NCT06698133

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

November 18, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

November 18, 2024

Last Update Submit

March 26, 2025

Conditions

Keywords

Gestational Weight GainInfant Birth WeightHealth Literacy

Outcome Measures

Primary Outcomes (1)

  • 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 .

    All study participants will complete this survey at the beginning of the study and again after week 8.

Secondary Outcomes (1)

  • Demographic Information

    From enrollment to the end of 8 weeks

Other Outcomes (1)

  • 24-hour food recall tool

    The ASA24 will be completed 2x /week for 8 weeks.

Study Arms (2)

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.

Other: Participants in the intervention arm will be invited to join a private social media group

Interventions

Eligibility Criteria

Age13 Years - 19 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • History of diabetes
  • Current record of substance abuse
  • Mental impairment
  • Eating disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gestational Weight Gain

Condition Hierarchy (Ancestors)

Weight GainBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 18, 2024

First Posted

November 20, 2024

Study Start

April 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

April 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share