- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07620704
French Cross-cultural Adaptation of the Iowa Infant Feeding Attitude Scale (IIFAS) (FRENCH IIFAS)
French Cross-cultural Adaptation of the Iowa Infant Feeding Attitude Scale (IIFAS) and Assessments of Parental Representations of Infant Feeding During Pregnancy in the Auvergne Perinatal Network.
Our study will consist of two parts:
- Part 1: Cross-cultural adaptation of the Iowa Infant Feeding Attitude Scale (IIFAS) among postpartum mothers and co-parents in France and assessment of its psychometric properties
- Part 2: Assessment of cultural representations of infant feeding practices during pregnancy.
The goal of this repeated cross-sectional study is to cross-culturally adapt and evaluate the psychometric properties of the French version of the IIFAS among postpartum mothers in France.
In the part 1 of the study, the main questions it aims to answer are:
- Evaluation of the psychometric properties of the French version of the Iowa Infant Feeding Attitude Scale (IIFAS) among postpartum mothers in France
- Evaluation of the psychometric properties of the French version of the Iowa Infant Feeding Attitude Scale (IIFAS) among postpartum co-parents in France
Participants will be asked :
- to complete the study questionnaires, including the French version of the IIFAS questionnaire.
- to complete the French version of the IIFAS questionnaire a second time 7 days after their initial completion.
- to answer 1 to 4 questions about the infant's current feeding regimen 8 weeks after giving birth.
In the part 2, the goal of this descriptive cross-sectional study is to assess cultural representations of infant feeding practices during pregnancy among pregnant women in France during the first and the third trimesters.
In the part 2 of the study, the main questions it aims to answer are:
- To describe cultural perceptions of infant feeding practices among mothers in France during the first and third trimesters of pregnancy.
- To describe the cultural perceptions of infant feeding practices among co-parents in France during the first and third trimesters of pregnancy.
- To compare the cultural perceptions of infant feeding practices among mothers according to the trimester of pregnancy.
- To analyze the impact of different factors (age, education level, occupation, number of children, geographic origin, socioeconomic status, having been breastfed oneself, having personal experience with breastfeeding, plans to return to work, etc.) on mothers' cultural perceptions of infant feeding practices during the first and third trimesters of pregnancy.
- To compare co-parents' cultural perceptions of infant feeding methods according to the trimester of pregnancy.
- To analyze the impact of different factors (age, education level, occupation, number of children, geographic origin, socioeconomic status, having been breastfed oneself, having a child who was previously breastfed, etc.) on co-parents' cultural perceptions of infant feeding methods during the first and third trimesters of pregnancy.
- To compare the cultural perceptions of infant feeding practices between mothers and co-parents during the first and third trimesters of pregnancy.
Participants will be asked to complete the study questionnaires, including the French version of the IIFAS questionnaire.
연구 개요
상태
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Lise LACLAUTRE
- 전화번호: +33 +33473754963
- 이메일: promo_interne_drci@chu-clermontferrand.fr
연구 장소
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France
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Clermont-Ferrand, France, 프랑스, 63000
- CHU de Clermont-Ferrand
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수석 연구원:
- Chloé BARASIONSKI
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
For part 1, Our target population will consist of new parents during their stay in the maternity ward at one of the Auvergne Perinatal Network maternity participating in the study.
For part 2, our target population will be expectant parents during pregnancy who are receiving care within the Auvergne Perinatal Network. Participation by both parents is not required for this study.
설명
Part 1
Inclusion Criteria:
- Adult women hospitalized for postpartum care in one of the 10 maternity hospitals of the Auvergne perinatal network participating in the project, and/or adult co-parents whose partner is hospitalized in one of the 10 RSPA maternity hospitals participating in the project,
- Mothers and/or co-parents of a singleton child born alive at term (≥37 weeks' gestation) and hospitalized in the maternity ward,
- Mothers and/or co-parents of a child less than 6 days old,
- Mothers and/or co-parents affiliated to a social security scheme,
- Mothers and/or co-parents capable of reading and understanding French.
Non-inclusion Criteria:
- Mothers and/or co-parents of a child hospitalized outside the maternity ward,
- Mothers and/or co-parents who are adults with legal incapacity (under guardianship, conservatorship, or judicial protection),
- Mothers and/or co-parents who refuse to participate in the study,
- Mothers with a contraindication to AM and/or co-parents whose spouse has a contraindication to AM,
- Mothers and/or co-parents of a child with a medical condition or malformation that affects their feeding.
Part 2 during 1st trimester :
Inclusion Criteria:
- Pregnant adult women who are being cared for by healthcare professional belonging the Auvergne perinatal network and/or their co-parents of legal age, during the first trimester of pregnancy (before 16 weeks and 0 days of gestation),
- Pregnant women and/or co-parents affiliated to a social security scheme,
- Pregnant women and/or co-parents who can read and understand French.
Non-inclusion criteria :
- Pregnant women and/or co-parents in the second trimester of pregnancy (between 16 weeks 0 days and 28 weeks 6 days of gestation),
- Pregnant women and/or co-parents who are legally incapacitated adults (under guardianship, conservatorship, or judicial protection),
- Pregnant women and/or co-parents who refuse to participate in the study,
- Pregnant women with a contraindication to breastfeeding and/or co-parents whose partner has a contraindication to breastfeeding,
- Pregnant women with a multiple pregnancy and/or co-parents being monitored for a multiple pregnancy.
Part 2 during 3rd trimester :
Inclusion Criteria:
- Pregnant adult women who are being cared for by healthcare professional belonging the Auvergne perinatal network and/or their co-parents of legal age, during the third trimester of pregnancy (after 28 weeks and 6 days of gestation),
- Pregnant women and/or co-parents affiliated to a social security scheme,
- Pregnant women and/or co-parents who can read and understand French.
Non-inclusion criteria :
- Pregnant women and/or co-parents in the second trimester of pregnancy (between 16 weeks 0 days and 28 weeks 6 days of gestation),
- Pregnant women and/or co-parents who are legally incapacitated adults (under guardianship, conservatorship, or judicial protection),
- Pregnant women and/or co-parents who refuse to participate in the study,
- Pregnant women with a contraindication to breastfeeding and/or co-parents whose partner has a contraindication to breastfeeding,
- Women and/or co-parents of a child with a medical condition or malformation affecting the child's feeding,
- Pregnant women with a multiple pregnancy and/or co-parents being monitored for a multiple pregnancy.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Part 1 : Cross-cultural adaptation
196 mothers and 196 co-parents
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Part 2 : Cultural representations during 1st trimester
155 pregnant women and 155 co-parents in the first : 310 people in all
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Part 2 : Cultural representations during 3rd trimester
155 pregnant women and 155 co-parents in the third trimester of pregnancy: 310 people in all
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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French-IIFAS for mothers [Part 1]
기간: 0 day
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Psychometric properties (acceptability, floor effect, internal validity, internal consistency, construct validity) of the French version of the Iowa Infant Feeding Attitude Scale (IIFAS) among postpartum mothers in France
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0 day
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French-IIFAS scores for pregnant women [Part 2 1st trimester] [Part 2 3rd trimester]
기간: 0 day
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The item scores and total scores obtained by pregnant women at the first and third trimesters of pregnancy
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0 day
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change of French-IIFAS from baseline at 7 days for mothers [Part 1]
기간: 7 days
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Test-retest reliability of the French version of the IIFAS questionnaire among mothers
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7 days
|
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Predictive value of French-IIFAS among mothers [Part 1]
기간: 0 day, 8 weeks
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Predictive value of the score French-IIFAS questionnaire with the infant's feeding method at 8 weeks postpartum among mothers
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0 day, 8 weeks
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French-IIFAS for co-parents [Part 1]
기간: 0 day
|
Psychometric properties Psychometric properties (acceptability, floor effect, internal validity, internal consistency, construct validity) of the French version of the Iowa Infant Feeding Attitude Scale (IIFAS) among postpartum coparents in France
|
0 day
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Change of French-IIFAS from baseline at 7 days for coparents [Part 1]
기간: 0 day, 7 days
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Test-retest reliability of the French version of the IIFAS questionnaire among coparents
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0 day, 7 days
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Predictive value of French-IIFAS among coparents [Part 1]
기간: 0 day, 8 weeks
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Predictive value of the score French-IIFAS questionnaire with the infant's feeding method at 8 weeks postpartum among coparents
|
0 day, 8 weeks
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French-IIFAS scores for co-parents [Part 2 1st trimester] [Part 2 3rd trimester]
기간: 0 day
|
The item scores and total scores obtained by co-parents at the first and third trimesters of pregnancy
|
0 day
|
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Differences in French-IIFAS scores for pregnant women between the first and third trimesters of pregnancy [Part 2 1st trimester] [Part 2 3rd trimester]
기간: 0 day
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The item scores and total French-IIFAS questionnaire scores obtained by pregnant women will be compared between the first and third trimesters
|
0 day
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Differences in French-IIFAS scores for co-parents between the first and third trimesters of pregnancy [Part 2 1st trimester] [Part 2 3rd trimester]
기간: 0 day
|
The item scores and total French-IIFAS questionnaire scores obtained by the co-parents will be compared between the first and third trimesters
|
0 day
|
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Background, socio-demographic and medical characteristics of pregnant women [Part 2 1st trimester] [Part 2 3rd trimester]
기간: 0 day
|
Age, educational level, occupation, number of children, marital status, geographic origin, socioeconomic status, having been breastfed oneself, having personal experience with breastfeeding, having a child who has already been breastfed, optimal duration of breastfeeding, influence of the infant's feeding method on the couple's lifestyle, parent-child relationship, women's body image, plans to return to work after childbirth, intended feeding method.
|
0 day
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Background, socio-demographic and medical characteristics of co-parents [Part 2 1st trimester] [Part 2 3rd trimester]
기간: 0 day
|
Age, educational level, occupation, number of children, marital status, geographic origin, socioeconomic status, having been breastfed oneself, having personal experience with breastfeeding, having a child who has already been breastfed, optimal duration of breastfeeding, influence of the infant's feeding method on the couple's lifestyle, parent-child relationship, women's body image, plans to return to work after childbirth, intended feeding method.
|
0 day
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Differences in scores between mothers and co-parents [Part 2 1st trimester] [Part 2 3rd trimester]
기간: 0 day
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Item scores and the total score on the IIFAS questionnaire will be compared between mothers and co-parents during the first and third trimesters of pregnancy
|
0 day
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Chloé BARASINSKI, University Hospital, Clermont-Ferrand
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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