Teen PregnancyKnowTeensNCT06698133
Knowledge and Habits of Pregnant Teens
A study testing Participants in the intervention arm will be invited to join a private social media group in people with Teen Pregnancy, run by University of Mississippi Medical Center.
Trial summary
This study examines the link between health literacy, gestational weight gain, and infant birthweight in pregnant teenagers. A randomized trial of 50 participants will be conducted at the University of Mississippi Medical Center. Consent will be obtained from all participants. Read more about this study
- Who is it for?
- Ages 13 to 19 years, women only
- Conditions the study is for
- Teen Pregnancy
- What is being tested?
- Participants in the intervention arm will be invited to join a private social media group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Maternal age 13 - 19 yrs at enrollment
- < 19.6 gestational weeks
- Ability to understand English
- Access to a smartphone or internet
- Willingness to follow study procedures
- Plan to deliver at UMMC
- Singleton pregnancy
Who cannot join
- Does not meet the inclusion criteria
- History of diabetes
- Current record of substance abuse
- Mental impairment
- Eating disorder
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Knowledge and Habits of Pregnant Teens: Analyzing Nutritional Status, Weight and Infant Birth Weight
This study examines the link between health literacy, gestational weight gain, and infant birthweight in pregnant teenagers. A randomized trial of 50 participants will be conducted at the University of Mississippi Medical Center. Consent will be obtained from all participants. Both control and intervention groups will complete a 20 questions health literacy assessment at baseline and after eight weeks, along with the ASA24 dietary recall tool twice weekly. The intervention group will join a private social media group created solely for study purposes. This will be a private account, accessible only to participants who are added or invited by the study team.
Read the detailed description
This research study is to see if someone's ability to understand and use health information (health literacy) is linked to gaining a healthy amount of weight during pregnancy and having a baby with a healthy birth weight. The main question aims to answer if there is a positive correlation between increased health literacy, gestational weight gain, and adequate infant birth weight. We are conducting a prospective randomized trial involving 50 pregnant teenagers and their baby at a single institution. We will obtain study consent for 18 and 19 years old, and parental permission and assent for 13 -17 years old.
Control Group will complete the 20 questions health literacy during the first visit and after 8 weeks. Also, will complete the online called ASA 24 a 24-hour food recall tool. The ASA24 will be completed 2x /week for 8 weeks.
Intervention Group will complete the 20 questions health literacy during the first visit and after 8 weeks. Also, will complete the online called ASA 24 a 24-hour food recall tool. The ASA24 will be completed 2x /week for 8 weeks. In addition, participants assigned to the intervention group will be invited to participate in a private social media group. Participants will create a new account specifically for the study, or the study team can create an account on their behalf if they prefer. This will enable the study team to track participation without affecting any personal accounts. Education content will consist of published dietary recommendations during pregnancy, healthy craving hacks, healthy snacks, ways to get exercise in during the school day, etc. Participants will also be encouraged to ask questions and post any eating struggles.
- Conditions
- Teen Pregnancy
- Being tested
- Participants in the intervention arm will be invited to join a private social media group
- Keywords
- Gestational Weight Gain, Infant Birth Weight, Health Literacy
- Medical subject headings
- Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants in the intervention arm will be invited to join a private social media groupOther
Education content
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Control Group will complete the 20 questions health literacy during the first visit and after 8 weeks. Also, will complete the online called ASA 24 a 24-hour food recall tool. The ASA24 will be completed 2x /week for 8 weeks. |
| Intervention Arm | Experimental | Intervention Group will complete the 20 questions health literacy during the first visit and after 8 weeks. Also, will complete the online called ASA 24 a 24-hour food recall tool. The ASA24 will be completed 2x /week for 8 weeks. In addition, participants assigned to the intervention group will be invited to participate in a private social media group.
Participants in the intervention arm will be invited to join a private social media group that will be created solely for this study. This will be a private account, accessible only to participants who are added or invited by the study team. Receives: Other: Participants in the intervention arm will be invited to join a private social media group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Literacy
All data collected in the study design will be used to answer questions in this aim. The Maternal Health Literacy (MaHeLi) is a 20-item questionnaire used to assess health literacy in adolescents .
Measured: All study participants will complete this survey at the beginning of the study and again after week 8.
Secondary outcomes (1)
Demographic Information
Demographic information will be collected, such as maternal age, gender, race, pre-pregnancy body mass index, weight, height, and BMI. Obstetrical and medical history will also be collected but not limited to gestational age, historical and current maternal outcome. Infant data will also be collected, such as gender, birth weight, infant unit admission, and infant outcome.
Measured: From enrollment to the end of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Apr 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teen PregnancyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants in the intervention arm will be invited to join a private social media group that will be created solely for this study. Education content will consist of published dietary recommendations during pregnancy, healthy craving hacks, healthy snacks, ways to get exercise in during the school day, etc. Participants will also be encouraged to ask questions and post any eating struggles. The intervention will be completely virtual and outside of the initial visit. Medical advice will not be given; if requested, participants will be advised to contact their provider.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheila Belk, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698133
- Sponsor's protocol ID
- UMMC IRB 2024-447
- Other IDs
- pending
- Acronym
- KnowTeens
- Status last verified
- Mar 2025
- First submitted
- 18 Nov 2024
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge and Habits of Pregnant Teens: Analyzing Nutritional Status, Weight and Infant Birth Weight
- ClinicalTrials.gov ID
- NCT06698133
- Acronym / sponsor ID
- KnowTeens / UMMC IRB 2024-447
- Conditions
- Teen Pregnancy
- Keywords
- Gestational Weight Gain, Infant Birth Weight, Health Literacy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 Nov 2024 (actual)
- 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.
This study examines the link between health literacy, gestational weight gain, and infant birthweight in pregnant teenagers. A randomized trial of 50 participants will be conducted at the University of Mississippi Medical Center. Consent will be obtained from all participants. Both control and intervention groups will complete a 20 questions health literacy assessment at baseline and after eight weeks, along with the ASA24 dietary recall tool twice weekly. The intervention group will join a private social media group created solely for study purposes. This will be a private account, accessible only to participants who are added or invited by the study team.
Detailed description
This research study is to see if someone's ability to understand and use health information (health literacy) is linked to gaining a healthy amount of weight during pregnancy and having a baby with a healthy birth weight. The main question aims to answer if there is a positive correlation between increased health literacy, gestational weight gain, and adequate infant birth weight. We are conducting a prospective randomized trial involving 50 pregnant teenagers and their baby at a single institution. We will obtain study consent for 18 and 19 years old, and parental permission and assent for 13 -17 years old.
Control Group will complete the 20 questions health literacy during the first visit and after 8 weeks. Also, will complete the online called ASA 24 a 24-hour food recall tool. The ASA24 will be completed 2x /week for 8 weeks.
Intervention Group will complete the 20 questions health literacy during the first visit and after 8 weeks. Also, will complete the online called ASA 24 a 24-hour food recall tool. The ASA24 will be completed 2x /week for 8 weeks. In addition, participants assigned to the intervention group will be invited to participate in a private social media group. Participants will create a new account specifically for the study, or the study team can create an account on their behalf if they prefer. This will enable the study team to track participation without affecting any personal accounts. Education content will consist of published dietary recommendations during pregnancy, healthy craving hacks, healthy snacks, ways to get exercise in during the school day, etc. Participants will also be encouraged to ask questions and post any eating struggles.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants in the intervention arm will be invited to join a private social media group that will be created solely for this study. Education content will consist of published dietary recommendations during pregnancy, healthy craving hacks, healthy snacks, ways to get exercise in during the school day, etc. Participants will also be encouraged to ask questions and post any eating struggles. The intervention will be completely virtual and outside of the initial visit. Medical advice will not be given; if requested, participants will be advised to contact their provider.
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Control Group will complete the 20 questions health literacy during the first visit and after 8 weeks. Also, will complete the online called ASA 24 a 24-hour food recall tool. The ASA24 will be completed 2x /week for 8 weeks. |
| Intervention Arm | Experimental | Other: Participants in the intervention arm will be invited to join a private social media groupIntervention Group will complete the 20 questions health literacy during the first visit and after 8 weeks. Also, will complete the online called ASA 24 a 24-hour food recall tool. The ASA24 will be completed 2x /week for 8 weeks. In addition, participants assigned to the intervention group will be invited to participate in a private social media group. Participants in the intervention arm will be invited to join a private social media group that will be created solely for this study. This will be a private account, accessible only to participants who are added or invited by the study team. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Maternal age 13 - 19 yrs at enrollment
- < 19.6 gestational weeks
- Ability to understand English
- Access to a smartphone or internet
- Willingness to follow study procedures
Key exclusion criteria (5 listed)
- Does not meet the inclusion criteria
- History of diabetes
- Current record of substance abuse
- Mental impairment
- Eating disorder
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 |
|---|---|---|
| Participants in the intervention arm will be invited to join a private social media groupEducation content | Other | Intervention Arm |
Primary outcome
Health Literacy
Time frame: All study participants will complete this survey at the beginning of the study and again after week 8.
All data collected in the study design will be used to answer questions in this aim. The Maternal Health Literacy (MaHeLi) is a 20-item questionnaire used to assess health literacy in adolescents .
1 secondary outcome
Demographic Information
Time frame: From enrollment to the end of 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Teen Pregnancy
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
Active, not recruitingPhase 3
A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)
Chronic Kidney Disease
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingPhase 3
A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
Focal Segmental Glomerulosclerosis
Recruiting
AYAHIV Role-based Responsibilities for Oncology-focused Workforce (ARROW)
Cervical Cancer, Kaposi Sarcoma
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.
Questions about this trial
What is this clinical trial studying?
A study testing Participants in the intervention arm will be invited to join a private social media group in people with Teen Pregnancy, run by University of Mississippi Medical Center.
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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheila Belk (+1 (601) 984 -1690, sbelk@umc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Literacy (time frame: All study participants will complete this survey at the beginning of the study and again after week 8.). 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 1 Apr 2025.