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| Name | Class |
|---|---|
| Stanford University | OTHER |
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This study will look at the effects of providing medically tailored meals (MTMs) to people with heart disease for twelve weeks. The primary outcome of the study is the quality of the diet being consumed in week 12 of the study, as determined by the "Healthy Eating Index."
This study will look at the effects of providing medically tailored meals (MTMs) to people with heart disease for twelve weeks. Sixty adults with heart failure will be recruited from the San Diego and San Francisco Bay Area of California. They will be randomly assigned to two groups: 1) a group that receives 15 "medically tailored meals" plus snacks each week for 12 weeks, 2) a group that receives 14 "medically tailored meals" each week for 12 weeks. The primary outcome of the study is the quality of the diet being consumed in week 12 of the study, as determined by the "Healthy Eating Index". Many other secondary outcomes will be assessed including both qualitative factors (e.g., satisfaction, preferences, adherence) and quantitative clinically measures (e.g., blood cholesterol, blood pressure, weight).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15 Medically Tailored Meals (MTM) + snacks | Experimental | Participants will receive 15 medically tailored meals (MTM) per week, plus snacks, for 12 weeks. |
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| 14 Medically Tailored Meals (MTM) | Experimental | Participants will receive 14 medically tailored meals (MTM) per week for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 15 Medically Tailored Meals (MTM) per week | Other | 15 heart-healthy medically tailored meals delivered to participants each week. Meals include breakfast, lunch, dinner, and snack to consume Monday-Friday. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in diet quality at Week 12, as determined by the Healthy Eating Index (HEI) | HEI will be used to determine diet quality based on dietary recall data collected via Nutrition Data System for Research (NDSR) software. HEI scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations and dietary patterns published in the Dietary Guidelines for Americans. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Participant satisfaction with delivery of medically tailored meals for individuals with heart failure | Participant satisfaction will be assessed using a study-specific self-administered questionnaire that uses a 5-point Likert scale. Participants will be asked to rate their experiences with multiple aspects of the provided study meals (including taste, variety, quality, cultural appropriateness, amount of food, visual appeal, and delivery) from "poor" to "excellent". |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheryl Anderson, PhD, MPH, MS | UC San Diego | Principal Investigator |
| Christopher Gardner, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | La Jolla | California | 92093 | United States | ||
| Stanford University |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C099588 | myotubularin |
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By the nature of the dietary intervention, it is impossible to blind participants to study arm assignment. However, research staff collecting outcome data, apart from dietary adherence data, will remain blinded to participants' assigned study arm throughout data collection. Additionally, the statistician(s) analyzing data for efficacy of the intervention will use a dataset with study arm masked in order to remain blinded to the assigned intervention for the final analysis.
| 14 Medically Tailored Meals (MTM) per week | Other | 14 heart-healthy medically tailored meals delivered to participants each week. Meals include lunch and dinner to consume Monday-Sunday. |
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| Week 4 and Week 12 |
| Dietary adherence to meal assignment using daily food diaries and 24-hour dietary recalls | Participants' qualitative daily food diaries and quantitative dietary analyses based on interviewer-assisted dietary recalls using Nutrition Data System for Research (NDSR) software will be combined to determine the proportion of provided meals that participants consumed. | Baseline and Weeks 4, 6, 8, and 12 |
| Change in reported access to healthy foods as assessed by the Food Consumption Score (FCS) | The Food Consumption Score aggregates household-level data on the diversity and frequency of food groups consumed over the previous seven days, which is then weighted according to the relative nutritional value of the consumed food groups. The Food Consumption Score scale ranges from 0-112, with higher scores indicating better food consumption status. | Baseline, Week 12, and Week 24 |
| Change in reported food security as assessed by the Food Insecurity Experience Scale (FIES) | The Food Insecurity Experience Scale (FIES) consists of eight questions regarding people's access to adequate food during the last 30 days. The raw score scale ranges from 0-8, with a higher score indicating more food insecurity experiences. Scale items are analyzed together as a scale, not be reported in terms of percent of positive responses to individual questions. The classifications of food insecurity severity based on responses may be described as mild, moderate, and severe food insecurity. | Baseline, Week 12, Week 24 |
| Change in reported food security as assessed by the Short Form of the U.S. Adult Food Security Survey Module | The 6-item survey collects information about whether participants had access to and were able to afford enough food in the last 30 days. The survey allows for stratification of participants into one of four food security categories based on their responses - high food security, marginal food security, low food security, and very low food security. The raw score scale ranges from 0 - 6, with a higher score indicating lower food security. | Baseline, Week 12, Week 24 |
| Change in mean blood pressure | Mean blood pressure will be calculated based on 3 consecutive readings in the research clinic during each in-person study visit. | Baseline and Week 12 |
| Change in blood lipid levels | Baseline and Week 12 |
| Change in Hemoglobin A1C (HbA1C) levels | Baseline and Week 12 |
| Change in weight | Weight will be measured by study personnel at each in-person study visit. | Baseline and Week 12 |
| Stanford |
| California |
| 94305 |
| United States |