Clinical trial NCT05586269: Intervening in Food Insecurity to Reduce and Mitigate (InFoRM) Childhood Obesity
Official title: Intervening in Food Insecurity to Reduce and Mitigate (InFoRM) Childhood Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Nutrition Disorders
Overnutrition, Child
Obesity
Keywords: Food Insecurity
Nutrition Security
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 59
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Dyads (caregiver + child) will be randomized to one of two intervention sequences:

1. Meal kit intervention without delay followed by newsletter + pantry referral
2. Newsletter + pantry referral followed by meal kit intervention
Primary purpose: TREATMENT

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.

Eligibility criteria: Child 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.

Primary outcomes:
measure: Study Feasibility: Recruitment
timeFrame: 2 months to baseline
measure: Study Feasibility: Randomization
timeFrame: At baseline
measure: Study Feasibility: Retention
timeFrame: At the baseline first study visit (baseline), at the second study visit (week 6-8), and at the third study visit (week 14-16).
measure: Study Feasibility: Protocol
timeFrame: Third study visit (week 14-16)
measure: Study Feasibility: Adherence - Caregivers
timeFrame: Third study visit (week 14-16)
measure: Study Feasibility: Adherence - Children
timeFrame: Third study visit (week 14-16)
measure: Study Feasibility: Assessments
timeFrame: At the baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)
Secondary outcomes:
measure: Number of Participants With Household Food Insecurity at the First Study Visit
timeFrame: At the baseline first study visit (baseline)
measure: Number of Participants With Household Food Insecurity at Second Study Visit
timeFrame: At second study visit (week 6-8)
measure: Number of Participants With Household Food Insecurity at Third Study Visit
timeFrame: At third study visit (week 14-16)
measure: Change in BMI For Children With BMI Assessments At All Visits
timeFrame: At baseline, at second study visit (week 6-8), and at third study visit (week 14-16)
measure: Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits
timeFrame: At baseline, at second study visit (week 6-8), and at third study visit (week 14-16)
Other outcomes:
measure: Total Prime Diet Quality Score at Each Study Visit: Children
timeFrame: At baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)
measure: Total Prime Diet Quality Score at Each Study Visit: Caregiver
timeFrame: At baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)
measure: Caregiver Reported Mealtime Behavior at First Study Visit
timeFrame: At baseline first study visit (baseline)
measure: Caregiver Reported Mealtime Behavior at Second Study Visit
timeFrame: At second study visit (week 6-8)
measure: Caregiver Reported Mealtime Behavior at Third Study Visit
timeFrame: At third study visit (week 14-16)
measure: Caregiver Perceived Stress at First Study Visit
timeFrame: At baseline first study visit (baseline)
measure: Caregiver Perceived Stress at Second Study Visit
timeFrame: At second study visit (week 6-8)
measure: Caregiver Perceived Stress at Third Study Visit
timeFrame: At third study visit (week 14-16)
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Allison J Wu, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: