Changing Health Through Food Support for Diabetes

Type 2 Diabetes Clinical Trial

— CHEFS-DM  

Official title:

Food is Medicine: Randomized Trial of Medically-Tailored Food Support for Diabetes Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04959487
• Other study ID #: R01DK124630
• Secondary ID: R01DK124630
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2021
• Est. completion date: August 30, 2025

Study information

• Verified date: July 2023
• Source: University of California, San Francisco
• Contact: Kartika Palar, PhD
• Phone: 415 226 6839
• Email: kartika.palar[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pragmatic randomized controlled trial (RCT) of Changing Health through Food Support for Diabetes (CHEFS-DM). This pragmatic RCT will leverage Project Open Hand's (POH) real-world programs to test the impact of a six month medically tailored food support and nutrition intervention ("CHEFS-DM") on glycemic control and other cardiometabolic outcomes, investigate the paths through which CHEFS-DM may durably improve health, and assess the economic value of the intervention to society.

Description:

CHEFS-DM is a six-month intervention providing a diabetes-tailored diet meeting approximately 75% of daily energy requirements and designed based on American Diabetes Association (ADA) guidelines, together with diabetes nutritional education provided by registered dietitians. In this pragmatic RCT, investigators propose to rigorously evaluate the intervention among 440 low-income adults with Type 2 Diabetes Mellitus (T2DM) recruited from networks of safety net clinics in San Francisco and Alameda counties, California.

Participants will be randomized 1:1 to the intervention (n=220) versus control (n=220), using a parallel design. The study aims are as follows:

Aim 1: To determine the impact of CHEFS-DM on glycemic control and other cardiometabolic outcomes.

Aim 2: To determine the impact of CHEFS-DM on intermediate outcomes that may mediate any impact of CHEFS-DM on T2DM health.

Participant will be followed for 6 months (control arm) and 12 months (intervention arm) with structured interviews, anthropometric assessments, 24-hour dietary recalls, blood pressure measurements, fasting blood draws, semi structured interviews, and medical record review. Follow-up will be broken up into two phases. From baseline to six months, researchers will implement the CHEFS-DM intervention and follow both intervention and control arm participants (n=440). After the end of the six-month follow-up, the intervention arm will transition to receiving standard POH services comprising 33% to 67% of daily energy requirements depending on health status, and will be followed for an additional six months, in order to assess the extent to which any health benefits are sustained at 12 months (n=220). Hence, the control arm will be followed for six months and participate in two sets of assessments (baseline and at six months), and the intervention arm will be followed for 12 months and participate in three sets of assessments (baseline, six months, and twelve months).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: August 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of T2DM confirmed by medical or laboratory records. For T2DM, any of the following criteria will be considered (from the American Diabetes Association):

• glycated hemoglobin (HbA1c) =6.5%, or

• fasting plasma glucose of =126, or

• a 2-hour plasma glucose level of 200 or higher during a 75 g oral glucose tolerance test, or

• a random plasma glucose of 200 or higher in patients with symptoms of hyperglycemia

• Age =18 years.

• Screening positive for food insecurity (at least one positive answer) in the previous 6 months assessed using the 6-item version of the US Household Food Security Survey Module (US Department of Agriculture), or has household income <200% of the federal poverty level.

• English or Spanish language fluency.

• Adequate cognitive and hearing capacity to consent and complete study measures.

• Reside in Alameda County or San Francisco County.

Exclusion Criteria:

• Type-1 diabetes mellitus

• Individuals with disorders known to affect the accuracy of the HbA1c measure (e.g., end stage renal disease and individuals with known hemoglobinopathies).

• Inability to attend the educational workshops.

• Inability to schedule baseline assessments and/or blood draw after repeated requests.

• Pregnant individuals, or individuals planning to get pregnant within 6 months, or are lactating, or are postpartum less than 6 months.

• Current POH clients, past POH clients who stopped services less than 6 months prior, or past or present participants in other POH medically tailored meals studies.

• Does not have access to food storage, including a refrigerator and freezer to safely keep food.

• Does not have access to facilities to reheat and prepare meals using Project Open Hand food.

• Anticipates moving out of study area of Alameda and San Francisco Counties in the next 6 months.

• Receives more than 1 meal per day from a free food support resource or agency.

• Allergic to or will not eat eggs, soy, wheat, nuts, seeds or seed oils, or other foods commonly included among ingredients in POH meals.

• Allergic to dairy products, or unable to tolerate any dairy products including milk, yogurt and cheese.

• Individual does not eat any or all of POH's meat meal options and will not eat the vegetarian POH meal option.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Food Insecurity
• Type 2 Diabetes

Intervention

Other:
• Food support
1. Diabetes-tailored food support. Project Open Hand will provide intervention participants six months of supplemental food support meeting on average 75% of their daily energy requirements. Food support will consist of a mix of meals tailored for T2DM, and T2DM-healthy groceries, consistent with American Diabetes Association (ADA) guidelines for diabetes healthy diets under the responsibility of a registered dietitian.
• Nutritional Counseling and education
2. Nutritional counseling and education: The registered dietitian will provide individual nutritional counseling two times (at baseline and month 5-6) during the intervention. In addition, group-based DM nutrition education will be conducted over four 1-hour-long sessions. The nutrition education will be conducted by a POH dietitian, and the curriculum will be consistent with published diabetes self- management education principles, utilizing effective strategies in lower wealth, lower literacy populations.

Locations

Country	Name	City	State
United States	Project Open Hand	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Project Open Hand

Country where clinical trial is conducted

United States, 

References & Publications (9)

Berkowitz SA, Terranova J, Hill C, Ajayi T, Linsky T, Tishler LW, DeWalt DA. Meal Delivery Programs Reduce The Use Of Costly Health Care In Dually Eligible Medicare And Medicaid Beneficiaries. Health Aff (Millwood). 2018 Apr;37(4):535-542. doi: 10.1377/hlthaff.2017.0999. — View Citation

Berkowitz SA, Terranova J, Randall L, Cranston K, Waters DB, Hsu J. Association Between Receipt of a Medically Tailored Meal Program and Health Care Use. JAMA Intern Med. 2019 Jun 1;179(6):786-793. doi: 10.1001/jamainternmed.2019.0198. — View Citation

Gurvey J, Rand K, Daugherty S, Dinger C, Schmeling J, Laverty N. Examining health care costs among MANNA clients and a comparison group. J Prim Care Community Health. 2013 Oct;4(4):311-7. doi: 10.1177/2150131913490737. Epub 2013 Jun 3. — View Citation

Marpadga S, Fernandez A, Leung J, Tang A, Seligman H, Murphy EJ. Challenges and Successes with Food Resource Referrals for Food-Insecure Patients with Diabetes. Perm J. 2019;23:18-097. doi: 10.7812/TPP/18-097. — View Citation

Palar K, Napoles T, Hufstedler LL, Seligman H, Hecht FM, Madsen K, Ryle M, Pitchford S, Frongillo EA, Weiser SD. Comprehensive and Medically Appropriate Food Support Is Associated with Improved HIV and Diabetes Health. J Urban Health. 2017 Feb;94(1):87-99. doi: 10.1007/s11524-016-0129-7. — View Citation

Seligman HK, Jacobs EA, Lopez A, Sarkar U, Tschann J, Fernandez A. Food insecurity and hypoglycemia among safety net patients with diabetes. Arch Intern Med. 2011 Jul 11;171(13):1204-6. doi: 10.1001/archinternmed.2011.287. No abstract available. — View Citation

Seligman HK, Jacobs EA, Lopez A, Tschann J, Fernandez A. Food insecurity and glycemic control among low-income patients with type 2 diabetes. Diabetes Care. 2012 Feb;35(2):233-8. doi: 10.2337/dc11-1627. Epub 2011 Dec 30. — View Citation

Seligman HK, Lyles C, Marshall MB, Prendergast K, Smith MC, Headings A, Bradshaw G, Rosenmoss S, Waxman E. A Pilot Food Bank Intervention Featuring Diabetes-Appropriate Food Improved Glycemic Control Among Clients In Three States. Health Aff (Millwood). 2015 Nov;34(11):1956-63. doi: 10.1377/hlthaff.2015.0641. — View Citation

Seligman HK, Schillinger D. Hunger and socioeconomic disparities in chronic disease. N Engl J Med. 2010 Jul 1;363(1):6-9. doi: 10.1056/NEJMp1000072. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Durability of HbA1c values from six months to twelve months in the intervention arm.	To evaluate durability of the HbA1c after the intervention ended, the change in HbA1c levels (%) from six months to twelve months in the intervention group will be reported.	Six and twelve months
Other	Durability in scores of food security from six to twelve months in the intervention arm.	To evaluate durability of food security after the intervention ended, the change in food insecurity scores from six months to twelve months in the intervention group will be reported. The US household food security survey module from the USDA will be used. The score ranges from 0 to 18 in households with children, and 0 to 10 in households without children. Higher score indicates higher severity of food insecurity.	Six and twelve months
Primary	Change in Hemoglobin A1c from baseline to six months by study arm	Change HbA1c levels (%) from baseline to six months by study arms.	Baseline and six months
Primary	Change in food insecurity severity from baseline to six months by study arm	The US household food security survey module from the US Department of Agriculture (USDA) will be used to assess the change in the food security scores from baseline to six months. The score ranges from 0 to 18 in households with children, and 0 to 10 in households without children. Higher score indicates higher severity of food insecurity	Baseline and six months
Secondary	Change in the proportion of participants with low and very low food security	Low and very low food security will be defined as 3 or more items answered affirmatively in the USDA's US household food security survey module. Change in proportion of participants with low or very low food security, from baseline to six months by intervention arms will be reported.	Baseline and six months
Secondary	Change in proportion of participants with glucose control by study arm.	Glucose control will be defined as HbA1c lower than 9%. The change from baseline to six months, in the proportion of participants with glucose control will be reported.	Baseline and six months
Secondary	Change in systolic and diastolic blood pressure from baseline to six months	Changes in the average of three repeated measurements of systolic and diastolic blood pressure (mm Hg) from baseline to six months by study arm.	Baseline and 6 months
Secondary	Change in medication adherence from baseline to six months by study arm	A single-item Rating Visual Analogue Scale will be used to evaluate diabetes medication adherence. Using the scale, participants self-report the adherence of medication ranging from 0% to 100%. The changes in diabetes medication adherence (percentage) from baseline to six months by study arms will be reported.	Baseline and six months
Secondary	Acute health care utilization from baseline to six month by study arm	Proportion of participants that used emergent health care (Emergency department or urgent care) during the 6 months of the study by study arm will be reported.	Baseline and six months
Secondary	Hospital admissions from baseline to six months by study arm	Proportion of participants that were hospitalized from baseline to six months of the study by study arms will be reported.	Baseline to six months
Secondary	Missed outpatient visits from baseline to six months by study arm	Proportion of participants that missed at least one outpatient visits from baseline to six months by study arms will be reported.	Baseline to six months
Secondary	Change in health-related quality of life scores from baseline to six months by study arm	The quality of life will be measured using the standardized 12-item short form health survey (SF-12v2). The SF-12v2 provides a summary score for physical and mental health. he transformed T score has a mean=50 and Standard Deviation=10, in which higher values means better health. The change in SF-12 T scores from baseline to six months by study arm will be reported.	Baseline and six months
Secondary	Change in body mass index (BMI) from baseline to six months by study arm	The average of three repeated measurements of weight and height will be obtained at baseline and at six months. The BMI will be calculated (weight (kg)/ (height (m)^2). Changes in in BMI values (kg/ m^2) from baseline to six months by study arm will be reported.	Baseline and six months
Secondary	Change in healthy eating index score 2015 (HEI-2015) from baseline to six months by study arm.	Dietary information using an automated self- administered 24-hour dietary recall instrument from the National Cancer Institute's (ASA24) will be collected. The HEI-2015 is a measure of diet quality which evaluates how well the food consumed aligns with the Dietary guidelines for American population. The HEI-2015 score ranges from 0-100 in which a higher score indicates better diet quality. Changes in the HEI-2015 score from baseline to six months by study arm will be reported.	Baseline and six months
Secondary	Change in depressive symptoms from baseline to six months by study arm	The 9-item Patient Health Questionnaire (PHQ-9) will be used to evaluate depressive symptoms. The PHQ-9 score ranges from 0 to 27, with higher scores indicating higher levels of depression. The change in PHQ-9 scores from baseline to six months by study arm will be reported.	Baseline and six months
Secondary	Change in diabetes distress scale from baseline to six months by study arm	The diabetes distress scale (DDS) has 17 items measuring frustration, anger, and discouragement associated with managing complex diabetes health-care directives. The DDS score ranges from 1 to 6, with higher scores indicating higher levels of distress. The change in diabetes distress scores from baseline to six months by study arms will be reported.	Baseline and six months
Secondary	Change in diabetes self-efficacy from baseline to six months by study arm	The 8-item Perceived Diabetes Self-Management (PDSM) scale will be used to assess confidence in one's ability to manage numerous self-care behaviors, including diet, and management of glucose. The PDSM scores ranges from 8 to 40, with higher scores indicating more confidence in self-managing their diabetes. The changes in the PDSM scores from baseline to six months by study arm will be reported.	Baseline and six months