Jídlo jako lék na diabetes (FAME-D)
Jídlo je lék: Randomizovaná klinická studie lékařsky přizpůsobených jídel pro jednotlivce s diabetem 2. typu a potravinovou nejistotou
The investigators propose a single-site, open-label, Phase II, community-based randomized clinical explanatory trial to test the efficacy of a medically tailored meal (MTM) interventions for adults with food insecurity and T2DM (Type 2 Diabetes Mellitus). While the efficacy of MTM needs to be established, given the nature of the population served by MTM, it is important to design the study to enhance the external validity/generalizability of the findings as much as possible. The investigators will recruit 200 participants from the referral list of Community Servings, a Boston-based MTM provider, and randomly assign them to MTM (N=100) or usual care + monthly food subsidy (N=100). MTM intervention will consist of 6 months of weekly delivery of 10 ready-to-eat meals (approximately half an individual's weekly food intake), along with telephone-based lifestyle intervention that prepares participants for the post-treatment period. The usual care + food subsidy recipients will receive usual care along with 6 months of a $40/month food subsidy.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
Food insecurity, "lack of access to enough food for an active, healthy life", affects over 20% of the 30 million Americans with diabetes. Food insecurity is more common in racial/ethnic minorities and those with lower socioeconomic status. Moreover, food insecurity is associated with worse diabetes control and increased complications, even after adjusting for other risk factors. Food insecurity is a major contributor to disparities in diabetes outcomes.
Medically tailored meal (MTM) delivery programs are a promising intervention for individuals with diabetes and food insecurity. MTM programs deliver fully prepared food, tailored by a registered dietitian nutritionist to the specific medical needs of the individual, and provide education to help optimize disease self-management. Food insecurity is typically addressed with food subsidies-offering additional financial resources that can be spent on food. While both food subsidies and MTM can increase healthy food access, MTM can help overcome other barriers to diabetes management including lack of time, ability, knowledge, and skills needed to prepare appropriate meals. The use of these programs is often called 'food as medicine', as the purpose is to provide exactly the foods needed to help prevent diabetes complications. MTM are receiving increasing public attention, but there are, as of yet, no full-scale trials to test its effects on diabetes outcomes when compared with other food insecurity interventions.
Our research team has developed a medically tailored meal intervention that combines provision of healthy food, tailored to the specific nutrition needs of the individual, with an evidence-based lifestyle intervention that uses the period of meal delivery as springboard to improve diabetes self-management, both while receiving meals and after meal delivery is completed.
This study is an explanatory-focused randomized trial to assess a community-based medically tailored meals intervention (n=200). It will be conducted among diverse participants referred for medically tailored meals. Adults with type 2 diabetes, Hemoglobin A1c between 7.0% and 12.0%, and BMI ≥ 25 kg/m2 (≥ 23 kg/m2 for those with Asian ancestry) will be enrolled and randomly assigned to intervention or usual care + food subsidy. The intervention group will receive meal delivery and its attendant lifestyle intervention for 6 months, while the usual care + food subsidy group will receive a $40/month food subsidy, along with usual diabetes care.
Typ studie
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
North Carolina
-
Chapel Hill, North Carolina, Spojené státy, 27599
- University of North Carolina at Chapel Hill
-
-
Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Diagnosis of Type 2 Diabetes Mellitus
- Hemoglobin A1c ≥ 7.0% and ≤ 12.0% in last 12 months
- Experiencing food insecurity as indicated by 2-item Hunger Vital Sign
- English speaking
- BMI ≥25 kg/m^2 (≥ 23 kg/m^2 if self-report Asian ancestry)
- No plans to move from the area for at least 1 year
- Free living to the extent that participant has control over dietary intake
- Willing and able to provide written informed consent and participate in all study activities
Exclusion Criteria:
- Participant in diabetes, nutrition, or weight research intervention in last 12 months
- Another family member or household member is a study participant. Only one member of each household may take part in this study.
- Considering bariatric surgery in the next year or prior bariatric surgery in the past 2 years
- Lack of safe, stable residence and ability to store meals
- Lack of telephone
- Pregnancy/breastfeeding or intended pregnancy in the next year
- History of malignancy, other than non-melanoma skin cancer, unless surgically or medically cured > 5 years ago or in remission. Patients with localized prostate and breast cancer diagnosed during the course of routine screening will not be excluded.
- Advanced kidney disease (estimated creatinine clearance < 30 mL/min)
- Known drug or alcohol misuse in the past 2 years
- Known psychosis or major psychiatric illness that prevents participation with study activities
- Intermittent use of medications (e.g., oral or intravenous glucocorticoids) that are likely to affect blood sugar
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Experimentální: Medically Tailored Meal (MTM)
The Medically Tailored Meal (MTM) intervention consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-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. |
weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-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. |
|
Aktivní komparátor: Food Subsidy
As a comparison group, those not randomized to receive the MTM intervention will receive usual care provided by their clinicians not associated with the study, plus a food subsidy ($40/month) for 6 months, along with healthy eating information to guide use of that subsidy. |
$40/month food subsidy |
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Hemoglobin A1c at Month 6
Časové okno: 6 months
|
Hemoglobin A1c Level |
6 months
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Hemoglobin A1c at Month 12
Časové okno: 12 months
|
Hemoglobin A1c Level |
12 months
|
|
Food Insecurity Score at Month 6
Časové okno: 6 months
|
Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity. |
6 months
|
|
Food Insecurity Score at Month 12
Časové okno: 12 months
|
Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity. |
12 months
|
|
Health-Related Quality of Life Score as Assessed by PROMIS (Patient-Reported Outcomes Measurement Information System)-29 at Month 6
Časové okno: 6 months
|
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. These scores are then used to 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
Časové okno: 12 months
|
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. These scores are then used to calculate a PROMIS-Preference (PROPr score) (PROPr scores range from -0.022 (worst) to 1.0 (best)). |
12 months
|
|
Diabetes Distress Score as Assessed by PAID (Problem Areas in Diabetes)-11 at Month 6
Časové okno: 6 months
|
Score ranges from 0-44 with higher scores indicating greater diabetes distress |
6 months
|
|
Diabetes Distress Score as Assessed by PAID-11 at Month 12
Časové okno: 12 months
|
Score ranges from 0-44 with higher scores indicating greater diabetes distress |
12 months
|
|
Depressive Symptom Score at Month 6
Časové okno: 6 months
|
Depressive Symptoms as assessed by PROMIS SF (Short Form) 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
Časové okno: 12 months
|
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
|
|
Number of Participants With Self-reported Hypoglycemia at Month 6
Časové okno: 6 months
|
Reported hypoglycemia between 0 and 6 months after randomization |
6 months
|
|
Number of Participants With Self-reported Hypoglycemia at Month 12
Časové okno: 12 months
|
Reported hypoglycemia between 6 and 12 months after randomization |
12 months
|
|
Number of Participants With Self-reported Severe Hypoglycemia at Month 6
Časové okno: 6 months
|
Reported severe hypoglycemia between 0 and 6 months after randomization |
6 months
|
|
Number of Participants With Self-reported Severe Hypoglycemia at Month 12
Časové okno: 12 months
|
Reported severe hypoglycemia between 6 and 12 months after randomization |
12 months
|
Další výstupní opatření
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Bodyweight at Month 6
Časové okno: 6 months
|
Bodyweight measured in Kg |
6 months
|
|
Bodyweight at Month 12
Časové okno: 12 months
|
Bodyweight measured in Kg |
12 months
|
|
Systolic Blood Pressure at Month 6
Časové okno: 6 months
|
Systolic blood pressure in mm Hg |
6 months
|
|
Systolic Blood Pressure at Month 12
Časové okno: 12 months
|
Systolic blood pressure in mm Hg |
12 months
|
|
Diastolic Blood Pressure at Month 6
Časové okno: 6 months
|
Diastolic blood pressure measured in mm Hg |
6 months
|
|
Diastolic Blood Pressure at Month 12
Časové okno: 12 months
|
Diastolic blood pressure in mm Hg |
12 months
|
|
Diet Quality Score at Month 6
Časové okno: 6 months
|
Diet Quality as assessed by Brief Dietary Assessment Scale. The total score (range 0-50) is reported (higher score indicates better diet quality). The total score is comprised of 3 sections (or subscales) used to assess dietary patterns. 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. |
6 months
|
|
Diet Quality Score at Month 12
Časové okno: 12 months
|
Diet Quality as assessed by Brief Dietary Assessment Scale. The total score (range 0-50) is reported (higher score indicates better diet quality). The total score is comprised of 3 sections (or subscales) used to assess dietary patterns. 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. |
12 months
|
|
Probability of Cost-Related Medication Underuse at Month 6
Časové okno: 6 months
|
Any affirmative response to one or more of four cost-related medication underuse items derived from the Medical Expenditure Panel Survey. These items ask about not filling a prescription due to cost; skipping medication doses to save money; taking less medication than prescribed to save money; or 4) delaying filling a prescription to save money. Participants with ≥1 affirmative response were classified as having Cost-Related Medication Underuse (CRMU), and the reported values represent the estimated probability of CRMU. |
6 months
|
|
Probability of Cost-Related Medication Underuse at Month 12
Časové okno: 12 months
|
Any affirmative response to one or more of four cost-related medication underuse items derived from the Medical Expenditure Panel Survey. These items ask about not filling a prescription due to cost; skipping medication doses to save money; taking less medication than prescribed to save money; or 4) delaying filling a prescription to save money. Participants with ≥1 affirmative response were classified as having Cost-Related Medication Underuse (CRMU), and the reported values represent the estimated probability of CRMU. |
12 months
|
|
ARMS-D (Adherence to Refills and Medications Scale-Diabetes) Medication Adherence Score at Month 6
Časové okno: 6 months
|
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
Časové okno: 12 months
|
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
|
|
Diabetes Self-Care Activities Medication Adherence Score at Month 6
Časové okno: 6 months
|
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
Časové okno: 12 months
|
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
|
|
Food/Medication Trade-offs at Month 6
Časové okno: 6 months
|
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
Časové okno: 12 months
|
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
|
|
Housing Insecurity at Month 6
Časové okno: 6 months
|
Self-report of being worried about losing housing |
6 months
|
|
Housing Insecurity Score at Month 12
Časové okno: 12 months
|
Self-report of being worried about losing housing |
12 months
|
|
Transportation Barriers at Month 6
Časové okno: 6 months
|
Self-report of transportation barriers to attending medical appointments |
6 months
|
|
Transportation Barriers at Month 12
Časové okno: 12 months
|
Self-report of transportation barriers to attending medical appointments |
12 months
|
|
Financial Strain
Časové okno: 6 months
|
Self-report of financial strain |
6 months
|
|
Financial Strain
Časové okno: 12 months
|
Self-report of financial strain |
12 months
|
|
Care Delay at Month 6
Časové okno: 6 months
|
Self-report of delaying healthcare due to cost |
6 months
|
|
Care Delay at Month 12
Časové okno: 12 months
|
Self-report of delaying healthcare due to cost |
12 months
|
|
Diet Self-Efficacy Score at Month 6
Časové okno: 6 months
|
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
Časové okno: 12 months
|
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
|
|
Perceived Diabetes Self-Management Self-Efficacy Score at Month 6
Časové okno: 6 months
|
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
Časové okno: 12 months
|
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
|
|
Stress Score at 6 Months
Časové okno: 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
Časové okno: 12 months
|
Stress as assessed by perceived stress scale. Scores range from 0 to 40 with higher scores indicating higher perceived stress. |
12 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Seth Berkowitz, MD, UNC
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Dokončení studie (Aktuální)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- 20-2847
- R01DK125831 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Individual participant data 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 UNC.
Časový rámec sdílení IPD
Unless preempted by NIH policy, data will become available 12 months after publication of main findings, and be available for 60 months.
Kritéria přístupu pro sdílení IPD
Unless otherwise required by NIH policy, ability to deidentify data, plan for secure storage of data and agreement to protect participant privacy, relevant research question, to be assessed by study investigators.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- ICF
- ANALYTIC_CODE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .