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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK134463 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The goal of this clinical trial is to test whether the Food FARMacia intervention to reduce food insecurity is feasible and accepted among families with an infant age 6 to less than 18 months receiving pediatric primary care.
All participants will receive nutrition education and anticipatory guidance to support healthy meal preparation in addition to usual care.
Childhood obesity remains highly prevalent and originates early in life. Efficacious early life interventions to prevent childhood obesity are lacking, particularly among populations most burdened by childhood obesity. Food insecurity - defined as lack of enough food for an active, healthy life - may play key upstream roles in etiologies of obesity through establishment of unhealthy dietary patterns and stress-related metabolic perturbations. Household food insecurity during the first 24 months of life is a risk factor for later childhood obesity. Professional organizations recommend integration of household food insecurity screening into routine pediatric primary care. Yet, a critical gap exists in identification of efficacious clinical interventions to reduce food insecurity. Another gap exists in understanding relationships between food insecurity and etiologies of obesity. Food FARMacia is a clinically based mobile food pantry intervention developed to address the high prevalence of food insecurity among pediatric patients. No randomized trials of a clinically-based mobile food pantry intervention in pediatric primary care exist. To understand the role of food insecurity in etiologies of childhood obesity, efficacious interventions to reduce food insecurity are needed.
Household food insecurity during infancy is a risk factor for later childhood obesity. In this pilot and feasibility study, the investigators will randomly assign infants and their parent in households with food insecurity to either 1) the Food FARMacia mobile food pantry intervention with twice monthly food distributions and self-directed meal preparation support or 2) self-directed meal preparation support. Infants age 6 to <18 months who are patients at Stanford University/Stanford Health Care who screen positive for food insecurity will potentially be eligible participants for recruitment. Parents will be asked to respond to survey questions about health behaviors for themself and their infant at baseline and follow-up.
The investigators will measure vital signs (e.g., weight and height/length) for parents and infants at baseline and follow-up. The investigators will examine feasibility, acceptability, and satisfaction with the study procedures and intervention materials. The investigators will estimate intervention effects on infant weight characteristics and explore potential mediators such as reduction in food insecurity and changes in nutrition and other established obesity risk factors to inform a subsequent full-scale trial. If successful, results will lead to a full-scale trial to test effects of the intervention on food insecurity, nutrition, and infant growth. Eventually, these study results could transform clinical care to reduce childhood obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attention Control | Active Comparator | Participants will receive nutrition education and anticipatory guidance to support healthy meal preparation in addition to usual care. |
|
| Food FARMacia intervention | Experimental | Participants will enroll in the Food FARMacia program and receive groceries twice monthly for 6 months. They will also receive nutrition education and anticipatory guidance to support healthy meal preparation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food FARMacia Program | Behavioral | Twice monthly delivery of groceries with about 12 meals per household member for up to 4 household members for 6 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment feasibility | Completion of enrollment of 80 households within the study timeframe | 24 months |
| Retention Rate | At least 70% with complete follow-up visits at 6-month follow-up | 6 months |
| Attendance Rate (Proportion of food distributions attended/received) - Intervention Arm | At least 70% median attendance rate for twice monthly food distributions at 6-month follow-up | 6 months |
| Intervention Satisfaction - Intervention Arm | Average report of agree or strongly agree (mean score 4 or higher on a 5-point scale) with intervention satisfaction at 6-month follow-up | 6 months |
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Inclusion Criteria for Child:
Exclusion Criteria for Child:
Inclusion Criteria for Parent/Legal Guardian:
Exclusion Criteria for Parent/Legal Guardian:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Contact | 646-369-5048 | cropnutrition@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Woo Baidal, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Not yet recruiting | Stanford | California | 94305 | United States |
De-identified participant level data
Beginning 3 months after peer-reviewed publication and up to 36 months after publication.
Investigators who provide a proposal for data use that is approved by the study investigators. Information on submitting proposals and accessing data may be obtained by emailing the study PI and coordinator. A signed data use agreement will be required.
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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Participants will be randomized and assigned to enroll in the Food FARMacia program for the duration of the study period or to receive usual care.
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Participants will not be masked as they will be receiving twice monthly groceries if they are enrolled in the Food FARMacia program.
| Self-directed meal preparation support | Behavioral | Nutrition education and anticipatory guidance to support healthy meal preparation |
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| Columbia University Irving Medical Center | Recruiting | New York | New York | 10032 | United States |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |