COaching Lifestyle Intervention for FErtility (COLIFE)
2021년 8월 6일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (예상)
1560
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Maritta Poyhonen-Alho, PhD
- 전화번호: +358 50 428 4690
- 이메일: maritta.poyhonen-alho@hus.fi
연구 연락처 백업
- 이름: Paivi Joki-Korpela, PhD
- 전화번호: +358
- 이메일: paivi.joki-korpela@hus.fi
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: 제어
기존의 치료
|
|
|
활성 비교기: Intervention
Motivational interview
|
Life Style intervention including physical activity, diet, sleep and stress
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Behavior change
기간: 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
기간: 3 years
|
Number of live children born
|
3 years
|
|
Weight change
기간: 6 months
|
weight in kg measured without shoes and with light clothing at the beginning, at 3 and 6 months
|
6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Infertility treatments, number
기간: 3 years
|
Number of infertility treatments needed for a live birth
|
3 years
|
|
Infertility treatments, mode
기간: 3 years
|
Mode of infertility treatments needed for a live birth (including ovulation induction, insemination, IVF, ICSI)
|
3 years
|
|
Miscarriage rate
기간: 3 years
|
Number of miscarriages
|
3 years
|
|
Height
기간: 0 months
|
Measured without shoes (cm)
|
0 months
|
|
Weight
기간: 0 months
|
Measured without shoes and with light clothing (kg)
|
0 months
|
|
Weight
기간: 3 months
|
Measured without shoes and with light clothing (kg)
|
3 months
|
|
Weight
기간: 6 months
|
Measured without shoes and with light clothing (kg)
|
6 months
|
|
Body mass index
기간: 0 months
|
Weight in kilograms divided by the square of height in meters
|
0 months
|
|
Body mass index
기간: 3 months
|
Weight in kilograms divided by the square of height in meters
|
3 months
|
|
Body mass index
기간: 6 months
|
Weight in kilograms divided by the square of height in meters
|
6 months
|
|
Body composition
기간: 0 months
|
Bioimpedance method
|
0 months
|
|
Body composition
기간: 3 months
|
Bioimpedance method
|
3 months
|
|
Body composition
기간: 6 months
|
Bioimpedance method
|
6 months
|
|
Waist circumference
기간: 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
기간: 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
기간: 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
기간: 0 months
|
Minutes per week, International Physical Activity Questionnaire - Short Form
|
0 months
|
|
Self-reported physical activity
기간: 6 months
|
Minutes per week, International Physical Activity Questionnaire - Short Form
|
6 months
|
|
Physical activity
기간: 0 months
|
Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
|
0 months
|
|
Physical activity
기간: 3 months
|
Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
|
3 months
|
|
Physical activity
기간: 6 months
|
Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
|
6 months
|
|
Maximal oxygen uptake
기간: 0 months
|
Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
|
0 months
|
|
Maximal oxygen uptake
기간: 3 months
|
Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
|
3 months
|
|
Maximal oxygen uptake
기간: 6 months
|
Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
|
6 months
|
|
Dietary content
기간: 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
기간: 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
기간: 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
기간: 6 months
|
FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)
|
6 months
|
|
Folate
기간: 0 months
|
Plasma folate concentration
|
0 months
|
|
Folate
기간: 6 months
|
Plasma folate concentration
|
6 months
|
|
Vitamin-D
기간: 0 months
|
Plasma vitamin-D concentration
|
0 months
|
|
Vitamin-D
기간: 6 months
|
Plasma vitamin-D concentration
|
6 months
|
|
Zinc
기간: 0 months
|
Plasma zinc concentration
|
0 months
|
|
Zinc
기간: 6 months
|
Plasma zinc concentration
|
6 months
|
|
Carbohydrates
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 0 months
|
Quality of sleep, Basic Nordic Sleep Questionnaire (BNSQ)
|
0 months
|
|
Sleep
기간: 6 months
|
Quality of sleep, Basic Nordic Sleep Questionnaire (BNSQ)
|
6 months
|
|
Sleep, measured
기간: 0 months
|
Quality, sleep disruptions, total sleep duration registered by Oura ring application
|
0 months
|
|
Sleep, measured
기간: 3 months
|
Quality, sleep disruptions, total sleep duration registered by Oura ring application
|
3 months
|
|
Sleep, measured
기간: 6 months
|
Quality, sleep disruptions, total sleep duration registered by Oura ring application
|
6 months
|
|
Stress recovery
기간: 0 months
|
Night-time heart rate variability regisered by Oura ring application
|
0 months
|
|
Stress recovery
기간: 3 months
|
Night-time heart rate variability registered by Oura ring application
|
3 months
|
|
Stress recovery
기간: 6 months
|
Night-time heart rate variability registered by Oura ring application
|
6 months
|
|
Anxiety and depression
기간: 0 months
|
Hospital Anxiety and Depression Scale (HADS)
|
0 months
|
|
Anxiety and depression
기간: 3 months
|
Hospital Anxiety and Depression Scale (HADS)
|
3 months
|
|
불안과 우울증
기간: 6 개월
|
병원 불안 및 우울 척도(HADS)
|
6 개월
|
|
Fertility quality of life
기간: 0 months
|
FertiQoL International Questionnaire
|
0 months
|
|
Fertility quality of life
기간: 6 months
|
FertiQoL International Questionnaire
|
6 months
|
|
Depression
기간: 0 months
|
Edinburgh Postnatal Depression Scale (EPDS) Questionnaire
|
0 months
|
|
Depression
기간: 6 months
|
Edinburgh Postnatal Depression Scale (EPDS) Questionnaire
|
6 months
|
|
Self-determined motivation for physical activity
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 3 years
|
Number of pregnancy complications (gestational diabetes, pre-eclampsia, hypertension, fetal growth disorders, preterm birth)
|
3 years
|
|
Delivery complications
기간: 3 years
|
Number of delivery complications (cesarean section, assisted vaginal delivery, hemorrhage)
|
3 years
|
|
Neonatal outcome
기간: 3 years
|
Birth weight, cord pH, Apgar score
|
3 years
|
|
Body composition of the newborn
기간: At birth
|
Bioimpedance method
|
At birth
|
|
Growth of the child
기간: 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
기간: 0 months
|
Determination of heritable phenotype
|
0 months
|
|
Sperm epigenetic profile
기간: 6 months
|
Determination of heritable phenotype
|
6 months
|
|
Transcriptome
기간: 0 months
|
RNA-sequencing
|
0 months
|
|
Transcriptome
기간: 6 months
|
RNA-sequencing
|
6 months
|
|
Sperm oxidative stress
기간: 0 months
|
the Male infertility Oxidative System test (MiOXSYS)
|
0 months
|
|
Sperm oxidative stress
기간: 6 months
|
the Male infertility Oxidative System test (MiOXSYS)
|
6 months
|
|
A cost-utility of the intervention
기간: 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
기간: 0 months
|
WHOQOL-BREF Questionnaire and FertiQoL International Questionnaire
|
0 months
|
|
QALY end point
기간: 6 months
|
WHOQOL-BREF Questionnaire and FertiQoL International Questionnaire
|
6 months
|
|
Cost-effectiveness
기간: 3 years
|
ICER
|
3 years
|
|
Static postural balance
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 0 months
|
Perceived Stress Scale by Sheldon Cohen
|
0 months
|
|
Perception of stress
기간: 3 months
|
Perceived Stress Scale by Sheldon Cohen
|
3 months
|
|
Perception of stress
기간: 6 months
|
Perceived Stress Scale by Sheldon Cohen
|
6 months
|
|
Personality dimensions
기간: 0 months
|
The Big Five Personality Test
|
0 months
|
|
Personality dimensions
기간: 6 months
|
The Big Five Personality Test
|
6 months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Juha Tapanainen, professor, Helsinki University Central Hospital
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (예상)
2021년 10월 1일
기본 완료 (예상)
2024년 9월 1일
연구 완료 (예상)
2025년 9월 1일
연구 등록 날짜
최초 제출
2020년 10월 9일
QC 기준을 충족하는 최초 제출
2020년 10월 9일
처음 게시됨 (실제)
2020년 10월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 8월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 8월 6일
마지막으로 확인됨
2021년 8월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
불임 장애에 대한 임상 시험
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Jordi Zaragoza아직 모집하지 않음
Life Style에 대한 임상 시험
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Universidad Miguel Hernandez de Elche모집하지 않고 적극적으로
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University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)완전한정신 분열증 | 분열정동 장애 | 정신 분열증 장애 | 상세불명의 정신분열증 스펙트럼 및 기타 정신병적 장애 | 단기 정신병적 장애미국
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University of Illinois at ChicagoNational Institute on Minority Health and Health Disparities (NIMHD)완전한
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Montefiore Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)완전한
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University Hospital, Strasbourg, France종료됨당뇨병 환자(유형 1,2, MODY, 속발성) 또는 코르티코스테로이드 치료 개시 후 코르티코스테로이드 유발 당뇨병이 있는 환자프랑스
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The Hong Kong Polytechnic University모병