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| ID | Type | Description | Link |
|---|---|---|---|
| K12HD092535 | U.S. NIH Grant/Contract | View source | |
| K12AR084217 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1- Group chat intervention | Experimental | 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. |
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| Group 2- No group chat intervention | Experimental | Participants in group 2 will be randomized to wear a real-time continuous glucose monitor for 14 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile-based social support | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-efficacy for glucose management | Self-efficacy will be adapted from a validated survey of self-efficacy for type II diabetes management (DMSES UK) | Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 60 of study |
| Measure | Description | Time Frame |
|---|---|---|
| Motivation for glucose management | Assessed using items from the Treatment Self-Regulation Questionnaire (TSRQ) | Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 60 of study |
| Pregnancy-specific stress |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Larissa Calancie, PhD | Contact | (617) 636-0976 | larissa.calancie@tufts.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Recruiting | Boston | Massachusetts | 02111 | United States |
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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D016640 | Diabetes, Gestational |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
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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.
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| Real-time continuous glucose monitoring | Behavioral | 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. |
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Pregnancy-specific stress will be measured (via questionnaire) using a validated scale that was empirically associated with birth outcomes
| Baseline, Day 60 of study participation |
| 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) | 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 | 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". | Baseline, Day 60 of study completion |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |