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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK127365 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Community Servings | OTHER |
| Massachusetts General Hospital | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This is a single-site, open-label, Phase II, community-based randomized controlled explanatory trial to test the efficacy of a medically tailored meal + intensive lifestyle intervention (MTM + ILI) intervention for adults with food insecurity, HIV, and T2DM or high risk of T2DM, compared with a group that receives usual MTM.
In contemporary practice for people with HIV, type 2 diabetes mellitus (T2DM) has become an important comorbidity. T2DM is 1.5 times more common in people with HIV than the general population. Among those with T2DM, people with HIV have greater risk for weight gain, lower diet quality, and higher hemoglobin A1c. All of this puts people with HIV and T2DM at substantial risk for complications, including chronic kidney disease, cardiovascular disease, and premature mortality. Food insecurity, "lack of access to enough food for an active, healthy life", is a major contributor to this risk. Food insecurity is 2 to 3 times more common among people with HIV than the general population. Food insecurity is associated with both worse T2DM control and more T2DM complications.
Medically tailored meal home delivery programs relieve food insecurity for people with HIV. Medically tailored meals emerged to treat food insecurity among those with AIDS in the 1990's. Medically tailored meal programs deliver fully prepared meals, tailored by a registered dietitian to an individual's medical needs. Although HIV care has changed, medically tailored meal interventions for people with HIV have not kept pace. Most medically tailored meal programs do not provide the intensive lifestyle intervention needed to counter the health threats seen in modern HIV care. These threats include the metabolic effects of anti-retroviral medications, chronic inflammation, aging, and obesogenic environments. For these reasons, it is critical to test new models of medically tailored meal for people with HIV.
The investigators has developed a medically tailored meal intervention that combines meal delivery with an evidence-based lifestyle intervention designed to improve weight loss and diabetes self-management. The goal for this project is to test whether this medically tailored meal intervention can lead to improvements in weight, hemoglobin A1c, and in patient-reported outcomes such as food insecurity, quality of life, and diabetes distress, compared with a standard medically tailored meal intervention.
Thus, the investigators propose a randomized comparative effectiveness trial to assess a community-based medically tailored meals intervention (n=200). It will be conducted among diverse participants with HIV and T2DM or high risk for T2DM, referred for medically tailored meals. Adults with hemoglobin A1c less than 12.0%, and BMI ≥ 23 kg/m^2 will be enrolled and randomly assigned to intervention or standard medically tailored meals. The intervention group will receive meal delivery and intensive lifestyle intervention for 12 months, while the comparison group will receive meal delivery along with standard nutrition education for 12 months. Outcomes will be assessed at 6, 12, and 18 months. The primary outcome is weight at 6 months. Secondary outcomes include hemoglobin a1c, food security, quality of life, and diabetes distress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medically Tailored Meal (MTM) + Intensive Lifestyle Intervention (ILI) | Experimental | The Medically Tailored Meal (MTM) + Intensive Lifestyle Intervention (ILI) consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 20-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention. |
|
| Standard MTM | Active Comparator | The Standard Medically Tailored Meal (MTM) intervention (ILI) consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and an initial consultation with a dietitian. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MTM + ILI | Behavioral | Weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 20-session telephone lifestyle intervention change program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bodyweight at Month 6 | Bodyweight measured in Kg | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bodyweight at Month 12 | Bodyweight measured in Kg | 12 months |
| Bodyweight at Month 18 | Bodyweight measured in Kg | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Food Insecurity Score at Month 6 | Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity. | 6 Months |
| Food Insecurity Score at Month 12 | Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity. |
Inclusion Criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katharine Ricks, PhD | Contact | 919-843-6637 | kathier1@email.unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Seth A Berkowitz, MD, MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
Individual participant data (IPD) that can be deidentified without risk of confidentiality breach will shared upon written request made to study investigators. In addition, all NIH policies regarding data sharing will be followed. Deidentified individual data that supports the results will be shared provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill (UNC).
Unless preempted by NIH policy, data will become available 12 months after publication of main findings, and be available for 60 months.
Unless otherwise required by NIH policy, ability to deidentify data, plan for secure storage of data and agreement to protect participant privacy, and relevant research question, to be assessed by study investigators.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D015658 | HIV Infections |
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C099588 | myotubularin |
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Participants will be assigned in 1:1 ratio to one of two intervention arms
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Owing to the nature of the intervention, participants, providers, and many study staff will know to which group individual participants have been randomized. However, efforts will be made to keep the study statistician and outcome assessors blinded to randomization group during the course of the trial.
| Standard MTM | Behavioral | Weekly home meal delivery; an explanation of the medical tailoring of the meals; and an initial consultation with a dietitian |
|
| Hemoglobin A1c at Month 6 | Hemoglobin A1c Level | 6 months |
| Hemoglobin A1c at Month 12 | Hemoglobin A1c Level | 12 months |
| Hemoglobin A1c at Month 18 | Hemoglobin A1c Level | 18 months |
| Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at Month 6 | The PROMIS-29 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms. Will report overall score and scores for each domain. From these data will also calculate a PROMIS-Preference (PROPr score) (PROPr scores range from -0.022 (worst) to 1.0 (best)). | 6 months |
| Health-Related Quality of Life Score as assessed by PROMIS-29 at Month 12 | The PROMIS-29 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms. Will report overall score and scores for each domain. From these data will also calculate a PROMIS-Preference (PROPr score) (PROPr scores range from -0.022 (worst) to 1.0 (best)). | 12 months |
| Health-Related Quality of Life Score as assessed by PROMIS-29 at Month 18 | The PROMIS-29 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms. Will report overall score and scores for each domain. From these data will also calculate a PROMIS-Preference (PROPr score) (PROPr scores range from -0.022 (worst) to 1.0 (best)). | 18 months |
| Depressive Symptom Score at Month 6 | Depressive Symptoms as assessed by PROMIS Short Form (PROMIS SF) v1.0 - Depression 4a. Raw scores are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on depression indicates more severe depressive symptoms. | 6 months |
| Depressive Symptom Score at Month 12 | Depressive Symptoms as assessed by PROMIS SF v1.0 - Depression 4a. Raw scores are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on depression indicates more severe depressive symptoms. | 12 months |
| Depressive Symptom Score at Month 18 | Depressive Symptoms as assessed by PROMIS SF v1.0 - Depression 4a. Raw scores are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on depression indicates more severe depressive symptoms. | 18 months |
| Diabetes Distress Score as assessed by Problem Areas in Diabetes (PAID)-11 at Month 6 | Score ranges from 11-55 with higher scores indicating greater diabetes distress | 6 months |
| Diabetes Distress Score as assessed by PAID-11 at Month 12 | Score ranges from 11-55 with higher scores indicating greater diabetes distress | 12 months |
| Diabetes Distress Score as assessed by PAID-11 at Month 18 | Score ranges from 11-55 with higher scores indicating greater diabetes distress | 18 months |
| 12 Months |
| Food Insecurity Score at Month 18 | Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity. | 18 Months |
| Systolic Blood Pressure at Month 6 | Systolic blood pressure in mm Hg | 6 Months |
| Systolic Blood Pressure at Month 12 | Systolic blood pressure in mm Hg | 12 Months |
| Systolic Blood Pressure at Month 18 | Systolic blood pressure in mm Hg | 18 Months |
| Diastolic Blood Pressure at Month 6 | Diastolic blood pressure in mm Hg | 6 Months |
| Diastolic Blood Pressure at Month 12 | Diastolic blood pressure in mm Hg | 12 Months |
| Diastolic Blood Pressure at Month 18 | Diastolic blood pressure in mm Hg | 18 Months |
| Diet Quality Score at Month 6 | Diet Quality as assessed by Brief Dietary Assessment Scale. This score is comprised of 3 sections (or subscales) used to assess dietary patterns. Subscales are scored independently. The subscales are: Vegetables, Fruit, Whole Grains, and Beans subscale (range 0 - 20), Drinks, Desserts, Snacks, Eating Out, and Salt subscale (range 0- 20), and Fish, Meat, Poultry, Dairy, and Eggs subscale (range 0-10): Total score equals the sum of the 3 subscales. For subscales and total score, higher scores indicates better diet quality. | 6 months |
| Diet Quality Score at Month 12 | Diet Quality as assessed by Brief Dietary Assessment Scale. This score is comprised of 3 sections (or subscales) used to assess dietary patterns. Subscales are scored independently. The subscales are: Vegetables, Fruit, Whole Grains, and Beans subscale (range 0 - 20), Drinks, Desserts, Snacks, Eating Out, and Salt subscale (range 0- 20), and Fish, Meat, Poultry, Dairy, and Eggs subscale (range 0-10): Total score equals the sum of the 3 subscales. For subscales and total score, higher scores indicates better diet quality. | 12 months |
| Diet Quality Score at Month 18 | Diet Quality as assessed by Brief Dietary Assessment Scale. This score is comprised of 3 sections (or subscales) used to assess dietary patterns. Subscales are scored independently. The subscales are: Vegetables, Fruit, Whole Grains, and Beans subscale (range 0 - 20), Drinks, Desserts, Snacks, Eating Out, and Salt subscale (range 0- 20), and Fish, Meat, Poultry, Dairy, and Eggs subscale (range 0-10): Total score equals the sum of the 3 subscales. For subscales and total score, higher scores indicates better diet quality. | 18 months |
| Cost-Related Medication Underuse at Month 6 | Any affirmative response to cost-related medication underuse items | 6 months |
| Cost-Related Medication Underuse at Month 12 | Any affirmative response to cost-related medication underuse items | 12 months |
| Cost-Related Medication Underuse at Month 18 | Any affirmative response to cost-related medication underuse items | 18 months |
| Adherence to Refills and Medications Scale-Diabetes (ARMS-D) Medication Adherence Score at Month 6 | Medication Adherence as assessed by 7-item ARMS-D scale. Scores range from 7 to 28, with higher scores indicating more problems with adherence. | 6 months |
| ARMS-D Medication Adherence Score at Month 12 | Medication Adherence as assessed by 7-item ARMS-D scale. Scores range from 7 to 28, with higher scores indicating more problems with adherence. | 12 months |
| ARMS-D Medication Adherence Score at Month 18 | Medication Adherence as assessed by 7-item ARMS-D scale. Scores range from 7 to 28, with higher scores indicating more problems with adherence. | 18 months |
| Diabetes Self-Care Activities Medication Adherence Score at Month 6 | Medication Adherence as assessed by 1-item summary of diabetes self-care activities measure. Scores range from 0-7 with higher scores indicating better adherence. | 6 months |
| Diabetes Self-Care Activities Medication Adherence Score at Month 12 | Medication Adherence as assessed by 1-item summary of diabetes self-care activities measure. Scores range from 0-7 with higher scores indicating better adherence. | 12 months |
| Diabetes Self-Care Activities Medication Adherence Score at Month 18 | Medication Adherence as assessed by 1-item summary of diabetes self-care activities measure. Scores range from 0-7 with higher scores indicating better adherence. | 18 months |
| Diet Self-Efficacy Score at Month 6 | Diet Self-Efficacy as assessed by cardiac diet self-efficacy scale. Scores range from 16 to 80 with higher scores indicating greater self-efficacy. | 6 months |
| Diet Self-Efficacy Score at Month 12 | Diet Self-Efficacy as assessed by cardiac diet self-efficacy scale. Scores range from 16 to 80 with higher scores indicating greater self-efficacy. | 12 months |
| Diet Self-Efficacy Score at Month 18 | Diet Self-Efficacy as assessed by cardiac diet self-efficacy scale. Scores range from 16 to 80 with higher scores indicating greater self-efficacy. | 18 months |
| Perceived Diabetes Self-Management Self-Efficacy Score at Month 6 | Diabetes Self-Efficacy as assessed by Perceived Diabetes Self-Management Scale. Scores range from 8 to 40 with higher scores indicating greater self-efficacy | 6 months |
| Perceived Diabetes Self-Management Self-Efficacy Score at Month 12 | Diabetes Self-Efficacy as assessed by Perceived Diabetes Self-Management Scale. Scores range from 8 to 40 with higher scores indicating greater self-efficacy | 12 months |
| Perceived Diabetes Self-Management Self-Efficacy Score at Month 18 | Diabetes Self-Efficacy as assessed by Perceived Diabetes Self-Management Scale. Scores range from 8 to 40 with higher scores indicating greater self-efficacy | 18 months |
| Stress Score at 6 months | Stress as assessed by perceived stress scale. Scores range from 0 to 40 with higher scores indicating higher perceived stress. | 6 months |
| Stress Score at 12 months | Stress as assessed by perceived stress scale. Scores range from 0 to 40 with higher scores indicating higher perceived stress. | 12 months |
| Stress Score at 18 months | Stress as assessed by perceived stress scale. Scores range from 0 to 40 with higher scores indicating higher perceived stress. | 18 months |
| Food/Medication Trade-offs at Month 6 | Single item-indicators of trading off medication for food or food for medication. An affirmative response indicates the presence of a trade-off. | 6 months |
| Food/Medication Trade-offs at Month 12 | Single item-indicators of trading off medication for food or food for medication. An affirmative response indicates the presence of a trade-off. | 12 months |
| Food/Medication Trade-offs at Month 18 | Single item-indicators of trading off medication for food or food for medication. An affirmative response indicates the presence of a trade-off. | 18 months |
| Cluster of Differentiation 4 (CD4+) Count at Month 6 | CD4+ Count | 6 Months |
| Self-Reported CD4+ Count at Month 6 | Self-Reported CD4+ Count | 6 Months |
| Self-Reported CD4+ Count at Month 12 | Self-Reported CD4+ Count | 12 Months |
| Self-Reported CD4+ Count at Month 18 | Self-Reported CD4+ Count | 18 Months |
| HIV Viral Load at Month 6 | HIV Viral Load | 6 Months |
| Self-Reported HIV Viral Load at Month 6 | Self-Reported HIV Viral Load | 6 Months |
| Self-Reported HIV Viral Load at Month 12 | Self-Reported HIV Viral Load | 12 Months |
| Self-Reported HIV Viral Load at Month 18 | Self-Reported HIV Viral Load | 18 Months |
| C-Reactive Protein (CRP) at Month 6 | C-Reactive Protein | 6 months |
| D004700 | Endocrine System Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |