Gestational Diabetes
Conditions
Keywords
Diabetes, Gestational diabetes, Pregnancy, Exercise, Nutrition, Diabetes education
Brief summary
The goal of the project is to conduct a pilot feasibility randomized trial comparing a community-based lifestyle intervention called Meals for Moms (M4M) versus the usual care for pregnant persons diagnosed with gestational diabetes (GDM). Participants will be randomly placed into the usual care (UC) comparison group or the M4M healthy living program, which includes continued GDM education, physical activity level monitoring, and delivery of medically-tailored GDM meals. The trial will assess if M4M is feasible for the management of gestational diabetes in pregnant patients.
Detailed description
Gestational diabetes mellitus, or GDM, affects many pregnancies throughout the United States contributing to an increased risk of negative pregnancy outcomes such as delivery complications, hospitalizations, and poor clinical outcomes for both patients and infants. Additionally, many pregnant patients with GDM will progress to developing Type 2 diabetes within their lifetime. GDM, therefore, is the perfect window of opportunity for the prevention of diabetes. GDM management requires education and adoption of a specific diet, daily blood sugar monitoring, exercise, and compliance with prenatal visits. Adopting all these changes may be hard to understand and comply with in a short window of time as, on average, patients are diagnosed GDM 8 to 10 before delivery. Thus, to achieve these goals quickly, patients must have immediate access to nutrient-rich food, and on-going education and support regarding healthy-meal preparation, including portion sizes, frequency, and composition of healthy snacking. Previous and on-going research on health food prescription programs and supervised exercise sessions are often not performed with patients with GDM. To address this gap, investigators aim to develop a lifestyle intervention that promotes self-efficacy with unsupervised exercise and evidence-based behavioral strategies (e.g. goal setting, monitoring and feedback) and incorporate the use of physical activity tracking devices to support these strategies. This project has two distinct phases. First, to develop the novel Meals for Moms (M4M) community-based lifestyle intervention using feedback and input from women living with GDM. Second, to conduct a pilot feasibility randomized trial comparing the feasibility, compliance, and acceptability of the M4M intervention versus the usual care for pregnant persons diagnosed with GDM.
Interventions
BEHAVIORALMeals4Moms Intervention
A community-based, healthy living program including continued gestational diabetes (GDM) education, physical activity level monitoring, and delivery of medically-tailored GDM meals for the management of gestational diabetes in pregnant people.
Sponsors
UConn Health
University of Connecticut
Trinity Health Of New England
Hartford Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
We plan to randomize 40 participants 1:1 to the M4M intervention vs usual GDM care (UC)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* 18-49 years old * Current singleton pregnancy * GDM diagnosis between 24+0 and 31+6 weeks gestation, and no more than 4weeks from time of diagnosis at time of enrollment. * Currently receiving gestational diabetes management at the UConn Health Maternal Fetal Clinic, St. Francis's Hospital Women's Health clinic, Hartford Healthcare Women's Ambulatory Health Services (WAHS) * Intends to deliver at either UConn Health, St. Francis Hospital or Hartford Healthcare * Able to read and understand English well enough to participate in the study in English * Daily access to the internet from smartphone, tablet computer, or laptop/desktop computer that they can use to participate in the study * Medical clearance to participate from prenatal care provider including clearance to engage in physical activity * Able to provide verbal or written consent for each component of the study procedures and data collection * Currently lives within one of the meal delivery areas in Connecticut to allow for meal delivery (total of 32 eligible towns/cities)
Exclusion criteria
* Unable or unwilling to give informed consent or communicate with study staff. * Diabetes mellitus (Type I or Type II). * GDM diagnosed prior to 24 weeks gestation or after 32+0 weeks gestation. * Patient is scheduled for a preterm delivery for medical reasons (i.e., placenta accreta, prior classical incision) at time of eligibility screening or at any time prior to randomization. * Concurrent participation in another research study providing intervention related to GDM, pregnancy, diet, and/or physical activity. * Medical conditions that may result in the inability to tolerate solid foods (i.e., hyperemesis gravidarum). * Medical condition which would prohibit participation as indicated by prenatal care provider providing medical clearance. * Dietary restrictions that cannot be accommodated for during meal preparation. * Currently does not live in one of the towns listed within the meal delivery area. * Has plans to move to out of the meal delivery area between enrollment and expected pregnancy due date.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability (Participate Again) | Follow-Up (aim: within 2 weeks post-delivery) | Percent of participants who report they would be likely or very likely to participate again if they had gestational diabetes (GDM) again. |
| Acceptability (Recommended) | Follow-Up (aim: within 2 weeks post-delivery) | Percent of participants who report they would be likely to very likely to recommend the M4M intervention to a friend with gestational diabetes (GDM). |
| Recruitment | Baseline | Recruitment rates will be calculated from the number of patients approached and reasons for ineligibility and non-participation. |
| Retention | Follow-Up (aim: within 2 weeks post-delivery) | Percent of participants who complete any aspect of the follow-up assessment. |
| Receipt of Intervention (Meal Ordering) | Follow-Up (aim: within 2 weeks post-delivery) | Percent of participants who spent at least 80% of weekly $266 food budget. |
| Receipt of Intervention (Exercise Session Completion) | Follow-Up (aim: within 2 weeks post-delivery) | Percent of participants who completed at least 80% of exercise sessions they were eligible to complete. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAndrea Shields, MD, MS
UConn Health
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 30.5 years STANDARD_DEVIATION 3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 1 / 4 | 1 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
None listed