- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02490579
Effectiveness of Video Messaging About Diet, Exercise and Weight Gain in Pregnancy in Regional and National Samples
2016년 5월 20일 업데이트: Michelle H. Moniz, University of Michigan
The primary purpose of this study is to assess the responses of pregnant women and their social network to six videos about health in pregnancy.
Our goal is to assess a) acceptability and b) understanding of core messages about healthy eating, exercise and weight gain during pregnancy.
We will also assess c) non-clinical sources of health information during pregnancy.
연구 개요
상태
완전한
상세 설명
Many women engage in suboptimal lifestyle behaviors during pregnancy.
Many women do not realize that unhealthy diet, exercise and weight gain behaviors can be dangerous for their pregnancy and have harmful long-term consequences for their baby.
There is great need for strategies to promote accurate knowledge about healthy behaviors during pregnancy.
The purpose of this study is to assess responses to a brief (<1minute) video about healthy behaviors during pregnancy.
The study sample will include pregnant women and members of their social network.
Participants will be asked to watch a brief video and complete an anonymous online survey measuring their response to the video, and their basic demographics.
The surveys will also assess how family and friends impact pregnant women's health behaviors.
Online surveys are entirely anonymous.
We will recruit pregnant participants from two sources: the University of Michigan Health System's prenatal clinics and a social media website (Facebook).
연구 유형
관찰
등록 (실제)
1670
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- University of Michigan
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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
여성
샘플링 방법
비확률 샘플
연구 인구
Women recruited via either the social media, clinical, or online approach will be eligible for participation if they are aged 18 years and older, pregnant, and English-speaking.
Women will be excluded if they deny being currently pregnant, do not identify as living in the US and aged 18 years or older, or if they report having previously participated in the study.
The Qualtrics survey will automatically conclude if potential participants provide answers to screening questions that deem them ineligible.
Participants will not be excluded based on racial-ethnic groups.
Males will be excluded, as this is a study involving pregnant women.
설명
Inclusion Criteria:
- Women
- Currently Pregnant
- Age 18 or over
- English-speaking
Exclusion Criteria:
- Deny being currently pregnant
- Do not identify as living in the US and aged 18 years or older
- Report having previously participated in the study
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Facebook Survey Group
During June, 2015, approximately 1200 women will be recruited through Facebook advertisements targeted at English-speaking women age 18-50 years living in the United States.
Advertisements will contain 3 key features: an image, a caption, and "ad copy" followed by a link to the survey website.
Individuals who click on the study link in the advertisement will be redirected to the study's Qualtrics web page where they will take a 15 web-page, multiple choice survey developed by the research team.
The survey covers these domains: reaction to video, understanding of core message, self-efficacy around lifestyle behaviors, attitudes, beliefs and intentions regarding vaccination during pregnancy, key health information sources during pregnancy, and demographics.
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Participants view 1 of 6 brief video messages about health in pregnancy, then answer survey questions that will assess their a) acceptability, b) understanding of core messages, and c) self-efficacy about healthy eating, exercise and weight gain during pregnancy.
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Clinical Survey Group
During June-August, 2015, approximately 500 women will be recruited at routine obstetric visits to the University of Michigan's outpatient clinics.
Women who check in for an Ob appointment will be offered the opportunity to participate in an anonymous online survey.
Individuals who express interest in participating will be provided with a laptop and headphones and directed to the survey Qualtrics site where they will take a 15 web-page, multiple choice survey developed by the research team.
The survey covers these domains: reaction to video, understanding of core message, self-efficacy around lifestyle behaviors, attitudes, beliefs and intentions regarding vaccination during pregnancy, key health information sources during pregnancy, and demographics.
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Participants view 1 of 6 brief video messages about health in pregnancy, then answer survey questions that will assess their a) acceptability, b) understanding of core messages, and c) who in her social network she turns to for non-clinical health advice and what kinds of advice she gotten in the past.
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Social Network Group
Once a pregnant participant completes the survey, she will be asked to provide her email address.
If she is willing to do so, Qualtrics will automatically send her an email containing a weblink to the survey for her social network.
She can then provide this link to 1 or 2 social network members that she feels influence her health behaviors during pregnancy.
These members are asked similar questions about their response to the video, as well as some additional questions about how they advise their pregnant person about different health topics.
It is necessary to provide a unique weblink to her, so that the survey responses from the pregnant woman and her unique social network members can be linked.
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Participants view 1 of 6 brief video messages about health in pregnancy, then answer survey questions that will assess their a) acceptability, b) understanding of core messages, and c) how they advise their pregnant friend about different health topics.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Composite acceptability score (continuous variable)
기간: 15 minutes
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Participants will be asked questions about their reaction to the video.
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15 minutes
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Understanding of core messages (free text item; categorical items)
기간: 15 minutes
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Trained research assistants will review answers to questions regarding diet, exercise and weight gain in pregnancy to determine whether individuals understood/did not understand the core message.
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15 minutes
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Self-efficacy (continuous scale; Facebook group only)
기간: 15 minutes
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Participants will answer questions about self-efficacy regarding weight gain, exercise and diet.
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15 minutes
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Sources of information about health during pregnancy (categorical variable; clinic and social network groups only)
기간: 15 minutes
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Participants will answer questions about what sources of health information are provided by social network contacts during pregnancy.
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15 minutes
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Content of health information from interpersonal sources during pregnancy (free text variable; clinic and social network groups only)
기간: 15 minutes
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Trained research assistants will review answers to questions about the types of health information and advice are provided by social network contacts during pregnancy.
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15 minutes
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Perceived impact of interpersonal health advice on health behaviors during pregnancy (categorical and free text variables; clinic and social network groups only)
기간: 15 minutes
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Participants answer questions about the impact the health information and advice they receive from social network contacts during pregnancy has on their behavior.
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15 minutes
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Michelle H. Moniz, MD, University of Michigan
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
2015년 5월 1일
기본 완료 (실제)
2015년 9월 1일
연구 완료 (실제)
2015년 11월 1일
연구 등록 날짜
최초 제출
2015년 6월 29일
QC 기준을 충족하는 최초 제출
2015년 7월 6일
처음 게시됨 (추정)
2015년 7월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 5월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 5월 20일
마지막으로 확인됨
2016년 5월 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. .