PregnancyNCT02490579
Effectiveness of Video Messaging About Diet, Exercise and Weight Gain in Pregnancy in Regional and National Samples
An observational study of Pregnancy and Weight Gain, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Weight Gain
- What is being tested?
- Responses to Brief Video Messages (Facebook), Response to Brief Video Messages (Clinic) and Response to Brief Video Messages (Social Network)
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- How many people
- 1,670 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Women
- Currently Pregnant
- Age 18 or over
- English-speaking
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Pregnancy, Weight Gain
- Being tested
- Responses to Brief Video Messages (Facebook), Response to Brief Video Messages (Clinic), Response to Brief Video Messages (Social Network)
- Keywords
- video messaging, exercise, diet, weight gain, pregnancy
- Medical subject headings
- Weight Gain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Responses to Brief Video Messages (Facebook)Behavioural
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.
Response to Brief Video Messages (Clinic)Behavioural
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.
Response to Brief Video Messages (Social Network)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Responses to Brief Video Messages (Facebook) | |
| 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. Receives: Behavioral: Response to Brief Video Messages (Clinic) | |
| 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. Receives: Behavioral: Response to Brief Video Messages (Social Network) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite acceptability score (continuous variable)
Participants will be asked questions about their reaction to the video.
Measured: 15 minutes
Understanding of core messages (free text item; categorical items)
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.
Measured: 15 minutes
Self-efficacy (continuous scale; Facebook group only)
Participants will answer questions about self-efficacy regarding weight gain, exercise and diet.
Measured: 15 minutes
Sources of information about health during pregnancy (categorical variable; clinic and social network groups only)
Participants will answer questions about what sources of health information are provided by social network contacts during pregnancy.
Measured: 15 minutes
Content of health information from interpersonal sources during pregnancy (free text variable; clinic and social network groups only)
Trained research assistants will review answers to questions about the types of health information and advice are provided by social network contacts during pregnancy.
Measured: 15 minutes
Perceived impact of interpersonal health advice on health behaviors during pregnancy (categorical and free text variables; clinic and social network groups only)
Participants answer questions about the impact the health information and advice they receive from social network contacts during pregnancy has on their behavior.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,670 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle H. Moniz, University of Michigan
- Investigators
- Michelle H. Moniz, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490579
- Sponsor's protocol ID
- HUM00101358
- Status last verified
- May 2016
- First submitted
- 29 Jun 2015
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Video Messaging About Diet, Exercise and Weight Gain in Pregnancy in Regional and National Samples
- ClinicalTrials.gov ID
- NCT02490579
- Acronym / sponsor ID
- HUM00101358
- Conditions
- Pregnancy, Weight Gain
- Keywords
- video messaging, exercise, diet, weight gain, pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,670 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 7 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Facebook Survey Group | – | Behavioral: Responses to Brief Video Messages (Facebook)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. |
| Clinical Survey Group | – | Behavioral: Response to Brief Video Messages (Clinic)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. |
| Social Network Group | – | Behavioral: Response to Brief Video Messages (Social Network)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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- Women
- Currently Pregnant
- Age 18 or over
- English-speaking
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Responses to Brief Video Messages (Facebook)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. | Behavioural | Facebook Survey Group |
| Response to Brief Video Messages (Clinic)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. | Behavioural | Clinical Survey Group |
| Response to Brief Video Messages (Social Network)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. | Behavioural | Social Network Group |
Primary outcome
Composite acceptability score (continuous variable)
Time frame: 15 minutes
Participants will be asked questions about their reaction to the video.
Understanding of core messages (free text item; categorical items)
Time frame: 15 minutes
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.
Self-efficacy (continuous scale; Facebook group only)
Time frame: 15 minutes
Participants will answer questions about self-efficacy regarding weight gain, exercise and diet.
Sources of information about health during pregnancy (categorical variable; clinic and social network groups only)
Time frame: 15 minutes
Participants will answer questions about what sources of health information are provided by social network contacts during pregnancy.
Content of health information from interpersonal sources during pregnancy (free text variable; clinic and social network groups only)
Time frame: 15 minutes
Trained research assistants will review answers to questions about the types of health information and advice are provided by social network contacts during pregnancy.
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
Participants answer questions about the impact the health information and advice they receive from social network contacts during pregnancy has on their behavior.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle H. Moniz, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Weight Gain, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite acceptability score (continuous variable) (time frame: 15 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2016.