N/A
N=59
Intervening in Food Insecurity to Reduce and Mitigate (InFoRM) Childhood Obesity
Pediatric Obesity · Nutrition Disorders · Overnutrition, Child · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT05586269 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Study Feasibility: Recruitment — 59; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Meal Kit Delivery (Behavioral); Newsletter + Food Pantry Referral (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Boston Children's Hospital
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Study Feasibility: Recruitment |
59; 10 | — |
| PRIMARY Study Feasibility: Randomization |
20; 20; 9; 10 | — |
| PRIMARY Study Feasibility: Retention |
13; 14; 15; 15; 1; 1 | — |
| PRIMARY Study Feasibility: Protocol |
19; 22 | — |
| PRIMARY Study Feasibility: Adherence - Caregivers |
3; 2; 4; 4; 2; 5 | — |
| PRIMARY Study Feasibility: Adherence - Children |
10; 11 | — |
| PRIMARY Study Feasibility: Assessments |
56; 60; 32; 35; 38; 43 | — |
| SECONDARY Number of Participants With Household Food Insecurity at the First Study Visit |
0; 0; 1; 0; 8; 11 | — |
| SECONDARY Number of Participants With Household Food Insecurity at Second Study Visit |
1; 1; 1; 1; 5; 8 | — |
| SECONDARY Number of Participants With Household Food Insecurity at Third Study Visit |
2; 2; 0; 1; 5; 7 | — |
| SECONDARY Change in BMI For Children With BMI Assessments At All Visits |
26.29; 24.82; 26.64; 24.67; 26.54; 24.66 | — |
| SECONDARY Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits |
117.5; 113.3; 118.5; 111.8; 117.3; 111.0 | — |
Summary
The goals of this study are to 1) pilot the feasibility of a novel meal kit delivery intervention in families and children with food insecurity and obesity and 2) evaluate the implementation of the pilot intervention.
Eligibility Criteria
Child Inclusion Criteria:
- Children >=6 years and =95th percentile
- Children who screen positive on the 2-item Hunger Vital Sign™
- Children living in a household of <=5 people
- Children living with an English and/or Spanish-speaking caregiver
- Children living within the EatWell delivery map boundaries in the greater Boston area
Child Exclusion Criteria:
- History of food allergies or intolerance to dairy, gluten, soy, or any potential component of the meal kit
- History of malabsorptive intestinal disease (e.g., Crohn's disease, celiac disease)
- History of type 1 or 2 diabetes
- History of solid tumor or bone marrow transplant
- Enteral tube dependence
The child's primary caregiver will be eligible for enrollment.
Data sourced from ClinicalTrials.gov (NCT05586269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.