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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05586269
• Other study ID #: IRB-P00043195
• Status: Completed
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: July 21, 2023

Study information

• Verified date: November 2023
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 21, 2023
• Est. primary completion date: June 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Nutrition Disorders
• Obesity
• Overnutrition
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Dietary Assessment: parent	The PrimeScreen survey will be used to assess dietary changes for the parent (self-reported).	0-4 months
Other	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
Other	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
Primary	Study Feasibility: Recruitment	Number of participants enrolled per month	0-4 months
Primary	Study Feasibility: Randomization	Proportion of eligible screens who enroll	0-4 months
Primary	Study Feasibility: Retention	Proportion of participants who remain in the study at each study visit	0-4 months
Primary	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
Primary	Study Feasibility: Assessments	Proportion of planned assessments completed at each study visit	0-4 months
Secondary	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
Secondary	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
Secondary	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