxiety and Depression Scale (HADS)
|
3 months
|
|
不安とうつ病
時間枠：6ヶ月
|
病院の不安とうつ病の尺度 (HADS)
|
6ヶ月
|
|
Fertility quality of life
時間枠：0 months
|
FertiQoL International Questionnaire
|
0 months
|
|
Fertility quality of life
時間枠：6 months
|
FertiQoL International Questionnaire
|
6 months
|
|
Depression
時間枠：0 months
|
Edinburgh Postnatal Depression Scale (EPDS) Questionnaire
|
0 months
|
|
Depression
時間枠：6 months
|
Edinburgh Postnatal Depression Scale (EPDS) Questionnaire
|
6 months
|
|
Self-determined motivation for physical activity
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：3 years
|
Number of pregnancy complications (gestational diabetes, pre-eclampsia, hypertension, fetal growth disorders, preterm birth)
|
3 years
|
|
Delivery complications
時間枠：3 years
|
Number of delivery complications (cesarean section, assisted vaginal delivery, hemorrhage)
|
3 years
|
|
Neonatal outcome
時間枠：3 years
|
Birth weight, cord pH, Apgar score
|
3 years
|
|
Body composition of the newborn
時間枠：At birth
|
Bioimpedance method
|
At birth
|
|
Growth of the child
時間枠：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
時間枠：0 months
|
Determination of heritable phenotype
|
0 months
|
|
Sperm epigenetic profile
時間枠：6 months
|
Determination of heritable phenotype
|
6 months
|
|
Transcriptome
時間枠：0 months
|
RNA-sequencing
|
0 months
|
|
Transcriptome
時間枠：6 months
|
RNA-sequencing
|
6 months
|
|
Sperm oxidative stress
時間枠：0 months
|
the Male infertility Oxidative System test (MiOXSYS)
|
0 months
|
|
Sperm oxidative stress
時間枠：6 months
|
the Male infertility Oxidative System test (MiOXSYS)
|
6 months
|
|
A cost-utility of the intervention
時間枠：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
時間枠：0 months
|
WHOQOL-BREF Questionnaire and FertiQoL International Questionnaire
|
0 months
|
|
QALY end point
時間枠：6 months
|
WHOQOL-BREF Questionnaire and FertiQoL International Questionnaire
|
6 months
|
|
Cost-effectiveness
時間枠：3 years
|
ICER
|
3 years
|
|
Static postural balance
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：0 months
|
Perceived Stress Scale by Sheldon Cohen
|
0 months
|
|
Perception of stress
時間枠：3 months
|
Perceived Stress Scale by Sheldon Cohen
|
3 months
|
|
Perception of stress
時間枠：6 months
|
Perceived Stress Scale by Sheldon Cohen
|
6 months
|
|
Personality dimensions
時間枠：0 months
|
The Big Five Personality Test
|
0 months
|
|
Personality dimensions
時間枠：6 months
|
The Big Five Personality Test
|
6 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Juha Tapanainen, professor、Helsinki University Central Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (予想される)
2021年10月1日
一次修了 (予想される)
2024年9月1日
研究の完了 (予想される)
2025年9月1日
試験登録日
最初に提出
2020年10月9日
QC基準を満たした最初の提出物
2020年10月9日
最初の投稿 (実際)
2020年10月19日
学習記録の更新
投稿された最後の更新 (実際)
2021年8月12日
QC基準を満たした最後の更新が送信されました
2021年8月6日
最終確認日
2021年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。