Gestational Diabetes, Pregnancy, Complications
Conditions
Keywords
pregnancy, gestational diabetes, GDM, intervention, hyperglycemia, group chat, continuous glucose monitoring, mobile-based, behavioral change, CGM
Brief summary
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.
Interventions
BEHAVIORALMobile-based social support
Participants 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.
BEHAVIORALReal-time continuous glucose monitoring
Participants 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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants will be randomly assigned to one of two groups. Group 1 will receive real-time continuous glucose monitoring plus mobile-based social support. Group 2 will only receive real-time continuous glucose monitoring.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Own a smartphone and willing to use the CGM app and Signal * Receiving prenatal care and planning to deliver at Tufts Medicine (Boston) * Signed the consent form * Currently located in the United States
Exclusion criteria
* 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 * Current history of heroin, cocaine, crack, LSD, or methamphetamines * Current history of alcohol abuse * Previous gastric bypass * Shift work that alters the sleep/wake periods * Have known rheumatological or chronic inflammatory state (i.e., arthritis, inflammatory bowel disease)? * Chronic illnesses, including diabetes and dialysis, that require regular medication use * Uncontrolled hypothyroidism * Known culture of positive chorioamnionitis? * An adult who is unable to consent (e.g., cognitively impaired adults) * Ward of the state * Unable to read or write English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-efficacy for glucose management | Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 60 of study | Self-efficacy will be adapted from a validated survey of self-efficacy for type II diabetes management (DMSES UK) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motivation for glucose management | Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 60 of study | Assessed using items from the Treatment Self-Regulation Questionnaire (TSRQ) |
| Pregnancy-specific stress | Baseline, Day 60 of study participation | Pregnancy-specific stress will be measured (via questionnaire) using a validated scale that was empirically associated with birth outcomes |
| Social support | Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 30 of group chat participation, Day 60 of study participation | 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) |
| Pre-natal care satisfaction | Baseline, Day 60 of study completion | 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. |
Countries
United States
Contacts
Primary ContactLarissa Calancie, PhD
Outcome results
None listed