Changing Health Through Food Support for Diabetes

NCT04959487 | Completed DMC

• 1 other identifier: R01DK124630
• Study Type: interventional
• Target: 281
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes; Food Insecurity

Keywords

Food security; Diabetes Mellitus; Food assistance

Outcome Measures

Primary Outcomes (2)

• 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

• Change in food insecurity severity from baseline to six months by study arm

  The US adult 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 10. Higher score indicates higher severity of food insecurity

  Baseline and six months

Secondary Outcomes (13)

• Change in the proportion of participants with low and very low food security

  Baseline and six months

• Change in proportion of participants with glucose control by study arm.

  Baseline and six months

• Change in systolic and diastolic blood pressure from baseline to six months

  Baseline and 6 months

• Change in medication adherence from baseline to six months by study arm

  Baseline and six months

• Acute health care utilization from baseline to six month by study arm

  Baseline and six months

Other Outcomes (2)

• Durability of HbA1c values from six months to twelve months in the intervention arm.

  Six and twelve months

• Durability in scores of food security from six to twelve months in the intervention arm.

  Six and twelve months

Study Arms (2)

Standard of care

NO INTERVENTION

Control participants will receive standard of care as offered by clinical partners to all T2DM patients, including referral to nutritional counseling, T2DM support groups, and participation in local diabetes self-management programs. Control participants are also often provided referral information for locally available food support services in the region that provide diabetes-appropriate foods. At the end of follow up, the control arm will receive similar services from POH to what the intervention arm received during the intervention, regardless POH eligibility criteria (6 months of DM-tailored food support to meet 67% of their daily requirements, video recording of the 4 CHEFS-DM education classes, and access to a POH dietitian at their request).

Food support and nutrition education

EXPERIMENTAL

The intervention entails two components: 1) food support that consists of weekly medically tailored meals and healthy groceries that on average covers 75% of daily energy requirements from baseline to six months and 2) diabetes-tailored nutritional education that consists of two individual counseling sessions with a Registered dietitian and four group education sessions.

Other: Food support; Other: Nutritional Counseling and education

Interventions

Food support OTHER

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.

Food support and nutrition education

Nutritional Counseling and education OTHER

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.

Food support and nutrition education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Project Open Hand: collaborator

Study Sites (1)

Project Open Hand

San Francisco, California, 94109, United States

Location

Related Publications (9)

• 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.

  PMID: 28097614 BACKGROUND

• 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.

  PMID: 26526255 BACKGROUND

• 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.

  PMID: 20592297 BACKGROUND

• 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.

  PMID: 23799677 BACKGROUND

• 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.

  PMID: 29608345 BACKGROUND

• 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.

  PMID: 31009050 BACKGROUND

• 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.

  PMID: 22210570 BACKGROUND

• 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.

  PMID: 21747017 BACKGROUND

• 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.

  PMID: 30939269 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Nutrition Assessment; Educational Status

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Socioeconomic Factors; Population Characteristics

Study Officials

• Kartika Palar, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single (Investigator) The investigator(s) reviewing the analyses of the data will be masked to whether participants were in the intervention or control arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants (n=440\*) will be randomized to the intervention (n=220\*) or control (n=220\*) arms, stratified by county (San Francisco vs. Alameda County) and poor diabetes control (A1c \< 9%, vs. ≥ 9%). The intervention consists of providing diabetes-tailored food support and nutritional education (two sessions of individual counseling and four session of in-group diabetes-tailored nutrition education sessions) over six months to patients with type 2 diabetes. \*Update: Due to COVID-era challenges, NIH approved changes to the study in January 2024 including a reduced sample size (at least n=246) and reduced measures and procedures to ease participant burden (see updated Protocol/SAP Version 2, Section 7, for details).

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 13, 2021
• Study Start: August 23, 2021
• Primary Completion: February 5, 2025
• Study Completion: June 12, 2025
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)