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| ID | Type | Description | Link |
|---|---|---|---|
| 40010554 | Other Identifier | National Institute of Diabetes and Digestive and Kidney Diseases |
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| Name | Class |
|---|---|
| North Carolina Diabetes Research Center | OTHER |
| University of North Carolina, Chapel Hill | OTHER |
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The purpose of this research study is to test whether delivery of medically tailored meals (meals designed specifically to be healthy) can be used to help reduce high blood sugar after delivery of a baby. Participants will be recruited and consented during the third trimester of pregnancy but will begin study activities after delivery. Participants will complete a series of questionnaires on demographics, health history, home environment, overall and financial stress, plans for weight loss and infant feeding, and food insecurity. Participants will also be asked to wear continuous glucose monitors for two separate 14-day periods (within 2 weeks of delivery and at 3 months). All participants will receive weekly emails with educational videos and 3 virtual visits with a member of the study team and will also be randomly assigned to an intervention or comparison group. In the intervention, participants will receive weekly meal deliveries of 10 pre-prepared meals from Providence Community Kitchen (local company in Winston-Salem, NC) that are calorically restricted and appropriate for post-partum women with a history of gestational diabetes and who may be breast-feeding. Women in the control condition will receive written resources on self-care, nutrition, and physical activity appropriate for post-partum women who had gestational diabetes.
Pregnancy and delivery can function as a "stress test" for future development of cardiovascular disease and metabolic disorders, with gestational diabetes and excessive weight gain during pregnancy leading to worse outcomes later in a mother's life. The prevalence of both conditions continues to increase with the obesity epidemic, highlighting the urgent need for successful interventions to reverse maternal weight gain and promote normal blood sugars. The early postpartum period provides a critical opportunity to address diet behaviors that are related to both weight and diabetes. Postpartum medically-tailored meal delivery is a novel approach that may allow for improved blood sugar control and weight loss in a traditionally hard-to-engage patient population. There is currently no available data on the cost, feasibility, or effectiveness of providing medically-tailored meals to postpartum women. This is a pilot study of medically-tailored meals for new mothers whose pregnancies were complicated by gestational diabetes, and whose total gestational weight gain exceeded recommendations. Study will enroll 30 women with gestational diabetes and excessive gestational weight gain late in the third trimester of a singleton pregnancy. Data collection and intervention activities will begin after delivery. All participants will wear a continuous glucose monitor for baseline (first 2 weeks after delivery) and at follow up (after 3 months). Participants will also completed self-administered questionnaires, receive weekly informational videos by email, and have 3 monthly in-person check-ins with a member of the study team. Twenty participants will be randomly assigned to a medically-tailored meals intervention and 10 to a usual-care comparison group. A local community-based program will prepare and deliver 10 medically-tailored meals per week to intervention participants for their first 3 months postpartum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medically Tailored Meals | Experimental | A series of medically tailored meals appropriate for women with gestational diabetes will be developed in partnership with chefs from a local community kitchen and catering company. Meals will create a slight caloric deficit in order to promote gradual weight loss, but with sufficient energy intake and macronutrient balance to allow breastfeeding. These meals will be roughly 40% carbohydrate, 30% protein, and 30% fat in composition. Study Team will plan up to 20 unique lunch and dinner meals for the series. Each meal will be prepared to be between 450-600 kcal and to contain 6 ounces of protein, 4 ounces of vegetable and I cup of whole grain (at a minimum). Participants will receive detailed recipe cards and nutrition information with each meal. In addition to receiving the medically tailored meals, participants will be advised to supplement their own breakfast +/- snacks to reach a total daily calorie goal determined by starting BMI category. |
|
| Usual Care Comparison Group | No Intervention | Participants in this group will receive written materials on self-care, nutrition, and physical activity in the postpartum period and community resources for healthy living. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medically Tailored Meals | Behavioral | Participants will receive weekly meals (20 per week) prepared by a local community kitchen and catering group. Each week, 10 dinners and 10 lunches will be delivered to the participant's home with instructions for storage, re-heating, recipes, and nutritional information. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Meals Successfully Ordered and Delivered | Determine the percent of meals successfully ordered & delivered in the intervention group | 3 months |
| Number of Dollars Cost | Determine the total cost across all participants for the medically tailored meal program per participant assuming 20 meals per week provided to each participant for 12 weeks. | 3 months |
| Days of Continuous Glucose Monitoring in Postpartum Mothers | Tracking the number of days the continuous glucose monitors were worn (of 14 total possible) at baseline. | 14 day period assessed at baseline |
| Days of Continuous Glucose Monitoring in Postpartum Mothers | Tracking the number of days the continuous glucose monitors were worn (of 14 total possible) at 3 months. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
All participants are required to be biological Females
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| Name | Affiliation | Role |
|---|---|---|
| Morgana Mongraw-Chaffin | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27101 | United States |
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Due to recruitment limitations, we did not include a comparison group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Medically Tailored Meals | A series of medically tailored meals appropriate for women with gestational diabetes will be developed in partnership with chefs from a local community kitchen and catering company. Meals will create a slight caloric deficit in order to promote gradual weight loss, but with sufficient energy intake and macronutrient balance to allow breastfeeding. These meals will be roughly 40% carbohydrate, 30% protein, and 30% fat in composition. Study Team will plan up to 20 unique lunch and dinner meals for the series. Each meal will be prepared to be between 450-600 kcal and to contain 6 ounces of protein, 4 ounces of vegetable and I cup of whole grain (at a minimum). Participants will receive detailed recipe cards and nutrition information with each meal. In addition to receiving the medically tailored meals, participants will be advised to supplement their own breakfast +/- snacks to reach a total daily calorie goal determined by starting BMI category. Medically Tailored Meals: Participants will receive weekly meals (20 per week) prepared by a local community kitchen and catering group. Each week, 10 dinners and 10 lunches will be delivered to the participant's home with instructions for storage, re-heating, recipes, and nutritional information. |
| FG001 | Usual Care Comparison Group | Participants in this group will receive written materials on self-care, nutrition, and physical activity in the postpartum period and community resources for healthy living. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Due to recruitment limitations, we did not inlcude a comparison group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Medically Tailored Meals | A series of medically tailored meals appropriate for women with gestational diabetes will be developed in partnership with chefs from a local community kitchen and catering company. Meals will create a slight caloric deficit in order to promote gradual weight loss, but with sufficient energy intake and macronutrient balance to allow breastfeeding. These meals will be roughly 40% carbohydrate, 30% protein, and 30% fat in composition. Study Team will plan up to 20 unique lunch and dinner meals for the series. Each meal will be prepared to be between 450-600 kcal and to contain 6 ounces of protein, 4 ounces of vegetable and I cup of whole grain (at a minimum). Participants will receive detailed recipe cards and nutrition information with each meal. In addition to receiving the medically tailored meals, participants will be advised to supplement their own breakfast +/- snacks to reach a total daily calorie goal determined by starting BMI category. Medically Tailored Meals: Participants will receive weekly meals (20 per week) prepared by a local community kitchen and catering group. Each week, 10 dinners and 10 lunches will be delivered to the participant's home with instructions for storage, re-heating, recipes, and nutritional information. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Meals Successfully Ordered and Delivered | Determine the percent of meals successfully ordered & delivered in the intervention group | No comparison group was included due to limited recruitment numbers. | Posted | Count of Units | meals | 3 months | meals | meals |
|
3 months
No comparison group was included. All participants received the medically tailored meals.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Medically Tailored Meals | A series of medically tailored meals appropriate for women with gestational diabetes will be developed in partnership with chefs from a local community kitchen and catering company. Meals will create a slight caloric deficit in order to promote gradual weight loss, but with sufficient energy intake and macronutrient balance to allow breastfeeding. These meals will be roughly 40% carbohydrate, 30% protein, and 30% fat in composition. Study Team will plan up to 20 unique lunch and dinner meals for the series. Each meal will be prepared to be between 450-600 kcal and to contain 6 ounces of protein, 4 ounces of vegetable and I cup of whole grain (at a minimum). Participants will receive detailed recipe cards and nutrition information with each meal. In addition to receiving the medically tailored meals, participants will be advised to supplement their own breakfast +/- snacks to reach a total daily calorie goal determined by starting BMI category. Medically Tailored Meals: Participants will receive weekly meals (20 per week) prepared by a local community kitchen and catering group. Each week, 10 dinners and 10 lunches will be delivered to the participant's home with instructions for storage, re-heating, recipes, and nutritional information. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Morgana Mongraw-Chaffin | Wake Forest School of Medicine | 13367133108 | mmongraw@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 23, 2022 | Jul 23, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 23, 2022 | Apr 10, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D000078064 | Gestational Weight Gain |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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|
| BG001 | Usual Care Comparison Group | Participants in this group will receive written materials on self-care, nutrition, and physical activity in the postpartum period and community resources for healthy living. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Usual Care Comparison Group | Participants in this group will receive written materials on self-care, nutrition, and physical activity in the postpartum period and community resources for healthy living. |
|
|
| Primary | Number of Dollars Cost | Determine the total cost across all participants for the medically tailored meal program per participant assuming 20 meals per week provided to each participant for 12 weeks. | No comparison group was included. | Posted | Number | Number of dollars cost | 3 months |
|
|
|
| Primary | Days of Continuous Glucose Monitoring in Postpartum Mothers | Tracking the number of days the continuous glucose monitors were worn (of 14 total possible) at baseline. | No comparison group was included. | Posted | Mean | Full Range | Number of Days | 14 day period assessed at baseline |
|
|
|
| Primary | Days of Continuous Glucose Monitoring in Postpartum Mothers | Tracking the number of days the continuous glucose monitors were worn (of 14 total possible) at 3 months. | No comparison group was included due to limited recruitment numbers. | Posted | Mean | Full Range | days | 3 months |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Usual Care Comparison Group | Participants in this group will receive written materials on self-care, nutrition, and physical activity in the postpartum period and community resources for healthy living. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |