NCT05586269 is a NA clinical trial of Meal Kit Delivery in Pediatric Obesity, sponsored by Boston Children's Hospital.

Who is sponsoring NCT05586269?

NCT05586269 is sponsored by Boston Children's Hospital.

What drugs are being tested in NCT05586269?

Interventions in NCT05586269: Meal Kit Delivery, Newsletter + Food Pantry Referral.

What condition does NCT05586269 study?

NCT05586269 studies Pediatric Obesity, Nutrition Disorders, Overnutrition, Child, Obesity.

Is NCT05586269 still recruiting?

NCT05586269 is currently completed. Last updated 22 May 2025.

Are results published for NCT05586269?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-05-22 · How we verify

NCT05586269

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Results posted Last updated 22 May 2025

What this trial tests

NA trial testing Meal Kit Delivery in Pediatric Obesity in 59 participants. Completed in 25 January 2024.

Timeline

13 February 2023

Primary endpoint
2 November 2023

25 January 2024

Quick facts

Lead sponsor	Boston Children's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	59
Start date	13 February 2023
Primary completion	2 November 2023
Estimated completion	25 January 2024
Sites	1 location across United States

Drugs / interventions tested

Meal Kit Delivery
Newsletter + Food Pantry Referral

Conditions studied

Pediatric Obesity — all drugs for Pediatric Obesity →
Nutrition Disorders — all drugs for Nutrition Disorders →
Overnutrition, Child — all drugs for Overnutrition, Child →
Obesity — all drugs for Obesity →

Sponsor

Boston Children's Hospital

Who can join

6 and older, any sex, with Pediatric Obesity or Nutrition Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Study Feasibility: Recruitment Primary · 2 months to baseline

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

Group	Value	95% CI
Both Arms	59
Both Arms	10

Study Feasibility: Randomization Primary · At baseline

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

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	20
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	20
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	9
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	10

Study Feasibility: Retention Primary · 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

First study visit

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral: Caregiver	13
Meal Kit Delivery, Then Newsletter + Food Pantry Referral: Children	14
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver	15
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children	15
Meal Kit Delivery, Then Newsletter + Food Pantry Referral: Caregiver	1
Meal Kit Delivery, Then Newsletter + Food Pantry Referral: Children	1
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver	0
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children	0

Second study visit

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral: Caregiver	10
Meal Kit Delivery, Then Newsletter + Food Pantry Referral: Children	11
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver	12
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children	12
Meal Kit Delivery, Then Newsletter + Food Pantry Referral: Caregiver	3
Meal Kit Delivery, Then Newsletter + Food Pantry Referral: Children	3
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver	3
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children	3

Third study visit

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral: Caregiver	10
Meal Kit Delivery, Then Newsletter + Food Pantry Referral: Children	11
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver	11
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children	11
Meal Kit Delivery, Then Newsletter + Food Pantry Referral: Caregiver	0
Meal Kit Delivery, Then Newsletter + Food Pantry Referral: Children	0
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregiver	1
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Children	1

Study Feasibility: Protocol Primary · Third study visit (week 14-16)

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

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	19
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	22

Study Feasibility: Adherence - Caregivers Primary · Third study visit (week 14-16)

Total number of recipes prepared by caregivers

Caregivers who prepared 7-12 recipes

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	3
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	2

Caregivers who prepared 3-6 recipes

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	4
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	4

Caregivers who prepared 1-2 recipes

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	2
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	5

Caregivers who did not prepare any recipe

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	1
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	0

Study Feasibility: Adherence - Children Primary · Third study visit (week 14-16)

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

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	10
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	11

Study Feasibility: Assessments Primary · 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

Planned assessments completed after visit 1

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	56
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	60

Planned assessments completed after visit 2

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	32
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	35

Planned assessments completed after visit 3

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	38
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	43

Number of Participants With Household Food Insecurity at the First Study Visit Secondary · At the baseline first study visit (baseline)

Severity of food insecurity was 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

High food security

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	0
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	0

Marginal food security

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	1
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	0

Low food security

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	8
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	11

Very low food security

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	4
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	4

Number of Participants With Household Food Insecurity at Second Study Visit Secondary · At second study visit (week 6-8)

High

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	1
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	1

Marginal food security

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	1
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	1

Low food security

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	5
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	8

Very low food security

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	3
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	2

Number of Participants With Household Food Insecurity at Third Study Visit Secondary · At third study visit (week 14-16)

High food security

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	2
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	2

Marginal food security

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	0
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	1

Low food security

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	5
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	7

Very low food security

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	2
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	1

Change in BMI For Children With BMI Assessments At All Visits Secondary · At baseline, at second study visit (week 6-8), and at third study visit (week 14-16)

Weight and height were combined to report BMI in kg/m\^2 based on Centers for Disease Control growth curves.

BMI at Baseline

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral: Caregivers	26.29	± 3.07
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregivers	24.82	± 2.85

BMI at Visit 2

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral: Caregivers	26.64	± 2.78
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregivers	24.67	± 2.68

BMI at Visit 3

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral: Caregivers	26.54	± 2.81
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregivers	24.66	± 2.81

Change from Baseline at Visit 2

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral: Caregivers	0.36	± 1.52
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregivers	-0.15	± 0.59

Change from Baseline at Visit 3

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral: Caregivers	0.26	± 1.77
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregivers	-0.16	± 0.50

Change from Visit 2 and Visit 3

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral: Caregivers	-0.10	± 0.62
Newsletter + Food Pantry Referral, Then Meal Kit Delivery: Caregivers	-0.01	± 0.70

Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits Secondary · At baseline, at second study visit (week 6-8), and at third study visit (week 14-16)

BMI percentage of the 95th percentile (BMIp95) was calculated using CDC extended BMI-for-age growth charts for children with BMI assessments at all study visits

BMIp95 at Baseline

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	117.5	± 12
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	113.3	± 11

BMIp95 at Visit 2

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	118.5	± 12
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	111.8	± 12

BMIp95 at Visit 3

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	117.3	± 12
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	111.0	± 12

Change from Baseline at Visit 2

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	1.0	± 7
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	-1.5	± 2

Change from Baseline at Visit 3

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	-0.2	± 8
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	-2.3	± 2

Change from Visit 2 to Visit 3

Group	Value	95% CI
Meal Kit Delivery, Then Newsletter + Food Pantry Referral	-1.1	± 3
Newsletter + Food Pantry Referral, Then Meal Kit Delivery	-0.8	± 3

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Satisfaction with a meal kit delivery program and feasibility of a phase I trial in the intervening in food insecurity to reduce and mitigate (InFoRM) childhood obesity study.
Wu AJ, Huggins M, Lin HG, Caballero-Gonzalez A, et al · · 2024 · cited 2× · PMID 38439559 · DOI 10.1111/ijpo.13111
Caregiver and Pediatrician Perspectives on a Meal Kit Delivery Program for Children With Food Insecurity and Obesity: A Qualitative Analysis.
Chapman KL, Caballero-Gonzalez AM, Fiechtner L, Taveras EM, et al · · 2025 · PMID 40188948 · DOI 10.1016/j.jand.2025.04.001

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05586269 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boston Children's Hospital
Last refreshed: 22 May 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05586269.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT05586269

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Pediatric Obesity

Other Boston Children's Hospital trials

Verify against primary sources