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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: Meal Kit Delivery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Families will be randomized to one of two intervention sequences: Meal kit intervention without delay followed by newsletter + pantry referral Newsletter + pantry referral followed by meal kit intervention after a delay of 8 weeks
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meal Kits<br>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<br>* Families receive 6 weeks of healthy meal kit delivery. Meal kits come with embedded nutrition education and access to online cooking demonstrations.<br>* Other names: EatWell Meal Kits;|
| Experimental: Delayed Meal Kits<br>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<br>* Families receive 6 weeks of healthy meal kit delivery. Meal kits come with embedded nutrition education and access to online cooking demonstrations.<br>* Other names: EatWell Meal Kits;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food Insecurity, Nutrition Security