Diabetes, Elevated Body Mass Index
Conditions
Brief summary
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.
Interventions
BEHAVIORALCulinary 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.
Sponsors
The University of Texas Health Science Center, Houston
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Receiving care at UT Physicians clinics * diagnosed with type 2 diabetes and elevated body mass index (\>=25) * HbA1c labs and clinic-assessed weight completed within the last 3 months * English speaking or Spanish speaking * Can obtain groceries before each class (intervention group only)
Exclusion criteria
* Patients without the technological support needed to participate (e.g., reliable internet and device - cell phone, tablet or laptop) * Patients with an uncontrolled impairment that interferes with ability to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c (HbA1c) Level | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) | Marginal mean is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) | Marginal mean is reported. |
| Systolic Blood Pressure | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) | Marginal mean is reported. |
| Diastolic Blood Pressure | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) | Marginal mean is reported. |
| High-density Lipoprotein (HDL) Level | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) | Marginal mean is reported. |
| Low-density Lipoprotein (LDL) Level | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) | Marginal mean is reported. |
| Triglyceride Level | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) | Marginal mean is reported. |
| Perceived Health as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) | 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. |
| Whole Grain Consumption as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) | 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. |
| Typical Healthy Food Consumption Behaviors as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) | Total score ranges from 0-4, with a higher score indicating greater healthy food consumption behaviors. Marginal mean is reported. |
| Perceived Barriers of Eating Fruits and Vegetables as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) | Total score ranges from 1 to 5, with a higher score indicating less barriers. |
| Eating, Cooking, and Shopping (i.e., Using Nutrition Label) Behaviors as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) | Total score ranges from 0-4, with a higher score indicating better eating, cooking, and shopping behaviors. Marginal mean is reported. |
| Barriers to Healthy Eating as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) | 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. |
| Self-efficacy in Cooking Food and Meal Planning as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) | Total score ranges from 1 to 5, with a greater score indicating greater self-efficacy. Marginal mean is reported. |
| Fruit and Vegetable Consumption as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion) | 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. |
| Diabetes Self-Management as Assessed by the Nourishing the Community Through Culinary Medicine Survey (NCCM) | Baseline, post intervention (up to 10 weeks after baseline) | Total score ranges from 1 to 4, with a higher score indicating better diabetes self-management. Marginal mean is reported. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNatalia I Heredia, PhD., MPH
The University of Texas Health Science Center, Houston
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 54.8 years STANDARD_DEVIATION 12 |
| Race/Ethnicity, Customized Chose not to answer | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 22 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 44 Participants |
| Race/Ethnicity, Customized Non-Hispanic White or Other | 6 Participants |
| Region of Enrollment United States | 31 Participants |
| Sex/Gender, Customized Chose not to answer | 1 Participants |
| Sex/Gender, Customized Female | 42 Participants |
| Sex/Gender, Customized Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 31 |
| other Total, other adverse events | 0 / 58 | 0 / 31 |
| serious Total, serious adverse events | 0 / 58 | 0 / 31 |
Outcome results
None listed