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- Klinische proef NCT02490579
Effectiveness of Video Messaging About Diet, Exercise and Weight Gain in Pregnancy in Regional and National Samples
20 mei 2016 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
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).
Studietype
Observationeel
Inschrijving (Werkelijk)
1670
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48109
- University of Michigan
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 50 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Composite acceptability score (continuous variable)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Michelle H. Moniz, MD, University of Michigan
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 mei 2015
Primaire voltooiing (Werkelijk)
1 september 2015
Studie voltooiing (Werkelijk)
1 november 2015
Studieregistratiedata
Eerst ingediend
29 juni 2015
Eerst ingediend dat voldeed aan de QC-criteria
6 juli 2015
Eerst geplaatst (Schatting)
7 juli 2015
Updates van studierecords
Laatste update geplaatst (Schatting)
23 mei 2016
Laatste update ingediend die voldeed aan QC-criteria
20 mei 2016
Laatst geverifieerd
1 mei 2016
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HUM00101358
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Nee
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .