Nutrition, HealthyNCT06051591
Food FARMacia: Reducing Childhood Obesity in Households With Food Insecurity
A study testing Food FARMacia Program and Self-directed meal preparation support in people with Nutrition, Healthy, run by Stanford University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- Food FARMacia Program and Self-directed meal preparation support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2023to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 6 to < 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/Stanford Health Care Network
- Planned continuation of primary pediatric care at Stanford University/Stanford Health Care
- Living in a community setting (not inpatient or living in a nursing/long-term care setting) with a caretaker enrolled in this study
Show all 13Show fewer
- 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/or 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
Who cannot join
- Gestational age < 37 weeks
- Small-for-gestational age at birth (birth weight for gestational age less than 10th percentile)
- Weight-for-length < 3rd percentile
- Body Mass Index < 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)
Show all 14Show fewer
- 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 < 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/treatment that might interfere with participation in/completion of the study (e.g., significant gastrointestinal conditions, major psychiatric disorders, and others at the discretion of the study clinician)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Ali Mencin, MD, am2363@cumc.columbia.edu
Ali Mencin, MD
- Not yet recruiting
Stanford University School of Medicine
Stanford, California, 94305
Jennifer Woo Baidal, MD, jwoo1@stanford.edu
Jennifer Woo Baidal, MD
About this study
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.
Read the detailed description
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.
- Conditions
- Nutrition, Healthy
- Being tested
- Food FARMacia Program, Self-directed meal preparation support
- Keywords
- Childhood Obesity, Food Insecurity
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food FARMacia ProgramBehavioural
Twice monthly delivery of groceries with about 12 meals per household member for up to 4 household members for 6 months.
Self-directed meal preparation supportBehavioural
Nutrition education and anticipatory guidance to support healthy meal preparation
| Study group | Role | What they receive |
|---|---|---|
| Attention Control | Active comparator | Participants will receive nutrition education and anticipatory guidance to support healthy meal preparation in addition to usual care. Receives: Behavioral: Self-directed meal preparation support |
| 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. Receives: Behavioral: Food FARMacia Program; Behavioral: Self-directed meal preparation support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment feasibility
Completion of enrollment of 80 households within the study timeframe
Measured: 24 months
Retention Rate
At least 70% with complete follow-up visits at 6-month follow-up
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start1 Dec 2023
- Primary completion15 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Woo Baidal, Stanford University
- Investigators
- Jennifer Woo Baidal, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051591
- Sponsor's protocol ID
- 76726
- Other IDs
- R01DK134463
- Status last verified
- Mar 2026
- First submitted
- 18 Sep 2023
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant level data
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food FARMacia: Reducing Childhood Obesity in Households With Food Insecurity
- ClinicalTrials.gov ID
- NCT06051591
- Acronym / sponsor ID
- 76726
- Conditions
- Nutrition, Healthy
- Keywords
- Childhood Obesity, Food Insecurity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Attention Control | Active comparator | Behavioral: Self-directed meal preparation supportParticipants will receive nutrition education and anticipatory guidance to support healthy meal preparation in addition to usual care. |
| Food FARMacia intervention | Experimental | Behavioral: Food FARMacia Program, Behavioral: Self-directed meal preparation supportParticipants 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. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Age 6 to < 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/Stanford Health Care Network
- Planned continuation of primary pediatric care at Stanford University/Stanford Health Care
Key exclusion criteria (14 listed)
- Gestational age < 37 weeks
- Small-for-gestational age at birth (birth weight for gestational age less than 10th percentile)
- Weight-for-length < 3rd percentile
- Body Mass Index < 5th percentile for age and sex
- Children in household previously enrolled in this study or the Food FARMacia program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food FARMacia ProgramTwice monthly delivery of groceries with about 12 meals per household member for up to 4 household members for 6 months. | Behavioural | Food FARMacia intervention |
| Self-directed meal preparation supportNutrition education and anticipatory guidance to support healthy meal preparation | Behavioural | Attention Control, Food FARMacia intervention |
Primary outcome
Recruitment feasibility
Time frame: 24 months
Completion of enrollment of 80 households within the study timeframe
Retention Rate
Time frame: 6 months
At least 70% with complete follow-up visits at 6-month follow-up
Attendance Rate (Proportion of food distributions attended/received) - Intervention Arm
Time frame: 6 months
At least 70% median attendance rate for twice monthly food distributions at 6-month follow-up
Intervention Satisfaction - Intervention Arm
Time frame: 6 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified participant level data
Related trials for Nutrition, Healthy
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
Not yet recruitingPhase 1
A Phase I Clinical Trial of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of UBT48128 Tablets in Healthy Participants
Overweight , Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Active, not recruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08653944 in Otherwise Healthy Chinese Adults With Overweight or Obesity
Overweight, Obesity
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Woo Baidal, MD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food FARMacia Program and Self-directed meal preparation support in people with Nutrition, Healthy, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (646-369-5048, cropnutrition@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment feasibility (time frame: 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.