Glucose Empowerment Through Monitoring and Social Support in Pregnancy
- Conditions
- Pregnancy, ComplicationsGestational Diabetes
- Registration Number
- NCT07009704
- Lead Sponsor
- Tufts Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 70
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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".
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