- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02490579
Effectiveness of Video Messaging About Diet, Exercise and Weight Gain in Pregnancy in Regional and National Samples
20. května 2016 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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).
Typ studie
Pozorovací
Zápis (Aktuální)
1670
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48109
- University of Michigan
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 50 let (Dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Ženský
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
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.
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Observační modely: Kohorta
- Časové perspektivy: Budoucí
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
---|---|
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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Composite acceptability score (continuous variable)
Časové okno: 15 minutes
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Participants will be asked questions about their reaction to the video.
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15 minutes
|
Understanding of core messages (free text item; categorical items)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
Content of health information from interpersonal sources during pregnancy (free text variable; clinic and social network groups only)
Časové okno: 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
|
Perceived impact of interpersonal health advice on health behaviors during pregnancy (categorical and free text variables; clinic and social network groups only)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Michelle H. Moniz, MD, University of Michigan
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. května 2015
Primární dokončení (Aktuální)
1. září 2015
Dokončení studie (Aktuální)
1. listopadu 2015
Termíny zápisu do studia
První předloženo
29. června 2015
První předloženo, které splnilo kritéria kontroly kvality
6. července 2015
První zveřejněno (Odhad)
7. července 2015
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
23. května 2016
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
20. května 2016
Naposledy ověřeno
1. května 2016
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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produkt vyrobený a vyvážený z USA
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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .