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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02490579
Other study ID # HUM00101358
Secondary ID
Status Completed
Phase N/A
First received June 29, 2015
Last updated May 20, 2016
Start date May 2015
Est. completion date November 2015

Study information

Verified date May 2016
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

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


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).


Recruitment information / eligibility

Status Completed
Enrollment 1670
Est. completion date November 2015
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composite acceptability score (continuous variable) Participants will be asked questions about their reaction to the video. 15 minutes No
Primary 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 No
Primary Self-efficacy (continuous scale; Facebook group only) Participants will answer questions about self-efficacy regarding weight gain, exercise and diet. 15 minutes No
Primary 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 No
Primary 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 No
Primary 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 No
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