Meals 4 Moms: A Multilevel Community-based Lifestyle Intervention for GDM
NCT ID: NCT06227247
Last Updated: 2025-07-30
Study Results
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Basic Information
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TERMINATED
NA
8 participants
INTERVENTIONAL
2024-03-05
2025-01-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Meals 4 Moms intervention
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
Meals4Moms 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.
Usual GDM Care
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.
No interventions assigned to this group
Interventions
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Meals4Moms 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
49 Years
FEMALE
No
Sponsors
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University of Connecticut
OTHER
Trinity Health Of New England
OTHER
Hartford Hospital
OTHER
UConn Health
OTHER
Responsible Party
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Andrea Shields
Associate Professor
Principal Investigators
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Andrea Shields, MD, MS
Role: PRINCIPAL_INVESTIGATOR
UConn Health
Locations
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UConn Health
Farmington, Connecticut, United States
Countries
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References
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Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12.
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Berggren EK, Mele L, Landon MB, Spong CY, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Sciscione A, Catalano P, Harper M, Saade G, Caritis SN, Sorokin Y, Peaceman AM, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Perinatal outcomes in Hispanic and non-Hispanic white women with mild gestational diabetes. Obstet Gynecol. 2012 Nov;120(5):1099-104. doi: 10.1097/aog.0b013e31827049a5.
Hartling L, Dryden DM, Guthrie A, Muise M, Vandermeer B, Donovan L. Benefits and harms of treating gestational diabetes mellitus: a systematic review and meta-analysis for the U.S. Preventive Services Task Force and the National Institutes of Health Office of Medical Applications of Research. Ann Intern Med. 2013 Jul 16;159(2):123-9. doi: 10.7326/0003-4819-159-2-201307160-00661.
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Coe DP, Conger SA, Kendrick JM, Howard BC, Thompson DL, Bassett DR Jr, White JD. Postprandial walking reduces glucose levels in women with gestational diabetes mellitus. Appl Physiol Nutr Metab. 2018 May;43(5):531-534. doi: 10.1139/apnm-2017-0494. Epub 2017 Dec 22.
Onaade O, Maples JM, Rand B, Fortner KB, Zite NB, Ehrlich SF. Physical activity for blood glucose control in gestational diabetes mellitus: rationale and recommendations for translational behavioral interventions. Clin Diabetes Endocrinol. 2021 Apr 25;7(1):7. doi: 10.1186/s40842-021-00120-z.
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Hanson MA, Bardsley A, De-Regil LM, Moore SE, Oken E, Poston L, Ma RC, McAuliffe FM, Maleta K, Purandare CN, Yajnik CS, Rushwan H, Morris JL. The International Federation of Gynecology and Obstetrics (FIGO) recommendations on adolescent, preconception, and maternal nutrition: "Think Nutrition First". Int J Gynaecol Obstet. 2015 Oct;131 Suppl 4:S213-53. doi: 10.1016/S0020-7292(15)30034-5. No abstract available.
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Hordern MD, Dunstan DW, Prins JB, Baker MK, Singh MA, Coombes JS. Exercise prescription for patients with type 2 diabetes and pre-diabetes: a position statement from Exercise and Sport Science Australia. J Sci Med Sport. 2012 Jan;15(1):25-31. doi: 10.1016/j.jsams.2011.04.005. Epub 2011 May 28.
Related Links
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A Subsidized Healthy Food Prescription Program for Adults With Type 2 Diabetes Who Are Experiencing Food Insecurity: Protocol for a Randomized Controlled Trial (PMCID: PMC8265448)
Other Identifiers
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23-190SSF-2
Identifier Type: -
Identifier Source: org_study_id
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