Gestational DiabetesNCT06227247
Meals 4 Moms: A Multilevel Community-based Lifestyle Intervention for GDM
A study testing Meals4Moms Intervention in people with Gestational Diabetes, run by UConn Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Meals4Moms Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2024to 7 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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).
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Meals 4 Moms: Development and Feasibility of a Multilevel Community-based Lifestyle Intervention for Gestational Diabetes
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.
Read the 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.
- Conditions
- Gestational Diabetes
- Being tested
- Meals4Moms Intervention
- Keywords
- Diabetes, Gestational diabetes, Pregnancy, Exercise, Nutrition, Diabetes education
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meals4Moms InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Meals4Moms Intervention |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability (Participate Again)
Percent of participants who report they would be likely or very likely to participate again if they had gestational diabetes (GDM) again.
Measured: Follow-Up (aim: within 2 weeks post-delivery)
Acceptability (Recommended)
Percent of participants who report they would be likely to very likely to recommend the M4M intervention to a friend with gestational diabetes (GDM).
Measured: Follow-Up (aim: within 2 weeks post-delivery)
Recruitment
Recruitment rates will be calculated from the number of patients approached and reasons for ineligibility and non-participation.
Measured: Baseline
Retention
Percent of participants who complete any aspect of the follow-up assessment.
Measured: Follow-Up (aim: within 2 weeks post-delivery)
Receipt of Intervention (Meal Ordering)
Percent of participants who spent at least 80% of weekly $266 food budget.
Measured: Follow-Up (aim: within 2 weeks post-delivery)
Receipt of Intervention (Exercise Session Completion)
Percent of participants who completed at least 80% of exercise sessions they were eligible to complete.
Measured: Follow-Up (aim: within 2 weeks post-delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start5 Mar 2024
- Primary completion16 Dec 2024
- Study completion7 Jan 2025
Why it stopped: Recruitment pace was not sufficient to support fully-powered efficacy trial. Study investigators decided to terminate the feasibility trial before reaching recruitment target.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We plan to randomize 40 participants 1:1 to the M4M intervention vs usual GDM care (UC)
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Connecticut, Trinity Health Of New England, Hartford Hospital
- Responsible party
- Principal investigator, Andrea Shields, UConn Health
- Investigators
- Andrea Shields, MD, MS, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227247
- Sponsor's protocol ID
- 23-190SSF-2
- Status last verified
- Apr 2026
- First submitted
- 17 Jan 2024
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15951574Cosson E, Baz B, Gary F, Pharisien I, Nguyen MT, Sandre-Banon D, Jaber Y, Cussac-Pillegand C, Banu I, Carbillon L, Valensi P. Poor Reliability and Poor Adherence to Self-Monitoring of Blood Glucose Are Common in Women With Gestational Diabetes Mellitus and May Be Associated With Poor Pregnancy Outcomes. Diabetes Care. 2017 Sep;40(9):1181-1186. doi: 10.2337/dc17-0369. Epub 2017 Jul 19.
PubMed 28724718HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
PubMed 18463375Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Lain KY, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GB; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med. 2009 Oct 1;361(14):1339-48. doi: 10.1056/NEJMoa0902430.
PubMed 19797280Berggren 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.
PubMed 23090528Hartling 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.
PubMed 23712381Chan CWH, Au Yeung E, Law BMH. Effectiveness of Physical Activity Interventions on Pregnancy-Related Outcomes among Pregnant Women: A Systematic Review. Int J Environ Res Public Health. 2019 May 23;16(10):1840. doi: 10.3390/ijerph16101840.
PubMed 31126153Garcia-Patterson A, Martin E, Ubeda J, Maria MA, de Leiva A, Corcoy R. Evaluation of light exercise in the treatment of gestational diabetes. Diabetes Care. 2001 Nov;24(11):2006-7. doi: 10.2337/diacare.24.11.2006. No abstract available.
PubMed 11679479Avery MD, Walker AJ. Acute effect of exercise on blood glucose and insulin levels in women with gestational diabetes. J Matern Fetal Med. 2001 Feb;10(1):52-8. doi: 10.1080/714904296.
PubMed 11332421Coe 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.
PubMed 29272606Onaade 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.
PubMed 33896420Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
PubMed 3651732Weiss BD, Mays MZ, Martz W, Castro KM, DeWalt DA, Pignone MP, Mockbee J, Hale FA. Quick assessment of literacy in primary care: the newest vital sign. Ann Fam Med. 2005 Nov-Dec;3(6):514-22. doi: 10.1370/afm.405.
PubMed 16338915Hanson 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.
PubMed 26433230Chen TC, Clark J, Riddles MK, Mohadjer LK, Fakhouri THI. National Health and Nutrition Examination Survey, 2015-2018: Sample Design and Estimation Procedures. Vital Health Stat 2. 2020 Apr;(184):1-35.
PubMed 33663649
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meals 4 Moms: Development and Feasibility of a Multilevel Community-based Lifestyle Intervention for Gestational Diabetes
- ClinicalTrials.gov ID
- NCT06227247
- Acronym / sponsor ID
- 23-190SSF-2
- Conditions
- Gestational Diabetes
- Keywords
- Diabetes, Gestational diabetes, Pregnancy, Exercise, Nutrition, Diabetes education
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment pace was not sufficient to support fully-powered efficacy trial. Study investigators decided to terminate the feasibility trial before reaching recruitment target.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- University of Connecticut, Trinity Health Of New England, Hartford Hospital
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 26 Jan 2024 (actual)
- Results
- Posted 17 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We plan to randomize 40 participants 1:1 to the M4M intervention vs usual GDM care (UC)
| Arm | Type | Receives |
|---|---|---|
| Meals 4 Moms intervention | Experimental | Behavioral: Meals4Moms InterventionParticipants 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 |
| 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meals4Moms InterventionA 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. | Behavioural | Meals 4 Moms intervention |
Primary outcome
Acceptability (Participate Again)
Time frame: 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)
Time frame: 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
Time frame: Baseline
Recruitment rates will be calculated from the number of patients approached and reasons for ineligibility and non-participation.
Retention
Time frame: 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)
Time frame: 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)
Time frame: Follow-Up (aim: within 2 weeks post-delivery)
Percent of participants who completed at least 80% of exercise sessions they were eligible to complete.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15951574Crowther 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.
- Background: PubMed 28724718Cosson E, Baz B, Gary F, Pharisien I, Nguyen MT, Sandre-Banon D, Jaber Y, Cussac-Pillegand C, Banu I, Carbillon L, Valensi P. Poor Reliability and Poor Adherence to Self-Monitoring of Blood Glucose Are Common in Women With Gestational Diabetes Mellitus and May Be Associated With Poor Pregnancy Outcomes. Diabetes Care. 2017 Sep;40(9):1181-1186. doi: 10.2337/dc17-0369. Epub 2017 Jul 19.
- Background: PubMed 18463375HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
- Background: PubMed 19797280Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Lain KY, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GB; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med. 2009 Oct 1;361(14):1339-48. doi: 10.1056/NEJMoa0902430.
- Background: PubMed 23090528Berggren 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.
- Background: PubMed 23712381Hartling 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.
- Background: PubMed 31126153Chan CWH, Au Yeung E, Law BMH. Effectiveness of Physical Activity Interventions on Pregnancy-Related Outcomes among Pregnant Women: A Systematic Review. Int J Environ Res Public Health. 2019 May 23;16(10):1840. doi: 10.3390/ijerph16101840.
- Background: PubMed 11679479Garcia-Patterson A, Martin E, Ubeda J, Maria MA, de Leiva A, Corcoy R. Evaluation of light exercise in the treatment of gestational diabetes. Diabetes Care. 2001 Nov;24(11):2006-7. doi: 10.2337/diacare.24.11.2006. No abstract available.
- Background: PubMed 11332421Avery MD, Walker AJ. Acute effect of exercise on blood glucose and insulin levels in women with gestational diabetes. J Matern Fetal Med. 2001 Feb;10(1):52-8. doi: 10.1080/714904296.
- Background: PubMed 29272606Coe 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.
- Background: PubMed 33896420Onaade 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.
- Background: PubMed 3651732Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
- Centers for Disease Control. Gestational Diabetes.Link provided by the sponsor.
- 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)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Shields, MD, MS principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meals4Moms Intervention in people with Gestational Diabetes, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (Participate Again) (time frame: Follow-Up (aim: within 2 weeks post-delivery)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06227247, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.