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

NCT ID: NCT05586269

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-13
• Study Completion Date: 2024-01-25

Brief 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.

Detailed 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.

Conditions

Pediatric Obesity; Nutrition Disorders; Overnutrition, Child; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Meal Kits, Then Newsletter + Food Pantry Referral

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.

Group Type: EXPERIMENTAL

Meal Kit Delivery

Intervention Type: BEHAVIORAL

Dyads (caregiver + child) receive one meal kit delivery per week. One meal kit is designed to include two recipes and ingredients to prepare 10 servings (\~2 meals for a household 5 people). Meal kits come with printed picture-based recipes in English or Spanish and access to online cooking demonstrations.

Newsletter + Food Pantry Referral

Intervention Type: BEHAVIORAL

Dyads (caregiver + child) receive a printed newsletter in English and Spanish that lists additional local food assistance resources. Dyads receive a referral to the clinic's associated food pantry.

Newsletter + Food Pantry Referral, Then Meal Kits

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).

Group Type: EXPERIMENTAL

Meal Kit Delivery

Intervention Type: BEHAVIORAL

Dyads (caregiver + child) receive one meal kit delivery per week. One meal kit is designed to include two recipes and ingredients to prepare 10 servings (\~2 meals for a household 5 people). Meal kits come with printed picture-based recipes in English or Spanish and access to online cooking demonstrations.

Newsletter + Food Pantry Referral

Intervention Type: BEHAVIORAL

Dyads (caregiver + child) receive a printed newsletter in English and Spanish that lists additional local food assistance resources. Dyads receive a referral to the clinic's associated food pantry.

Interventions

Meal Kit Delivery

Dyads (caregiver + child) receive one meal kit delivery per week. One meal kit is designed to include two recipes and ingredients to prepare 10 servings (\~2 meals for a household 5 people). Meal kits come with printed picture-based recipes in English or Spanish and access to online cooking demonstrations.

Intervention Type: BEHAVIORAL

Newsletter + Food Pantry Referral

Dyads (caregiver + child) receive a printed newsletter in English and Spanish that lists additional local food assistance resources. Dyads receive a referral to the clinic's associated food pantry.

Intervention Type: BEHAVIORAL

Other Intervention Names

EatWell Meal Kits; Standard of Care

Eligibility Criteria

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

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.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Allison Wu

Physician, Gastroenterology and Nutrition, Principal Investigator, Instructor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allison J Wu, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB-P00043195

Identifier Type: -

Identifier Source: org_study_id