Trial Outcomes & Findings for Meals 4 Moms: A Multilevel Community-based Lifestyle Intervention for GDM (NCT NCT06227247)
NCT ID: NCT06227247
Last Updated: 2026-05-05
Results Overview
Percent of participants who report they would be likely or very likely to participate again if they had gestational diabetes (GDM) again.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
Follow-Up (aim: within 2 weeks post-delivery)
Results posted on
2026-05-05
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Meals 4 Moms: A Multilevel Community-based Lifestyle Intervention for GDM
Baseline characteristics by cohort
| Measure |
Meals 4 Moms Intervention
n=4 Participants
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
n=4 Participants
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.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 3.9 • n=54 Participants
|
30.5 years
STANDARD_DEVIATION 3.0 • n=60 Participants
|
33.0 years
STANDARD_DEVIATION 4.2 • n=114 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=54 Participants
|
4 Participants
n=60 Participants
|
8 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
7 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=54 Participants
|
4 Participants
n=60 Participants
|
8 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=54 Participants
|
4 participants
n=60 Participants
|
8 participants
n=114 Participants
|
PRIMARY outcome
Timeframe: Follow-Up (aim: within 2 weeks post-delivery)Population: Only participants in the Meals4Moms arm were asked acceptability questions
Percent of participants who report they would be likely or very likely to participate again if they had gestational diabetes (GDM) again.
Outcome measures
| Measure |
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.
|
Meals 4 Moms Intervention
n=4 Participants
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.
|
|---|---|---|
|
Acceptability (Participate Again)
|
0 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Follow-Up (aim: within 2 weeks post-delivery)Population: Only participants in the Meals4Moms arm were asked acceptability questions.
Percent of participants who report they would be likely to very likely to recommend the M4M intervention to a friend with gestational diabetes (GDM).
Outcome measures
| Measure |
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.
|
Meals 4 Moms Intervention
n=4 Participants
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.
|
|---|---|---|
|
Acceptability (Recommended)
|
0 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Pregnant patients with GDM contacted for eligibility screening
Recruitment rates will be calculated from the number of patients approached and reasons for ineligibility and non-participation.
Outcome measures
| Measure |
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.
|
Meals 4 Moms Intervention
n=30 Participants
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.
|
|---|---|---|
|
Recruitment
Could not reach/no response
|
—
|
3 Participants
|
|
Recruitment
Not interested in participating
|
—
|
3 Participants
|
|
Recruitment
Screened ineligible
|
—
|
6 Participants
|
|
Recruitment
Eligible but did not complete baseline survey
|
—
|
4 Participants
|
|
Recruitment
Consented but did not complete baseline procedures
|
—
|
6 Participants
|
|
Recruitment
Randomized
|
—
|
8 Participants
|
PRIMARY outcome
Timeframe: Follow-Up (aim: within 2 weeks post-delivery)Percent of participants who complete any aspect of the follow-up assessment.
Outcome measures
| Measure |
Usual GDM Care
n=4 Participants
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
n=4 Participants
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.
|
|---|---|---|
|
Retention
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Follow-Up (aim: within 2 weeks post-delivery)Population: Only participants in the Meals4Moms arm received meals. Percent of meal budget based on food orders eligible to place (not number orders placed).
Percent of participants who spent at least 80% of weekly $266 food budget.
Outcome measures
| Measure |
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.
|
Meals 4 Moms Intervention
n=4 Participants
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.
|
|---|---|---|
|
Receipt of Intervention (Meal Ordering)
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Follow-Up (aim: within 2 weeks post-delivery)Population: Only participants in the Meals4Moms arm engaged in exercise sessions with the trainer.
Percent of participants who completed at least 80% of exercise sessions they were eligible to complete.
Outcome measures
| Measure |
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.
|
Meals 4 Moms Intervention
n=4 Participants
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.
|
|---|---|---|
|
Receipt of Intervention (Exercise Session Completion)
|
0 Participants
|
0 Participants
|
Adverse Events
Meals 4 Moms Intervention
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Usual GDM Care
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Meals 4 Moms Intervention
n=4 participants at risk
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
n=4 participants at risk
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.
|
|---|---|---|
|
Renal and urinary disorders
Kidney stones
|
0.00%
0/4 • from baseline assessment until end of follow-up (approximately 2 weeks post-delivery)
|
25.0%
1/4 • Number of events 1 • from baseline assessment until end of follow-up (approximately 2 weeks post-delivery)
|
|
Psychiatric disorders
Elevated depressive symptoms at baseline
|
25.0%
1/4 • Number of events 1 • from baseline assessment until end of follow-up (approximately 2 weeks post-delivery)
|
25.0%
1/4 • Number of events 1 • from baseline assessment until end of follow-up (approximately 2 weeks post-delivery)
|
|
Psychiatric disorders
Elevated depressive symptoms at follow-up
|
25.0%
1/4 • Number of events 1 • from baseline assessment until end of follow-up (approximately 2 weeks post-delivery)
|
0.00%
0/2 • from baseline assessment until end of follow-up (approximately 2 weeks post-delivery)
|
Additional Information
Dr. Molly Waring (study statistician)
University of Connecticut
Phone: 860-486-1446
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place