Real-time Continuous Glucose Monitoring and Mobile-based Social Support to Promote Glucose Management During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Self-efficacy for glucose management
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group 1- Group chat intervention
Participants in group 1 will be randomized to wear a real-time continuous glucose monitor for 14 days and participate in a secure mobile-based group chat where they will provide and receive social support for glucose management. Participants will be in the group chat for 60 days.
干预措施: Mobile-based social support (Behavioral)
Group 1- Group chat intervention
Participants in group 1 will be randomized to wear a real-time continuous glucose monitor for 14 days and participate in a secure mobile-based group chat where they will provide and receive social support for glucose management. Participants will be in the group chat for 60 days.
干预措施: Real-time continuous glucose monitoring (Behavioral)
Group 2- No group chat intervention
Participants in group 2 will be randomized to wear a real-time continuous glucose monitor for 14 days.
干预措施: Real-time continuous glucose monitoring (Behavioral)
结局指标
主要结局
Self-efficacy for glucose management
时间窗: 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)
次要结局
- 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)
- Pre-natal care satisfaction(Baseline, Day 60 of study completion)
- Motivation for glucose management(Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 60 of study)
- Pregnancy-specific stress(Baseline, Day 60 of study participation)