Intervening in Food Insecurity to Reduce and Mitigate (InFoRM) Childhood Obesity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pediatric Obesity
- Sponsor
- Boston Children's Hospital
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Study Feasibility: Recruitment
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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.
Investigators
Allison Wu
Physician, Gastroenterology and Nutrition, Principal Investigator, Instructor of Pediatrics
Boston Children's Hospital
Eligibility Criteria
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
- •The child's primary caregiver will be eligible for enrollment.
Outcomes
Primary Outcomes
Study Feasibility: Recruitment
Time Frame: 2 months to baseline
Proportion of eligible participants who were recruited and enrolled in the intervention, prior to randomization.
Study Feasibility: Randomization
Time Frame: At baseline
Number of participants enrolled per month, then subject to randomization.
Study Feasibility: Retention
Time Frame: 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
Time Frame: Third study visit (week 14-16)
Number of participants who reported receipt of all six weeks of meal kit delivery
Study Feasibility: Adherence - Caregivers
Time Frame: Third study visit (week 14-16)
Total number of recipes prepared by caregivers
Study Feasibility: Adherence - Children
Time Frame: Third study visit (week 14-16)
Number of children who tasted/ate food from the meal kit
Study Feasibility: Assessments
Time Frame: 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 Outcomes
- Number of Participants With Household Food Insecurity at the First Study Visit(At the baseline first study visit (baseline))
- Number of Participants With Household Food Insecurity at Second Study Visit(At second study visit (week 6-8))
- Number of Participants With Household Food Insecurity at Third Study Visit(At third study visit (week 14-16))
- 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))
- 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))