Food Insecurity, Social Determinants of Health (NCT06784310) | Clinical Trial Compass
CompletedNot Applicable
Food Insecurity, Social Determinants of Health
United States56 participantsStarted 2025-04-01
Plain-language summary
Food is Medicine for the whole will test an intervention which provides medically tailored meals, or grocery voucher cards, or a combination of these food and nutrition resources to a caregiver and children living in the household. The study will examine how providing healthy tailored food and nutrition services can improve health outcomes, such as blood pressure and cholesterol levels.
Who can participate
Age range6 Years – 64 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have at least one child ages 6-17, inclusive, living in the household with the adult at least 50% of the time
* Diagnosis of stage 3 or 4 Hypertension in last 12 months, or diagnosis of T2DM in the last 12 months
* Experiencing food insecurity as indicated by 2-item Hunger Vital Sign
* English speaking
* No plans to move from the area for at least 1 year
* Willing and able to accept text messages
* Free living to the extent that participant has control over dietary intake
* Willing and able to provide written informed consent and participate in all study activities.
Exclusion Criteria:
* Participant in diabetes, nutrition, or weight research intervention in last 12 months
* Considering bariatric surgery in the next year or prior bariatric surgery
* Lack of safe, stable residence and ability to store meals
* Lack of telephone which can receive text messages
* Pregnancy/breastfeeding or intended pregnancy in the next year
* History of malignancy, other than non-melanoma skin cancer, unless surgically or medically cured \> 5 years ago or in remission
* Advanced kidney disease (estimated creatinine clearance \< 30 mL/min)
* Known drug or alcohol misuse in the past 2 years
* Known psychosis or major psychiatric illness that prevents participation with study activities
* Intermittent use of medications (e.g., oral or intravenous glucocorticoids) that are likely to affect blood sugar.
What they're measuring
1
Change in body mass index (BMI) percentile - child
Timeframe: Baseline, post intervention (week 12), and month 6
2
Change in body mass index percentile - adult
Timeframe: Baseline, post intervention (week 12), and month 6
3
Change in systolic blood pressure - child
Timeframe: Baseline, post intervention (week 12), and month 6
4
Change in diastolic blood pressure - child
Timeframe: Baseline, post intervention (week 12), and month 6
5
Change in systolic blood pressure - adult
Timeframe: Baseline, post intervention (week 12), and month 6
6
Change in diastolic blood pressure - adult
Timeframe: Baseline, post intervention (week 12), and month 6
7
Change in Hemoglobin A1c - child
Timeframe: Baseline, post intervention (week 12), and month 6