Food Insecurity Reduction & Strategy Team
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Nutrition program
Other interventionNutrition program with twice daily meal delivery up to 90 days post-discharge and food and diet education at discharge.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: SoC groupNo intervention 0 interventions
Group B: Nutrition program (Intervention)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Food insecurity at 60 -days post initial 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. 1. 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 2. Within the past 30 days, the food you bought just didn't last and you didn't have money to get more. (Categorical) 1. Never true, Sometimes true, Often true, Patient refused
Time frame
60 days from dischargeSecondary outcomes
1
Food insecurity at 30- and 90- days post post initial 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: 1. 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 2. Within the past 30 days, the food you bought just didn't last and you didn't have money to get more. (Categorical) 1. Never true, Sometimes true, Often true, Patient refused
Time frame
30-, and 90- days from discharge2
Measures of diabetes stress
Feeling overwhelmed by the demands of living with Diabetes measured using ordinal scale with range 1-6.
Time frame
30-,60-, and 90- days from discharge3
Measures of hypoglycemia
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+)
Time frame
30-,60-, and 90- days from discharge4
Measures of medication adherence
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.
Time frame
30-,60-, and 90- days from dischargeSponsors and contacts
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Source ClinicalTrials.gov