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NCT Number: NCT06329375

Food Insecurity Reduction & Strategy Team

This study seeks to address the multifaceted challenges posed by food disparities and their negative consequences on health outcomes, via a comprehensive community health intervention program. Study objectives include:

1. To describe the social-demographic and clinical factors associated with food insecurity in the hospitalized diabetic population. 2. To design, implement and evaluate a nutrition program targeting the hospitalized diabetic population. The investigators will prospectively randomize the target population into either a nutrition program (Intervention), or state-of-art standard of care (SOC) in a 4:1 ratio. Participants in the intervention group will be provided the following two resources in addition to SOC: 1) Enhanced access to nutritious food (twice daily meal delivery up to 90 days post-discharge) 2) Education at discharge and continuing outreach to enhance knowledge for better diet and food options. 3. To enhance community engagement and develop a systematic implementation plan for long-term roll-out of the nutrition program.

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Key information

Conditions

Diabetes Mellitus, Type 2 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Food Insecurity Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Medicine

Palo Alto, California, 94304, United States

Location status: Recruiting

Location contact

Neera Ahuja, MD

CONTACT

[email protected]

650-725-3515

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Type 1 or Type 2 Diabetes Mellitus
  • Admitted to Stanford Healthcare inpatient unit
  • Residence in California at time of enrollment
  • Positive Screening for Food Insecurity
  • On a Healthcare Plan covered by Mom's Meals.

Exclusion criteria

  • Plans to be discharged to a skilled nursing facility.
  • Patients who prefer a language for which a short-form consent is not available.
  • No Home Address
  • Pregnant Participants.
  • No access to refrigerator.

Treatment and study plan

Nutrition program

Other

Nutrition program with twice daily meal delivery up to 90 days post-discharge and food and diet education at discharge.

Primary outcomes

  1. Food insecurity at 60 -days post initial discharge

    Time frame: 60 days from discharge

    Primary outcome is whether the participant had food insecurity in the past 30 days, measured at 60-days post initial discharge by the Food Insecurity Reduction and Strategy Team (FIRST) Survey Instrument questionnaire.

    • Within the past 30 days, you were worried that your food would run out before you got the money to buy more. (Categorical)

    a. Never true, Sometimes true, Often true, Patient refused

    • Within the past 30 days, the food you bought just didn't last and you didn't have money to get more. (Categorical)
    • Never true, Sometimes true, Often true, Patient refused

Secondary outcomes

  1. Food insecurity at 30- and 90- days post post initial discharge

    Time frame: 30-, and 90- days from discharge

    The secondary outcome is whether the participant had food insecurity in the past 30 days, measured at 30-days and 90-days post initial discharge by the Food Insecurity Reduction and Strategy Team (FIRST) Survey Instrument questionnaire:

    • Within the past 30 days, you were worried that your food would run out before you got the money to buy more. (Categorical)

    a. Never true, Sometimes true, Often true, Patient refused

    • Within the past 30 days, the food you bought just didn't last and you didn't have money to get more. (Categorical)
    • Never true, Sometimes true, Often true, Patient refused

  2. Measures of diabetes stress

    Time frame: 30-,60-, and 90- days from discharge

    Feeling overwhelmed by the demands of living with Diabetes measured using ordinal scale with range 1-6.

  3. Measures of hypoglycemia

    Time frame: 30-,60-, and 90- days from discharge

    Whether ever having a low blood sugar (low glucose or hypoglycemic) reaction in the past 4 weeks and number of times having a low blood sugar (low glucose or hypoglycemic) reaction in the past 4 weeks. (ordinal scale: 0, 1-3, 4-7, 8+)

  4. Measures of medication adherence

    Time frame: 30-,60-, and 90- days from discharge

    Proportion of participants who missed their recommended diabetes medication in the past 7 days at least once and the mean number of days that the medication was missed in the past 7 days, measured using measured by participant self-report during survey response collection at 30-,60-, and 90-days post-discharge.

  5. Hospitalization

    Time frame: 30-,60-, and 90- days from discharge

    Proportion of participants having overnight hospitalizations in the past 30 days and mean number of nights with overnight hospitalizations in the past 30 days measured by participant self-report during survey response collection at 30-,60-, and 90-days post-discharge.

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Santiago, MD

CONTACT

[email protected]

(650) 725-5071

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Acronym: FIRST

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 25, 2024
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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