- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02490579
Effectiveness of Video Messaging About Diet, Exercise and Weight Gain in Pregnancy in Regional and National Samples
May 20, 2016 updated by: 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.
Study Overview
Status
Completed
Conditions
Detailed Description
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).
Study Type
Observational
Enrollment (Actual)
1670
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite acceptability score (continuous variable)
Time Frame: 15 minutes
|
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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michelle H. Moniz, MD, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
June 29, 2015
First Submitted That Met QC Criteria
July 6, 2015
First Posted (Estimate)
July 7, 2015
Study Record Updates
Last Update Posted (Estimate)
May 23, 2016
Last Update Submitted That Met QC Criteria
May 20, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00101358
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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