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

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): 30
• 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)
• Accepts Healthy Volunteers: Yes

Description

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

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; Families receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration), followed by a washout period of 2 weeks, and then receive a newsletter and food pantry referral.	Behavioral: Meal Kit Delivery; Families receive 6 weeks of healthy meal kit delivery. Meal kits come with embedded nutrition education and access to online cooking demonstrations.; Other Names: EatWell Meal Kits
Experimental: Delayed Meal Kits; Families receive a newsletter and food pantry referral. After 8 weeks, families will receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).	Behavioral: Meal Kit Delivery; Families receive 6 weeks of healthy meal kit delivery. Meal kits come with embedded nutrition education and access to online cooking demonstrations.; Other Names: EatWell Meal Kits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Feasibility: Recruitment	Number of participants enrolled per month	0-4 months
Study Feasibility: Randomization	Proportion of eligible screens who enroll	0-4 months
Study Feasibility: Retention	Proportion of participants who remain in the study at each study visit	0-4 months
Study Feasibility: Protocol/Adherence	Treatment-specific fidelity rates, including proportion of meal kits delivered, proportion of meal kits received, proportion of meal kits prepared, and proportion of meal kits consumed	0-4 months
Study Feasibility: Assessments	Proportion of planned assessments completed at each study visit	0-4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Household Food Insecurity	Severity of food insecurity will be 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	0-4 months
Change in Child BMI	Weight and height will be combined to report BMI in kg/m^2 based on CDC growth curves.	0-4 months
Change in Child BMI percent of the 95th percentile	Weight and height will be combined to report BMI in kg/m^2 based on CDC growth curves.	0-4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary Assessment: child	The PrimeScreen survey will be used to assess dietary changes for the child (parent-reported). The survey enables calculation of a food group's daily intake frequency.	0-4 months
Dietary Assessment: parent	The PrimeScreen survey will be used to assess dietary changes for the parent (self-reported).	0-4 months
Mealtime Behaviors	Parents will rate Likert scale items from 1 (never) to 5 (everyday) about the frequency of mealtime behaviors and interactions with their child. We will compare these frequencies at baseline, mid-study and completion of study.	0-4 months
Perceived Stress	The Perceived Stress Scale will be used to assess changes in stress (parent 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	0-4 months

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): June 21, 2023
• Study Completion (Actual): July 21, 2023

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): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Food Insecurity; Nutrition Security
• Additional Relevant MeSH Terms: Overweight; Body Weight; 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, IRB 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