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Text for Prenatal Health Study

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ClinicalTrials.gov Identifier: NCT01951014
Recruitment Status : Completed
First Posted : September 26, 2013
Last Update Posted : November 17, 2014
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Cornell University

Tracking Information
First Submitted Date  ICMJE September 16, 2013
First Posted Date  ICMJE September 26, 2013
Last Update Posted Date November 17, 2014
Study Start Date  ICMJE September 2013
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2013)
Adolescent health attitudes, beliefs, knowledge and behaviors [ Time Frame: Change from baseline in health beliefs and behaviors at 40 weeks ]
Teens will receive text messages from study staff and health information will be posted to a private Facebook group page. They will be able to interact with one another and discuss further the topics that are posted to their group page or that they have received via text message. Before they receive any of these messages, they will complete a baseline nutrition knowledge survey and participate in a focus group/interview. Midway through the study, teens will complete a survey about their digital media usage. Close to delivery, the teens will complete a second nutrition knowledge survey and participate in a final focus group/interview. All discussions will be related to diet, physical activity and general behaviors that teens engage in independently for prenatal care. All interviews and focus groups will be recorded so that transcripts can be made and common themes identified.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2013)
Healthcare provider views [ Time Frame: From date of enrollment, up to 40 weeks ]
Healthcare providers will be interviewed individually or in focus groups as key informants in order to gain a different view of pregnant adolescent health behaviors. Health professionals will complete a short demographic survey and participate in one interview in which they will be asked about general health advice they share with teens and how they perceive pregnant adolescent health behaviors. All interviews will be recorded so that transcripts can be made and common themes identified.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Text for Prenatal Health Study
Official Title  ICMJE Text for Prenatal Health Study
Brief Summary Currently little is known about the health beliefs and behaviors of pregnant adolescents. The goal of this pilot study is to educate pregnant adolescents via social media about nutrition and fitness during pregnancy and to evaluate their health beliefs and behaviors before and after receiving this information. Data collected will provide new information on which to base subsequent research and can be used to inform nutritional guidelines or public health programming for this vulnerable age group.
Detailed Description

The purpose of this pilot study is to find out if receiving electronic health information (e.g. text messages and Facebook posts) during pregnancy changes how pregnant teens think about their prenatal health and if fetal and maternal health outcomes can be improved. This study aims to:

  1. Assess the impact of providing health information to pregnant adolescents (through Facebook and text messages) on fetal and maternal health outcomes across pregnancy.
  2. Assess maternal nutrition knowledge using a brief questionnaire before and after the social media intervention.
  3. Evaluate adolescent beliefs, attitudes and influences on dietary, physical activity, and life choices by asking teens to participate in interviews and focus groups.
  4. Evaluate adolescent beliefs, attitudes and influences on dietary, physical activity and life choices through the perspective of healthcare providers by interviewing allied health workers at the adolescent pregnancy clinic.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Prenatal Attitudes and Beliefs About Health
Intervention  ICMJE Other: Social Media Education
Health messages provided via a private Facebook group and cellular text messages will be provided across gestation.
Study Arms  ICMJE
  • Experimental: Teen Social Media Education
    See description under intervention description
    Intervention: Other: Social Media Education
  • No Intervention: Healthcare Provider Insights
    Healthcare providers providing care to pregnant adolescents will serve as key informants to provide an additional perspective for adolescent health beliefs and behaviors.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2014)
30
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2013)
50
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • English speaking pregnant adolescents who have enrolled in the "Vitamin D Status Impacts Inflammation and Risk of Infections during Pregnancy" study (Clinical Trials ID: NCT01815047) and indicated interest on the consent form to participate in additional studies will be eligible to participate in this study. In order to participate, adolescents will have agreed to be contacted for future studies. Adolescents who are < 18 y, carrying a single fetus and between 12-30 weeks of gestation will be eligible to participate in this study.
  • Healthcare providers (> 18) who work at the adolescent maternity clinic and interact with pregnant adolescents will be eligible to participate in this study. This would include nurses, midwives, nutritionists, physicians, and social workers of all ages and genders.

Exclusion Criteria:

  • Exclusion criteria for this study include adolescent males and females who are not pregnant and do not speak English. Additionally, adolescents participants will be excluded if they have been diagnosed with eating disorders, malabsorption diseases, HIV infection, and diabetes (criteria outlined in parent study protocol; Clinical Trials ID: NCT01815047)
  • Healthcare providers who do not speak English will not be eligible to participate in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01951014
Other Study ID Numbers  ICMJE IRB #: 1308004041
2012-67012-19815 ( Other Identifier: NIFA )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cornell University
Study Sponsor  ICMJE Cornell University
Collaborators  ICMJE University of Rochester
Investigators  ICMJE
Principal Investigator: Corrie Whisner, PhD Cornell University
PRS Account Cornell University
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP