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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK124630 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Project Open Hand | OTHER |
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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.
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, blood draws, and semi structured interviews. 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).
*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 SAP Version 2, Section 7, for details).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 adult 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Durability in scores of food security from six to twelve months in the intervention arm. |
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):
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:
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| Name | Affiliation | Role |
|---|---|---|
| Kartika Palar, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Project Open Hand | San Francisco | California | 94109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28097614 | Background | 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. | |
| 26526255 | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 16, 2026 | |
| Reset | Apr 2, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 5, 2025 | Feb 19, 2025 | Prot_SAP_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 16, 2026 | Apr 2, 2026 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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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).
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Single (Investigator) The investigator(s) reviewing the analyses of the data will be masked to whether participants were in the intervention or control arm.
|
| 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. |
|
| 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 |
| 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 |
| 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 |
| Acute health care utilization from baseline to six month by study arm | Proportion of participants that used emergency health care (Emergency department or urgent care) during the 6 months of the study by study arm will be reported. | Baseline and six months |
| Hospital admissions from baseline to six months by study arm | Proportion of participants who were hospitalized at least once from baseline to six months of the study by study arms will be reported. | Baseline to six months |
| 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 |
| 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. The 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 |
| 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 |
| 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. The adequacy component of the HEI ranges from 0-60 and the moderation component ranges from 0-40 (both with higher score indicating better diet quality). Changes in the adequacy and moderation HEI-2015 score from baseline to six months by study arm will be reported. | Baseline and six months |
| 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 |
| 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 |
| 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 |
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 adult food security survey module from the USDA will be used. The score ranges from 0 to 10. Higher score indicates higher severity of food insecurity. |
| Six and twelve months |
| 20592297 | 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. |
| 23799677 | 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. |
| 29608345 | 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. |
| 31009050 | 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. |
| 22210570 | 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. |
| 21747017 | 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. |
| 30939269 | 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. |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |