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

Not Applicable

Completed

Conditions: Nutrition Disorders
Overnutrition, Child
Obesity
Pediatric Obesity

Interventions: Behavioral: Meal Kit Delivery

Registration Number: NCT05586269

Lead Sponsor: Boston Children's Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 59

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Meal Kits	Meal Kit Delivery	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.
Delayed Meal Kits	Meal Kit Delivery	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Household Food Insecurity at the First Study Visit	At the baseline first study visit (baseline)	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
Number of Participants With Household Food Insecurity at Second Study Visit	At second study visit (week 6-8)	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
Number of Participants With Household Food Insecurity at Third Study Visit	At third study visit (week 14-16)	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
Change in BMI For Children With BMI Assessments At All Visits	At baseline, at second study visit (week 6-8), and at third study visit (week 14-16)	Weight and height were combined to report BMI in kg/m\^2 based on Centers for Disease Control growth curves.
Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits	At baseline, at second study visit (week 6-8), and at third study visit (week 14-16)	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