NCT02490579

Brief 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. We will also assess c) non-clinical sources of health information during pregnancy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,670

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 7, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

May 23, 2016

Status Verified

May 1, 2016

Enrollment Period

4 months

First QC Date

June 29, 2015

Last Update Submit

May 20, 2016

Conditions

Keywords

video messagingexercisedietweight gainpregnancy

Outcome Measures

Primary Outcomes (6)

  • Composite acceptability score (continuous variable)

    Participants will be asked questions about their reaction to the video.

    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.

    15 minutes

  • Self-efficacy (continuous scale; Facebook group only)

    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)

    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)

    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)

    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

Study Arms (3)

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)

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)

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)

Interventions

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.

Facebook Survey Group

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.

Clinical Survey Group

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.

Social Network Group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Women
  • Currently Pregnant
  • Age 18 or over
  • English-speaking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Weight GainMotor Activity

Interventions

Ambulatory Care Facilities

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Health FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Michelle H. Moniz, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 29, 2015

First Posted

July 7, 2015

Study Start

May 1, 2015

Primary Completion

September 1, 2015

Study Completion

November 1, 2015

Last Updated

May 23, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations