Food As MedicinE for Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— FAME-D  

Official title:

Food is Medicine: A Randomized Clinical Trial of Medically Tailored Meals For Individuals With Type 2 Diabetes Mellitus and Food Insecurity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04828785
• Other study ID #: 20-2847
• Secondary ID: R01DK125831
• Status: Recruiting
• Phase: N/A
• Start date: July 2, 2021
• Est. completion date: January 2026

Study information

• Verified date: June 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Katharine Ricks, PhD
• Phone: 919-843-6637
• Email: kathier1[@]email.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• MTM
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.
• Food Subsidy
$40/month food subsidy

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Community Servings, Massachusetts General Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bodyweight at Month 6	Bodyweight measured in Kg	6 months
Other	Bodyweight at Month 12	Bodyweight measured in Kg	12 months
Other	Systolic Blood Pressure at Month 6	Systolic blood pressure in mm Hg	6 months
Other	Systolic Blood Pressure at Month 12	Systolic blood pressure in mm Hg	12 months
Other	Diastolic Blood Pressure at Month 6	Diastolic blood pressure measured in mm Hg	6 months
Other	Diastolic Blood Pressure at Month 12	Diastolic blood pressure in mm Hg	12 months
Other	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
Other	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
Other	Cost-Related Medication Underuse at Month 6	Any affirmative response to cost-related medication underuse items	6 months
Other	Cost-Related Medication Underuse at Month 12	Any affirmative response to cost-related medication underuse items	12 months
Other	ARMS-D (Adherence to Refills and Medications Scale-Diabetes) 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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Housing Insecurity at Month 6	Self-report of being worried about losing housing	6 months
Other	Housing Insecurity Score at Month 12	Self-report of being worried about losing housing	12 months
Other	Transportation Barriers at Month 6	Self-report of transportation barriers to attending medical appointments	6 months
Other	Transportation Barriers at Month 12	Self-report of transportation barriers to attending medical appointments	12 months
Other	Financial Strain	Self-report of financial strain	6 months
Other	Financial Strain	Self-report of financial strain	12 months
Other	Care Delay at Month 6	Self-report of delaying healthcare due to cost	6 months
Other	Care Delay at Month 12	Self-report of delaying healthcare due to cost	12 months
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	Hemoglobin A1c at Month 6	Hemoglobin A1c Level	6 months
Secondary	Hemoglobin A1c at Month 12	Hemoglobin A1c Level	12 months
Secondary	Food Insecurity Score at Month 6	Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.	6 months
Secondary	Food Insecurity Score at Month 12	Food Insecurity Score. Score ranges from 0-10, with higher scores indicating greater food insecurity.	12 months
Secondary	Health-Related Quality of Life Score as assessed by PROMIS (Patient-Reported Outcomes Measurement Information System)-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 we will also calculate a PROMIS-Preference (PROPr score) (PROPr scores range from -0.022 (worst) to 1.0 (best)).	6 months
Secondary	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 we will also calculate a PROMIS-Preference (PROPr score) (PROPr scores range from -0.022 (worst) to 1.0 (best)).	12 months
Secondary	Diabetes Distress Score as assessed by PAID (Problem Areas in Diabetes)-11 at Month 6	Score ranges from 11-55 with higher scores indicating greater diabetes distress	6 months
Secondary	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
Secondary	Depressive Symptom Score at Month 6	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
Secondary	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
Secondary	Frequency of self-reported hypoglycemia at Month 6	Categorized by number of episodes on prior 3 months	6 months
Secondary	Frequency of self-reported hypoglycemia at Month 12	Categorized by number of episodes on prior 3 months	12 months
Secondary	Frequency of self-reported severe hypoglycemia at Month 6	Categorized by number of episodes on prior 3 months	6 months
Secondary	Frequency of self-reported severe hypoglycemia at Month 12	Categorized by number of episodes on prior 3 months	12 months