Meals 4 Moms: Development and Feasibility of a Multilevel Community-based Lifestyle Intervention for Gestational Diabetes

UConn Health1 个研究点分布在 1 个国家目标入组 8 人开始时间: 2024年3月5日最近更新: 2026年5月5日

适应症

干预措施

试验速览

阶段: 不适用
状态: 终止
发起方
入组人数: 8
试验地点: 1
主要终点: Recruitment

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Supportive Care
盲法: None

入排标准

年龄范围: 18 Years 至 49 Years（Adult）
性别: Female
接受健康志愿者: 否

入选标准

•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)

排除标准

•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.

研究组 & 干预措施

Usual GDM Care

No Intervention

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.

Meals 4 Moms intervention

Experimental

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

干预措施: Meals4Moms Intervention (Behavioral)

结局指标

主要结局

Recruitment

时间窗: Baseline

Recruitment rates will be calculated from the number of patients approached and reasons for ineligibility and non-participation.

Receipt of Intervention (Meal Ordering)