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

NCT05586269 | Completed Results

• 1 other identifier: IRB-P00043195
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity; Nutrition Disorders; Overnutrition, Child; Obesity

Keywords

Food Insecurity; Nutrition Security

Outcome Measures

Primary Outcomes (7)

• Study Feasibility: Recruitment

  Proportion of eligible participants who were recruited and enrolled in the intervention, prior to randomization.

  2 months to baseline

• Study Feasibility: Randomization

  Number of participants enrolled per month, then subject to randomization.

  At baseline

• Study Feasibility: Retention

  Number of participants retained at each study visit

  At the baseline first study visit (baseline), at the second study visit (week 6-8), and at the third study visit (week 14-16).

• Study Feasibility: Protocol

  Number of participants who reported receipt of all six weeks of meal kit delivery

  Third study visit (week 14-16)

• Study Feasibility: Adherence - Caregivers

  Total number of recipes prepared by caregivers

  Third study visit (week 14-16)

• Study Feasibility: Adherence - Children

  Number of children who tasted/ate food from the meal kit

  Third study visit (week 14-16)

• Study Feasibility: Assessments

  Proportion of planned assessments completed at each study visit

  At the baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)

Secondary Outcomes (5)

• 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)

Other Outcomes (8)

• Total Prime Diet Quality Score at Each Study Visit: Children

  At baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)

• Total Prime Diet Quality Score at Each Study Visit: Caregiver

  At baseline first study visit (baseline), at second study visit (week 6-8), and at third study visit (week 14-16)

• Caregiver Reported Mealtime Behavior at First Study Visit

  At baseline first study visit (baseline)

Study Arms (2)

Meal Kits, Then Newsletter + Food Pantry Referral

EXPERIMENTAL

Dyads (caregiver + child) receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration). After the second study visit, they receive a newsletter and food pantry referral.

Behavioral: Meal Kit Delivery; Behavioral: Newsletter + Food Pantry Referral

Newsletter + Food Pantry Referral, Then Meal Kits

EXPERIMENTAL

Dyads (caregiver + child) receive a newsletter and food pantry referral. After the second study visit, they receive weekly healthy meal kits with fresh ingredients and simple recipes (6 weeks duration).

Behavioral: Meal Kit Delivery; Behavioral: Newsletter + Food Pantry Referral

Interventions

Meal Kit Delivery BEHAVIORAL

Dyads (caregiver + child) receive one meal kit delivery per week. One meal kit is designed to include two recipes and ingredients to prepare 10 servings (\~2 meals for a household 5 people). Meal kits come with printed picture-based recipes in English or Spanish and access to online cooking demonstrations.

Also known as: EatWell Meal Kits

Meal Kits, Then Newsletter + Food Pantry Referral; Newsletter + Food Pantry Referral, Then Meal Kits

Newsletter + Food Pantry Referral BEHAVIORAL

Dyads (caregiver + child) receive a printed newsletter in English and Spanish that lists additional local food assistance resources. Dyads receive a referral to the clinic's associated food pantry.

Also known as: Standard of Care

Meal Kits, Then Newsletter + Food Pantry Referral; Newsletter + Food Pantry Referral, Then Meal Kits

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Nutrition Disorders; Child Nutrition Disorders; Obesity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Consistent with the goal of the pilot phase I study, the analysis is descriptive. This phase I study was not intended to be powered to detect changes in the secondary outcomes. Secondary outcomes were collected to determine the feasibility of the assessments.

Results Point of Contact

• Title: Dr. Allison Wu
• Organization: Boston Children's Hospital

allison.wu@childrens.harvard.edu

6173556058

Study Officials

• Allison J Wu, MD, MPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Gastroenterology and Nutrition, Principal Investigator, Instructor of Pediatrics

Model Details: 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

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: October 19, 2022
• Study Start: February 13, 2023
• Primary Completion: November 2, 2023
• Study Completion: January 25, 2024
• Last Updated: May 22, 2025
• Results First Posted: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data can be requested by emailing the PI.
• Access Criteria: 1. An analysis plan is prepared and approved by the PI/Co-Is, 2. IRB approval has been obtained, and 3. All necessary data sharing agreements have been executed.

Locations

US (1)