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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Nutrition Disorders; Pediatric Obesity; Overnutrition, Child
• Intervention / Treatment: Behavioral: Meal Kit Delivery; Behavioral: Newsletter + Food Pantry Referral

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Other Names: EatWell Meal Kits; 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.; Other Names: Standard of Care
Experimental: 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).	Behavioral: 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.; Other Names: EatWell Meal Kits; 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.; Other Names: Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Feasibility: Recruitment	Proportion of eligible participants who were recruited and enrolled in the intervention, prior to randomization.	2 months to baseline
Study Feasibility: Randomization	Number of participants enrolled per month, then subject to randomization.	At baseline
Study Feasibility: Retention	Number of participants retained at each study visit	At the baseline first study visit (baseline), at the second study visit (week 6-8), and at the third study visit (week 14-16).
Study Feasibility: Protocol	Number of participants who reported receipt of all six weeks of meal kit delivery	Third study visit (week 14-16)
Study Feasibility: Adherence - Caregivers	Total number of recipes prepared by caregivers	Third study visit (week 14-16)
Study Feasibility: Adherence - Children	Number of children who tasted/ate food from the meal kit	Third study visit (week 14-16)
Study Feasibility: Assessments	Proportion of planned assessments completed at each study visit	At the baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Household Food Insecurity at the First Study Visit	Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into: Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security	At the baseline first study visit (baseline)
Number of Participants With Household Food Insecurity at Second Study Visit	Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into: Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security	At second study visit (week 6-8)
Number of Participants With Household Food Insecurity at Third Study Visit	Severity of food insecurity was assessed using the US Household Food Security Survey Module, which is categorized by the raw score into: Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security	At third study visit (week 14-16)
Change in BMI For Children With BMI Assessments At All Visits	Weight and height were combined to report BMI in kg/m^2 based on Centers for Disease Control growth curves.	At baseline, at second study visit (week 6-8), and at third study visit (week 14-16)
Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits	BMI percentage of the 95th percentile (BMIp95) was calculated using CDC extended BMI-for-age growth charts for children with BMI assessments at all study visits	At baseline, at second study visit (week 6-8), and at third study visit (week 14-16)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Prime Diet Quality Score at Each Study Visit: Children	The PrimeScreen survey was used to assess the total prime diet quality score (PDQS) for the child (parent-reported). The survey enables calculation of a food group's daily intake frequency. Scores range from 5 (minimum) to 65 (maximum) across thirteen food groups. A higher score indicates more healthy diet quality.	At baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)
Total Prime Diet Quality Score at Each Study Visit: Caregiver	The PrimeScreen survey was used to assess the total prime diet quality score (PDQS) for the caregiver (self-reported). The survey enables calculation of a food group's daily intake frequency. Scores range from 5 (minimum) to 65 (maximum) across thirteen food groups. A higher score indicates more healthy diet quality.	At baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)
Caregiver Reported Mealtime Behavior at First Study Visit	Caregivers rated Likert scale items from 1 (never) to 5 (everyday): "How often does your child eat dinner together with family members?"	At baseline first study visit (baseline)
Caregiver Reported Mealtime Behavior at Second Study Visit	Caregivers rated Likert scale items from 1 (never) to 5 (everyday): "How often does your child eat dinner together with family members?"	At second study visit (week 6-8)
Caregiver Reported Mealtime Behavior at Third Study Visit	Caregivers rated Likert scale items from 1 (never) to 5 (everyday): "How often does your child eat dinner together with family members?"	At third study visit (week 14-16)
Caregiver Perceived Stress at First Study Visit	The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress: 0-13: low stress 14-26: moderate stress 27-40: high perceived stress	At baseline first study visit (baseline)
Caregiver Perceived Stress at Second Study Visit	The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress: 0-13: low stress 14-26: moderate stress 27-40: high perceived stress	At second study visit (week 6-8)
Caregiver Perceived Stress at Third Study Visit	The Perceived Stress Scale was used to assess changes in stress (caregiver self-reported). Scores range from 0 to 40 with higher scores indicating higher perceived stress: 0-13: low stress 14-26: moderate stress 27-40: high perceived stress	At third study visit (week 14-16)

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Allison J Wu, MD, MPH, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Actual): November 2, 2023
• Study Completion (Actual): January 25, 2024

Study Registration Dates

• First Submitted: September 23, 2022
• First Submitted That Met QC Criteria: October 17, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Food Insecurity; Nutrition Security
• Additional Relevant MeSH Terms: Body Weight; Overweight; Obesity; Pediatric Obesity; Nutrition Disorders; Child Nutrition Disorders; Overnutrition
• Other Study ID Numbers: IRB-P00043195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual-level data may be shared upon request, under the conditions that an analysis plan is prepared and approved by the PI/Co-Is, Institutional Review Board approval has been obtained, and all necessary data sharing agreements have been executed.
• IPD Sharing Time Frame: Data can be requested by emailing the PI.
• IPD Sharing Access Criteria: An analysis plan is prepared and approved by the PI/Co-Is,; IRB approval has been obtained, and; All necessary data sharing agreements have been executed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No