Clinical trial NCT06227247: Meals 4 Moms: A Multilevel Community-based Lifestyle Intervention for GDM
Official title: Meals 4 Moms: Development and Feasibility of a Multilevel Community-based Lifestyle Intervention for Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Diabetes
Keywords: Diabetes
Gestational diabetes
Pregnancy
Exercise
Nutrition
Diabetes education
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: University of Connecticut
name: Trinity Health Of New England
name: Hartford Hospital
First posted: 2024-01-26
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We plan to randomize 40 participants 1:1 to the M4M intervention vs usual GDM care (UC)
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability (participate again)
timeFrame: Follow-Up (within 2 weeks post-delivery)
measure: Acceptability (recommended)
timeFrame: Follow-Up (within 2 weeks post-delivery)
measure: Recruitment
timeFrame: Baseline
measure: Retention
timeFrame: Follow-Up (within 2 weeks post-delivery)
measure: Receipt of intervention (Meal Ordering)
timeFrame: Follow-Up (within 2 weeks post-delivery)
measure: Receipt of intervention (Exercise Session Completion)
timeFrame: Follow-Up (within 2 weeks post-delivery)
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UConn Health
state: Connecticut
Study officials:
affiliation: UConn Health
name: Andrea Shields, MD, MS
role: PRINCIPAL_INVESTIGATOR
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