Intervening in Food Insecurity to Reduce and Mitigate (InFoRM) Childhood Obesity

Boston Children's Hospital

Status: Completed

Conditions: Nutrition Disorders; Obesity; Overnutrition, Child; Pediatric Obesity

Treatments: Behavioral: Meal Kit Delivery; Behavioral: Newsletter + Food Pantry Referral

Study type: Interventional

Funder types: Other

Identifiers

NCT05586269

IRB-P00043195

Details and patient eligibility

About

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.

Full description

Childhood obesity prevalence is rising in the U.S. and is known to track into adulthood, increasing the risks of chronic diseases such as type 2 diabetes. Households of children with obesity also face unmet social needs, such as food insecurity. Food insecurity is associated with poorer dietary quality and higher prevalence of obesity and diabetes in adults; however, data are inconsistent and less known regarding longitudinal health effects in children. Because food insecurity and childhood obesity tend to co-occur in Black, Hispanic, and lower-income households, there is an urgent need to examine and intervene in the social determinants associated with rising childhood obesity prevalence.

Enrollment: 59 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Child Inclusion Criteria:

• Children >=6 years and <12 years old with a BMI >=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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

Meal Kits, Then Newsletter + Food Pantry Referral

Experimental group

Description:

Dyads (caregiver + child) receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.

Treatment:

Behavioral: Newsletter + Food Pantry Referral

Behavioral: Meal Kit Delivery

Newsletter + Food Pantry Referral, Then Meal Kits

Experimental group

Description:

Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).

Treatment:

Behavioral: Newsletter + Food Pantry Referral

Behavioral: Meal Kit Delivery