Meals 4 Moms: A Multilevel Community-based Lifestyle Intervention for GDM
A legfontosabb adatok
- Ki végzi
- UConn Health
- Hol
- Farmington (Egyesült Államok)A helyszín megnézése
- Azonosító
- Állapot
- Leállítva
- Résztvevők
- 8 fő vett részt
- Kezdés
- 2024. márc. 5.
- Befejezés
- 2025. jan. 7.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport nem kap vizsgálati kezelést, összehasonlításként.
- A vizsgált kezelések
- Meals4Moms Intervention
- A regiszteradat frissítve
- 2026. május 5.
- Miért állt le
- Recruitment pace was not sufficient to support fully-powered efficacy trial. Study investigators decided to terminate the feasibility trial before reaching recruitment target.
Ki vehet részt
- Életkor
- 18 év – 49 év
- Nem
- Csak nők
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 20 feltétel megnézéseKevesebb
Ki vehet részt
- 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)
Ki nem vehet részt
- 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
- Diabetes mellitus (Type I or Type II)
- 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
- Unable or unwilling to give informed consent or communicate with study staff
- 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
Helyszínek itt: Egyesült Államok
- UConn HealthFarmington, Egyesült Államok
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A vizsgálat 2 csoportja
- Meals 4 Moms interventionA vizsgált kezelés
Participants randomized to the M4M condition will receive: * Food budget of $266 per week in credits to spend towards medically-tailored GDM meals * Enhanced educational GDM-specific education on exercise, nutrition, and blood sugar glucose management * Activity tracker and digital scale * Usual GDM care
Kezelés: Meals4Moms Intervention
- Usual GDM CareNincs vizsgálati kezelés, összehasonlításként
Usual care (UC) will consist of the current treatment care that is provided by the participant's prenatal care provider. Usual care consists of a special diet, monitoring of blood glucose levels and encouragement/guidance of increasing a participant's exercise.
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Meals 4 Moms: Development and Feasibility of a Multilevel Community-based Lifestyle Intervention for Gestational Diabetes
- A regiszteradat frissítve
- 2026. május 5.