Prenatal Attitudes and Beliefs About HealthNCT01951014
Text for Prenatal Health Study
A study testing Social Media Education in people with Prenatal Attitudes and Beliefs About Health, run by Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Prenatal Attitudes and Beliefs About Health
- What is being tested?
- Social Media Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Oct 2014
- Phase
- Interventional
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rochester Adolescent Maternity Program Clinic
Rochester, New York, 14609
About this study
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.
Read the 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:
- Assess the impact of providing health information to pregnant adolescents (through Facebook and text messages) on fetal and maternal health outcomes across pregnancy.
- Assess maternal nutrition knowledge using a brief questionnaire before and after the social media intervention.
- Evaluate adolescent beliefs, attitudes and influences on dietary, physical activity, and life choices by asking teens to participate in interviews and focus groups.
- 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.
- Being tested
- Social Media Education
- Keywords
- Adolescence, Pregnancy, Telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Media EducationOther
Health messages provided via a private Facebook group and cellular text messages will be provided across gestation.
| Study group | Role | What they receive |
|---|---|---|
| Teen Social Media Education | Experimental | See description under intervention description Receives: Other: Social Media Education |
| Healthcare Provider Insights | No intervention | Healthcare providers providing care to pregnant adolescents will serve as key informants to provide an additional perspective for adolescent health beliefs and behaviors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescent health attitudes, beliefs, knowledge and behaviors
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.
Measured: Change from baseline in health beliefs and behaviors at 40 weeks
Secondary outcomes (1)
Healthcare provider views
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.
Measured: From date of enrollment, up to 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal Attitudes and Beliefs About HealthStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rochester
- Responsible party
- Sponsor
- Investigators
- Corrie Whisner, PhD, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951014
- Sponsor's protocol ID
- IRB #: 1308004041
- Other IDs
- 2012-67012-19815
- Status last verified
- Nov 2014
- First submitted
- 16 Sep 2013
- Last updated
- 17 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text for Prenatal Health Study
- ClinicalTrials.gov ID
- NCT01951014
- Acronym / sponsor ID
- IRB #: 1308004041
- Keywords
- Adolescence, Pregnancy, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- University of Rochester
- Study start
- Sep 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 26 Sep 2013 (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.
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:
- Assess the impact of providing health information to pregnant adolescents (through Facebook and text messages) on fetal and maternal health outcomes across pregnancy.
- Assess maternal nutrition knowledge using a brief questionnaire before and after the social media intervention.
- Evaluate adolescent beliefs, attitudes and influences on dietary, physical activity, and life choices by asking teens to participate in interviews and focus groups.
- 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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teen Social Media Education | Experimental | Other: Social Media EducationSee description under intervention description |
| Healthcare Provider Insights | No intervention | –Healthcare providers providing care to pregnant adolescents will serve as key informants to provide an additional perspective for adolescent health beliefs and behaviors. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Social Media EducationHealth messages provided via a private Facebook group and cellular text messages will be provided across gestation. | Other | Teen Social Media Education |
Primary outcome
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.
1 secondary outcome
Healthcare provider views
Time frame: From date of enrollment, up to 40 weeks
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 17 Nov 2014.
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.
Corrie Whisner, PhD principal investigator
Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Media Education in people with Prenatal Attitudes and Beliefs About Health, run by Cornell University 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 2 inclusion and 2 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 17 Nov 2014. 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?
Adolescent health attitudes, beliefs, knowledge and behaviors (time frame: Change from baseline in health beliefs and behaviors at 40 weeks). 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 17 Nov 2014.