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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05586269
Other study ID # IRB-P00043195
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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