[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06051591":3,"trial-entities:NCT06051591":134,"trial-summary:NCT06051591":137},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":22,"primary_purpose":13,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":55,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":91,"locations":95,"central_contacts":125,"overall_officials":130,"references":132,"see_also_links":133},"NCT06051591","76726","Food FARMacia: Reducing Childhood Obesity in Households With Food Insecurity","RECRUITING","2027-03-31","2026-03","2026-03-05","2023-12-01","Stanford University","OTHER",true,"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.\n\nAll 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.\n\nHousehold 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 \\\u003C18 months who are patients at Stanford University\u002FStanford 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.\n\nThe investigators will measure vital signs (e.g., weight and height\u002Flength) 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.",[18],"Nutrition, Healthy",[20,21],"Childhood Obesity","Food Insecurity","INTERVENTIONAL",[24],"NA",{"count":26,"type":27},80,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Food FARMacia Program","Twice monthly delivery of groceries with about 12 meals per household member for up to 4 household members for 6 months.",[34],"Food FARMacia intervention",{"type":30,"name":36,"description":37,"armGroupLabels":38},"Self-directed meal preparation support","Nutrition education and anticipatory guidance to support healthy meal preparation",[39,34],"Attention Control",[41,45,49,52],{"measure":42,"description":43,"timeFrame":44},"Recruitment feasibility","Completion of enrollment of 80 households within the study timeframe","24 months",{"measure":46,"description":47,"timeFrame":48},"Retention Rate","At least 70% with complete follow-up visits at 6-month follow-up","6 months",{"measure":50,"description":51,"timeFrame":48},"Attendance Rate (Proportion of food distributions attended\u002Freceived) - Intervention Arm","At least 70% median attendance rate for twice monthly food distributions at 6-month follow-up",{"measure":53,"description":54,"timeFrame":48},"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",[],"ALL","6 Months",null,false,{"inclusion":61,"exclusion":75,"raw_text":90},[62,63,64,65,66,67,68,69,70,71,72,73,74],"Age 6 to \\\u003C 18 months at enrollment","Born gestational age 37 weeks or later without evidence of undernutrition at routine health care visits","In household with food insecurity at time of screening phone call based on an affirmative response on the 2-item Hunger Vital Signs™ screening tool","Primary pediatric care patient at Stanford University\u002FStanford Health Care Network","Planned continuation of primary pediatric care at Stanford University\u002FStanford Health Care","Living in a community setting (not inpatient or living in a nursing\u002Flong-term care setting) with a caretaker enrolled in this study","Primary caretaker of infant eligible for study and with planned enrollment in this study","Age 18 years or older","Ability to respond to questions in English and\u002For Spanish","Willing for self and infant to be randomized into a RCT and complete all study components","Gives permission to receive messages to their mobile device, email, and or place of residence","Gives permission to complete all study procedures for self and infant","Capable of providing informed consent for self and infant",[76,77,78,79,80,81,82,83,84,85,86,87,88,89],"Gestational age \\\u003C 37 weeks","Small-for-gestational age at birth (birth weight for gestational age less than 10th percentile)","Weight-for-length \\\u003C 3rd percentile","Body Mass Index \\\u003C 5th percentile for age and sex","Children in household previously enrolled in this study or the Food FARMacia program","Conditions that substantially interfere with growth or mobility (e.g., complex congenital heart disease, cystic fibrosis)","Children with special diets (e.g., tyrosinemia, enteral tube feeding)","Children with chronic diseases that interfere with nutrition and growth as determined by investigators","Pregnancy at baseline visit because of unique nutritional needs","Age \\\u003C 18 years at baseline because of unique developmental differences of adolescents and New York State regulations","Inability to complete study visits or intervention components","Unwillingness or inability to commit to a 6-month research study for self or infant","Unable to give informed consent","Underlying disease\u002Ftreatment that might interfere with participation in\u002Fcompletion of the study (e.g., significant gastrointestinal conditions, major psychiatric disorders, and others at the discretion of the study clinician)","Inclusion Criteria for Child:\n\n* Age 6 to \\\u003C 18 months at enrollment\n* Born gestational age 37 weeks or later without evidence of undernutrition at routine health care visits\n* In household with food insecurity at time of screening phone call based on an affirmative response on the 2-item Hunger Vital Signs™ screening tool\n* Primary pediatric care patient at Stanford University\u002FStanford Health Care Network\n* Planned continuation of primary pediatric care at Stanford University\u002FStanford Health Care\n* Living in a community setting (not inpatient or living in a nursing\u002Flong-term care setting) with a caretaker enrolled in this study\n\nExclusion Criteria for Child:\n\n* Gestational age \\\u003C 37 weeks\n* Small-for-gestational age at birth (birth weight for gestational age less than 10th percentile)\n* Weight-for-length \\\u003C 3rd percentile\n* Body Mass Index \\\u003C 5th percentile for age and sex\n* Children in household previously enrolled in this study or the Food FARMacia program\n* Conditions that substantially interfere with growth or mobility (e.g., complex congenital heart disease, cystic fibrosis)\n* Children with special diets (e.g., tyrosinemia, enteral tube feeding)\n* Children with chronic diseases that interfere with nutrition and growth as determined by investigators\n\nInclusion Criteria for Parent\u002FLegal Guardian:\n\n* Primary caretaker of infant eligible for study and with planned enrollment in this study\n* Age 18 years or older\n* Ability to respond to questions in English and\u002For Spanish\n* Willing for self and infant to be randomized into a RCT and complete all study components\n* Gives permission to receive messages to their mobile device, email, and or place of residence\n* Gives permission to complete all study procedures for self and infant\n* Capable of providing informed consent for self and infant\n\nExclusion Criteria for Parent\u002FLegal Guardian:\n\n* Pregnancy at baseline visit because of unique nutritional needs\n* Age \\\u003C 18 years at baseline because of unique developmental differences of adolescents and New York State regulations\n* Inability to complete study visits or intervention components\n* Unwillingness or inability to commit to a 6-month research study for self or infant\n* Unable to give informed consent\n* Underlying disease\u002Ftreatment that might interfere with participation in\u002Fcompletion of the study (e.g., significant gastrointestinal conditions, major psychiatric disorders, and others at the discretion of the study clinician)",[92,93,94],"CHILD","ADULT","OLDER_ADULT",[96,113],{"facility":97,"status":98,"city":99,"state":100,"zip":101,"country":102,"contacts":103,"geoPoint":110},"Stanford University School of Medicine","NOT_YET_RECRUITING","Stanford","California","94305","United States",[104,108],{"name":105,"role":106,"email":107},"Jennifer Woo Baidal, MD","CONTACT","jwoo1@stanford.edu",{"name":105,"role":109},"PRINCIPAL_INVESTIGATOR",{"lat":111,"lon":112},37.42411,-122.16608,{"facility":114,"status":7,"city":115,"state":115,"zip":116,"country":102,"contacts":117,"geoPoint":122},"Columbia University Irving Medical Center","New York","10032",[118,121],{"name":119,"role":106,"email":120},"Ali Mencin, MD","am2363@cumc.columbia.edu",{"name":119,"role":109},{"lat":123,"lon":124},40.71427,-74.00597,[126],{"name":127,"role":106,"phone":128,"email":129},"Study Coordinator","646-369-5048","cropnutrition@stanford.edu",[131],{"name":105,"affiliation":12,"role":109},[],[],{"nct_id":4,"conditions":135,"biomarkers":136},[20,21],[],{"nct_id":4,"found":14,"summary":138,"prompt_version":147},{"design":139,"status":140,"heading":6,"summary":141,"follow_up":142,"word_count":143,"commitments":144,"compensation":145,"drugs_mentioned":146},"This is an interventional study planning to enroll 80 participants. It is designed to test a behavioral intervention.","completed","This study, called Food FARMacia, is looking at whether a program to reduce food insecurity (not having enough food for an active, healthy life) is practical and accepted by families with young infants. The program involves twice-monthly delivery of groceries for up to six months, along with support for healthy meal preparation. All participants will also receive nutrition education. This study is for children aged 6 to less than 18 months who were born at 37 weeks or later, do not show signs of undernutrition, and live in a household experiencing food insecurity. The study aims to enroll 80 participants and is currently unclear on its recruitment status. Success will be measured by how many families join, stay in the study, and receive the food distributions.","The study will track retention for 6 months and recruitment feasibility for 24 months.",126,"Participants will receive twice-monthly grocery deliveries for six months and nutrition education. The study will track attendance at food distributions.","Not stated in the trial record.",[],"v2"]