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.

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.

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

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.

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).

Families receive 6 weeks of healthy meal kit delivery. Meal kits come with embedded nutrition education and access to online cooking demonstrations.

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

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

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.

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.

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

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

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.

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.