Glucose Empowerment Through Monitoring and Social Support in Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorTufts Medical Center
About this trial
The purpose of the research is to learn whether wearing a continuous glucose monitor that shows blood glucose levels in real time on a smart phone app and participating in a group chat with other research participants will help participants keep a healthy blood glucose level during pregnancy.
High levels of blood glucose during pregnancy can lead to health problems during and after pregnancy. It may also increase the risk for health problems for the developing baby.
The investigators think our program might be a new way to help some people maintain a healthy blood glucose level during pregnancy. When pregnant people know their blood glucose levels are high, they can do things like exercise or drink water to bring their blood glucose levels down. They can also learn what foods to eat to maintain healthy blood glucose levels, and what foods to avoid. The investigators think being in a group chat with other pregnant individuals will allow participants to support and learn from each other. Pregnant individuals should also work with their healthcare providers to manage their blood glucose levels.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant (<20w0d)
At least 18 years to 45 years old
BMI >25, personal history of GDM, or first-degree family member with type II diabetes
Comfortable conversing in English
Disqualifiers
Current pregnancy a multiple gestation (e.g., twins)
Smoked during this current pregnancy
Active hepatitis or HIV infection
Current pregnancy have any documented fetal congenital anomalies
Trial design
Design model
Parallel
Treatments tested in this trial
Mobile-based social support
BehavioralParticipants will be invited to join an encrypted group chat where they will be encouraged to provide and receive social support related to glucose management during early pregnancy. Other study participants and study team members will be in the group chat.
Real-time continuous glucose monitoring
BehavioralParticipants will receive a real-time continuous glucose monitor that pairs with an existing smartphone app that shows minute-by-minute glucose levels and records glucose levels in 5 minute increments.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Group 1- Group chat interventionExperimental treatment 2 interventions
Group B: Group 2- No group chat interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Self-efficacy for glucose management
Self-efficacy will be adapted from a validated survey of self-efficacy for type II diabetes management (DMSES UK)
Time frame
Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 60 of studySecondary outcomes
1
Motivation for glucose management
Assessed using items from the Treatment Self-Regulation Questionnaire (TSRQ)
Time frame
Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 60 of study2
Pregnancy-specific stress
Pregnancy-specific stress will be measured (via questionnaire) using a validated scale that was empirically associated with birth outcomes
Time frame
Baseline, Day 60 of study participation3
Social support
A social support survey was adapted from the validated Inventory of Socially Supportive Behaviors (ISSB) that assess multiple subtypes of social support (emotional, informational, instrumental/tangible, belonging, appraisal)
Time frame
Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 30 of group chat participation, Day 60 of study participation4
Pre-natal care satisfaction
Prenatal care satisfaction will be assessed using a combination of questions from Raube and colleague's validated questionnaire and the Mother's Autonomy in Decision Making (MADM) scale. The combination of questionnaires is scored as "Excellent, Good, Average, Poor, N/A".
Time frame
Baseline, Day 60 of study completionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tufts Medical Center
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov