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| ID | Type | Description | Link |
|---|---|---|---|
| 1U54CA280804-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| M.D. Anderson Cancer Center | OTHER |
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The purpose of this study is to assess the effect of an adapted virtual Culinary Medicine (CM) curriculum on dietary behaviors, nutrition knowledge, and cooking skills and behaviors on outcomes such as HbA1c levels, Body Mass Index, Blood Pressure, HDL, LDL, and Triglycerides, as well as to determine the feasibility and reproducibility of virtual synchronous CM classes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinics Receiving the Culinary Medicine Program | Experimental | Participants will take part in the Culinary Medicine Program and will be recruited at University of Texas (UT) Physician Clinics serving the Acres Homes neighborhood in Houston. |
|
| Control Clinics | No Intervention | Participants will be recruited from UT Physicians clinics outside of the Acres Homes service area. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Culinary Medicine Program | Behavioral | The virtual curriculum will include five 90-minute sessions (to be held weekly or bi-weekly) on basic cooking skills with behaviorally-based nutrition education. Participants will also be expected to shop for groceries ahead of the sessions to participate in the program. A gift card will be provided for groceries. Asynchronous virtual educational content (cooking skills videos, animated nutrition education videos, and additional recipes) will be provided to engage and retain participants beyond initial sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c (HbA1c) Level | Marginal mean is reported. | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | Marginal mean is reported. | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
| Systolic Blood Pressure | Marginal mean is reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalia I Heredia, PhD., MPH | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clinics Receiving the Culinary Medicine Program | Participants will take part in the Culinary Medicine Program and will be recruited at University of Texas (UT) Physician Clinics serving the Acres Homes neighborhood in Houston. Culinary Medicine Program: The virtual curriculum will include five 90-minute sessions (to be held weekly or bi-weekly) on basic cooking skills with behaviorally-based nutrition education. Participants will also be expected to shop for groceries ahead of the sessions to participate in the program. A gift card will be provided for groceries. Asynchronous virtual educational content (cooking skills videos, animated nutrition education videos, and additional recipes) will be provided to engage and retain participants beyond initial sessions. |
| FG001 | Control Clinics | Participants will be recruited from UT Physicians clinics outside of the Acres Homes service area. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
1 participant in the Control Clinic arm chose not to report their sex. 1 participant in the Culinary Medicine arm chose not to report their race/ethnicity, and 3 participants in the Control arm chose not to report their race/ethnicity.
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| ID | Title | Description |
|---|---|---|
| BG000 | Clinics Receiving the Culinary Medicine Program | Participants will take part in the Culinary Medicine Program and will be recruited at University of Texas (UT) Physician Clinics serving the Acres Homes neighborhood in Houston. Culinary Medicine Program: The virtual curriculum will include five 90-minute sessions (to be held weekly or bi-weekly) on basic cooking skills with behaviorally-based nutrition education. Participants will also be expected to shop for groceries ahead of the sessions to participate in the program. A gift card will be provided for groceries. Asynchronous virtual educational content (cooking skills videos, animated nutrition education videos, and additional recipes) will be provided to engage and retain participants beyond initial sessions. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Hemoglobin A1c (HbA1c) Level | Marginal mean is reported. | Data are not available at baseline for 18 in the Culinary Medicine Intervention Arm and 7 in the Control Arm or at program completion for 25 in the Culinary Medicine Intervention Arm and 17 in the Control Arm--this is because HbA1c testing at these timepoints was not performed in these participants and was therefore not available in the medical record. | Posted | Mean | 95% Confidence Interval | mmol/mol | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
|
at program completion (within 90 days of NCCM program completion)
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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 | Clinics Receiving the Culinary Medicine Program | Participants will take part in the Culinary Medicine Program and will be recruited at University of Texas (UT) Physician Clinics serving the Acres Homes neighborhood in Houston. Culinary Medicine Program: The virtual curriculum will include five 90-minute sessions (to be held weekly or bi-weekly) on basic cooking skills with behaviorally-based nutrition education. Participants will also be expected to shop for groceries ahead of the sessions to participate in the program. A gift card will be provided for groceries. Asynchronous virtual educational content (cooking skills videos, animated nutrition education videos, and additional recipes) will be provided to engage and retain participants beyond initial sessions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Natalia I. Heredia, Assistant Professor | The University of Texas Health Science Center at Houston | (713) 500-9600 | natalia.i.heredia@uth.tmc.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 | Apr 8, 2024 | Dec 3, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 15, 2024 | Dec 3, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
| Diastolic Blood Pressure | Marginal mean is reported. | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
| High-density Lipoprotein (HDL) Level | Marginal mean is reported. | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
| Low-density Lipoprotein (LDL) Level | Marginal mean is reported. | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
| Triglyceride Level | Marginal mean is reported. | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
| Perceived Health as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | This is a 1-item questionnaire that asks "Overall, how would you rate your health in the past four weeks?," and it is reported categorically in 6 categories: Excellent, Very Good, Good, Fair, Poor, and Very Poor. | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
| Fruit and Vegetable Consumption as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | This is a 1-item questionnaire that asks "How many servings of VEGETABLES do you eat or drink each day?," and it is reported as number of servings consumed each day. Marginal mean is reported. | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
| Whole Grain Consumption as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | This is a 1-item questionnaire that asks "How many servings of Whole Grains do you eat each day?," and it is reported categorically in 6 categories: 4 servings or more; 2-3 servings; 1-2 servings; 1/2 to 1 serving; 1/2 serving or less; or none. | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
| Typical Healthy Food Consumption Behaviors as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | Total score ranges from 0-4, with a higher score indicating greater healthy food consumption behaviors. Marginal mean is reported. | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
| Perceived Barriers of Eating Fruits and Vegetables as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | Total score ranges from 1 to 5, with a higher score indicating less barriers. | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
| Eating, Cooking, and Shopping (i.e., Using Nutrition Label) Behaviors as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | Total score ranges from 0-4, with a higher score indicating better eating, cooking, and shopping behaviors. Marginal mean is reported. | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
| Barriers to Healthy Eating as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | Total score ranges from 1 to 5, with a higher score indicating less barriers. This outcome measure includes assessment of barriers to eating fruits and vegetables, as well as barriers to overall healthy eating. Marginal mean is reported. | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
| Self-efficacy in Cooking Food and Meal Planning as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | Total score ranges from 1 to 5, with a greater score indicating greater self-efficacy. Marginal mean is reported. | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
| Diabetes Self-Management as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | Total score ranges from 1 to 4, with a higher score indicating better diabetes self-management. Marginal mean is reported. | Baseline, post intervention (up to 10 weeks after baseline) |
| BG001 | Control Clinics | Participants will be recruited from UT Physicians clinics outside of the Acres Homes service area. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Control Clinics | Participants will be recruited from UT Physicians clinics outside of the Acres Homes service area. |
|
|
| Secondary | Body Mass Index | Marginal mean is reported. | Data are not available at baseline for 13 in the Culinary Medicine Intervention Arm and 3 in the Control Arm or at program completion for 18 in the Culinary Medicine Intervention Arm and 5 in the Control Arm--this is because BMI data were not collected at these timepoints in these participants and were therefore not available in the medical record. | Posted | Mean | 95% Confidence Interval | kg/m^2 | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
|
|
|
| Secondary | Systolic Blood Pressure | Marginal mean is reported. | Data are not available at baseline for 14 in the Culinary Medicine Intervention Arm and 4 in the Control Arm or at program completion for 19 in the Culinary Medicine Intervention Arm and 6 in the Control Arm--this is because blood pressure data were not collected at these timepoints in these participants and was therefore not available in the medical record. | Posted | Mean | 95% Confidence Interval | mmHg | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
|
|
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| Secondary | Diastolic Blood Pressure | Marginal mean is reported. | Data are not available at baseline for 14 in the Culinary Medicine Intervention Arm and 4 in the Control Arm or at program completion for 19 in the Culinary Medicine Intervention Arm and 6 in the Control Arm--this is because blood pressure data were not collected at these timepoints in these participants and was therefore not available in the medical record. | Posted | Mean | 95% Confidence Interval | mmHg | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
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| Secondary | High-density Lipoprotein (HDL) Level | Marginal mean is reported. | Data are not available at baseline for 33 in the Culinary Medicine Intervention Arm and 15 in the Control Arm or at program completion for 44 in the Culinary Medicine Intervention Arm and 28 in the Control Arm--this is because HDL level data were not collected at these timepoints in these participants and was therefore not available in the medical record. | Posted | Mean | 95% Confidence Interval | mg/dL | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
|
|
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| Secondary | Low-density Lipoprotein (LDL) Level | Marginal mean is reported. | Data are not available at baseline for 36 in the Culinary Medicine Intervention Arm and 15 in the Control Arm or at program completion for 44 in the Culinary Medicine Intervention Arm and 28 in the Control Arm--this is because LDL level data were not collected at these timepoints in these participants and was therefore not available in the medical record. | Posted | Mean | 95% Confidence Interval | mg/dL | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
|
|
|
| Secondary | Triglyceride Level | Marginal mean is reported. | Data are not available at baseline for 33 in the Culinary Medicine Intervention Arm and 15 in the Control Arm or at program completion for 44 in the Culinary Medicine Intervention Arm and 28 in the Control Arm--this is because Triglyceride level data were not collected at these timepoints in these participants and was therefore not available in the medical record. | Posted | Mean | 95% Confidence Interval | mg/dL | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
|
|
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| Secondary | Perceived Health as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | This is a 1-item questionnaire that asks "Overall, how would you rate your health in the past four weeks?," and it is reported categorically in 6 categories: Excellent, Very Good, Good, Fair, Poor, and Very Poor. | Data are not available at baseline for 9 in the Culinary Medicine Intervention Arm and 1 in the Control Arm or at program completion for 13 in the Culinary Medicine Intervention Arm and 10 in the Control Arm because this survey was not completed by these participants at these timepoints. | Posted | Count of Participants | Participants | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
|
|
|
| Secondary | Fruit and Vegetable Consumption as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | This is a 1-item questionnaire that asks "How many servings of VEGETABLES do you eat or drink each day?," and it is reported as number of servings consumed each day. Marginal mean is reported. | Data are not available at baseline for 10 in the Culinary Medicine Intervention Arm or at program completion for 15 in the Culinary Medicine Intervention Arm and 10 in the Control Arm because this survey was not completed by these participants at these timepoints. | Posted | Mean | 95% Confidence Interval | number of servings | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
|
|
|
| Secondary | Whole Grain Consumption as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | This is a 1-item questionnaire that asks "How many servings of Whole Grains do you eat each day?," and it is reported categorically in 6 categories: 4 servings or more; 2-3 servings; 1-2 servings; 1/2 to 1 serving; 1/2 serving or less; or none. | Data are not available at baseline for 8 in the Culinary Medicine Intervention Arm and 1 in the Control Arm or at program completion for 14 in the Culinary Medicine Intervention Arm and 10 in the Control Arm because this survey was not completed by these participants at these timepoints. | Posted | Count of Participants | Participants | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
|
|
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| Secondary | Typical Healthy Food Consumption Behaviors as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | Total score ranges from 0-4, with a higher score indicating greater healthy food consumption behaviors. Marginal mean is reported. | Data are not available at baseline for 8 in the Culinary Medicine Intervention Arm and 1 in the Control Arm or at program completion for 13 in the Culinary Medicine Intervention Arm and 10 in the Control Arm because this survey was not completed by these participants at these timepoints. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
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| Secondary | Perceived Barriers of Eating Fruits and Vegetables as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | Total score ranges from 1 to 5, with a higher score indicating less barriers. | This outcome measure was pre-specified in the study protocol; however, no data were collected. The study team determined that collecting this measure would increase participant burden and be redundant, as Outcome Measure 14 reports both barriers to eating fruits and vegetables and barriers to healthy eating overall as one score. The study protocol was not amended to reflect this decision. Data collection and analysis for this outcome measure will not be conducted in the future. | Posted | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
|
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| Secondary | Eating, Cooking, and Shopping (i.e., Using Nutrition Label) Behaviors as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | Total score ranges from 0-4, with a higher score indicating better eating, cooking, and shopping behaviors. Marginal mean is reported. | Data are not available at baseline for 8 in the Culinary Medicine Intervention Arm and 2 in the Control Arm or at program completion for 14 in the Culinary Medicine Intervention Arm and 9 in the Control Arm because this survey was not completed by these participants at these timepoints. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
|
|
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| Secondary | Barriers to Healthy Eating as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | Total score ranges from 1 to 5, with a higher score indicating less barriers. This outcome measure includes assessment of barriers to eating fruits and vegetables, as well as barriers to overall healthy eating. Marginal mean is reported. | Data are not available at baseline for 9 in the Culinary Medicine Intervention Arm and 2 in the Control Arm or at program completion for 14 in the Culinary Medicine Intervention Arm and 10 in the Control Arm because this survey was not completed by these participants at these timepoints. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
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| Secondary | Self-efficacy in Cooking Food and Meal Planning as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | Total score ranges from 1 to 5, with a greater score indicating greater self-efficacy. Marginal mean is reported. | Data are not available at baseline for 8 in the Culinary Medicine Intervention Arm and 1 in the Control Arm or at program completion for 13 in the Culinary Medicine Intervention Arm and 9 in the Control Arm because this survey was not completed by these participants at these timepoints. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) |
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| Secondary | Diabetes Self-Management as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | Total score ranges from 1 to 4, with a higher score indicating better diabetes self-management. Marginal mean is reported. | Data are not available at baseline for 11 in the Culinary Medicine Intervention Arm and 1 in the Control Arm or at program completion for 14 in the Culinary Medicine Intervention Arm and 11 in the Control Arm because this survey was not completed by these participants at these timepoints. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, post intervention (up to 10 weeks after baseline) |
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| 0 |
| 58 |
| 0 |
| 58 |
| 0 |
| 58 |
| EG001 | Control Clinics | Participants will be recruited from UT Physicians clinics outside of the Acres Homes service area. | 0 | 31 | 0 | 31 | 0 | 31 |
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| At Program Completion |
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| At Program Completion |
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| At Program Completion |
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| At program completion |
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| At program completion |
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| At program completion |
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| Very Good |
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| Good |
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| Fair |
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| Poor |
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| Very Poor |
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| At Program Completion |
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| At Program Completion |
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| 2-3 servings |
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| 1-2 servings |
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| 1/2 to 1 serving |
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| 1/2 serving or less |
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| none |
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| At Program Completion |
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| At Program Completion |
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| At Program Completion |
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| At Program Completion |
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| At Program Completion |
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| Post Intervention (up to 10 weeks after baseline) |
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