Health TrialsbyHealthPanel

Food FARMacia: Reducing Childhood Obesity in Households With Food Insecurity

ConditionNutrition, Healthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Self-directed meal preparation support

    Behavioral

    Nutrition education and anticipatory guidance to support healthy meal preparation

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Attention ControlActive comparator 1 intervention
Group B: Food FARMacia interventionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Recruitment feasibility

Completion of enrollment of 80 households within the study timeframe

Time frame
24 months
2

Retention Rate

At least 70% with complete follow-up visits at 6-month follow-up

Time frame
6 months
3

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

Time frame
6 months
4

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

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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