糖尿病の薬としての食品 (FAME-D)
Food is Medicine: 2 型糖尿病と食物不安を持つ個人のための医学的に調整された食事の無作為化臨床試験
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27599
- University of North Carolina at Chapel Hill
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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. |
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アクティブコンパレータ：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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Hemoglobin A1c at Month 6
時間枠：6 months
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Hemoglobin A1c Level |
6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Hemoglobin A1c at Month 12
時間枠：12 months
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Hemoglobin A1c Level |
12 months
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Food Insecurity Score at Month 6
時間枠：6 months
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Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity. |
6 months
|
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Food Insecurity Score at Month 12
時間枠：12 months
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Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity. |
12 months
|
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Health-Related Quality of Life Score as Assessed by PROMIS (Patient-Reported Outcomes Measurement Information System)-29 at Month 6
時間枠：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
|
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Health-Related Quality of Life Score as Assessed by PROMIS-29 at Month 12
時間枠：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
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Diabetes Distress Score as Assessed by PAID (Problem Areas in Diabetes)-11 at Month 6
時間枠：6 months
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Score ranges from 0-44 with higher scores indicating greater diabetes distress |
6 months
|
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Diabetes Distress Score as Assessed by PAID-11 at Month 12
時間枠：12 months
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Score ranges from 0-44 with higher scores indicating greater diabetes distress |
12 months
|
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Depressive Symptom Score at Month 6
時間枠：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
|
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Depressive Symptom Score at Month 12
時間枠：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
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Number of Participants With Self-reported Hypoglycemia at Month 6
時間枠：6 months
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Reported hypoglycemia between 0 and 6 months after randomization |
6 months
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Number of Participants With Self-reported Hypoglycemia at Month 12
時間枠：12 months
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Reported hypoglycemia between 6 and 12 months after randomization |
12 months
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Number of Participants With Self-reported Severe Hypoglycemia at Month 6
時間枠：6 months
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Reported severe hypoglycemia between 0 and 6 months after randomization |
6 months
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Number of Participants With Self-reported Severe Hypoglycemia at Month 12
時間枠：12 months
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Reported severe hypoglycemia between 6 and 12 months after randomization |
12 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Bodyweight at Month 6
時間枠：6 months
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Bodyweight measured in Kg |
6 months
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Bodyweight at Month 12
時間枠：12 months
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Bodyweight measured in Kg |
12 months
|
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Systolic Blood Pressure at Month 6
時間枠：6 months
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Systolic blood pressure in mm Hg |
6 months
|
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Systolic Blood Pressure at Month 12
時間枠：12 months
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Systolic blood pressure in mm Hg |
12 months
|
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Diastolic Blood Pressure at Month 6
時間枠：6 months
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Diastolic blood pressure measured in mm Hg |
6 months
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Diastolic Blood Pressure at Month 12
時間枠：12 months
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Diastolic blood pressure in mm Hg |
12 months
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Diet Quality Score at Month 6
時間枠：6 months
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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
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Diet Quality Score at Month 12
時間枠：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
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Probability of Cost-Related Medication Underuse at Month 6
時間枠：6 months
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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
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Probability of Cost-Related Medication Underuse at Month 12
時間枠：12 months
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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
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ARMS-D (Adherence to Refills and Medications Scale-Diabetes) Medication Adherence Score at Month 6
時間枠：6 months
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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
|
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ARMS-D Medication Adherence Score at Month 12
時間枠：12 months
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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
|
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Diabetes Self-Care Activities Medication Adherence Score at Month 6
時間枠：6 months
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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
|
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Diabetes Self-Care Activities Medication Adherence Score at Month 12
時間枠：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
|
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Food/Medication Trade-offs at Month 6
時間枠：6 months
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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
|
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Food/Medication Trade-offs at Month 12
時間枠：12 months
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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
|
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Housing Insecurity at Month 6
時間枠：6 months
|
Self-report of being worried about losing housing |
6 months
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Housing Insecurity Score at Month 12
時間枠：12 months
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Self-report of being worried about losing housing |
12 months
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Transportation Barriers at Month 6
時間枠：6 months
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Self-report of transportation barriers to attending medical appointments |
6 months
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Transportation Barriers at Month 12
時間枠：12 months
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Self-report of transportation barriers to attending medical appointments |
12 months
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Financial Strain
時間枠：6 months
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Self-report of financial strain |
6 months
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Financial Strain
時間枠：12 months
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Self-report of financial strain |
12 months
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Care Delay at Month 6
時間枠：6 months
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Self-report of delaying healthcare due to cost |
6 months
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Care Delay at Month 12
時間枠：12 months
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Self-report of delaying healthcare due to cost |
12 months
|
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Diet Self-Efficacy Score at Month 6
時間枠：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
|
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Diet Self-Efficacy Score at Month 12
時間枠：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
|
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Perceived Diabetes Self-Management Self-Efficacy Score at Month 6
時間枠：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
|
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Perceived Diabetes Self-Management Self-Efficacy Score at Month 12
時間枠：12 months
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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
|
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Stress Score at 6 Months
時間枠：6 months
|
Stress as assessed by perceived stress scale. Scores range from 0 to 40 with higher scores indicating higher perceived stress. |
6 months
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Stress Score at 12 Months
時間枠：12 months
|
Stress as assessed by perceived stress scale. Scores range from 0 to 40 with higher scores indicating higher perceived stress. |
12 months
|
協力者と研究者
協力者
捜査官
- 主任研究者：Seth Berkowitz, MD、UNC
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 20-2847
- R01DK125831 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
IPD 共有時間枠
Unless preempted by NIH policy, data will become available 12 months after publication of main findings, and be available for 60 months.
IPD 共有アクセス基準
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.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。