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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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.
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.
Behavioral: 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.
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
15 minutes
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.
15 minutes
Self-efficacy (continuous scale; Facebook group only)
Time Frame: 15 minutes
Participants will answer questions about self-efficacy regarding weight gain, exercise and diet.
15 minutes
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.
15 minutes
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.
15 minutes
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.
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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