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Pediatric ObesityNCT05586269

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

A study testing Meal Kit Delivery and Newsletter + Food Pantry Referral in people with Pediatric Obesity and Nutrition Disorders, run by Boston Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 6 years and olderHealthy volunteers can take part
What is being tested?
Meal Kit Delivery and Newsletter + Food Pantry Referral
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteUnited States
Study dates
13 Feb 2023to 25 Jan 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

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.

Read the 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.

Being tested
Meal Kit Delivery, Newsletter + Food Pantry Referral
Keywords
Food Insecurity, Nutrition Security
Medical subject headings
Pediatric Obesity, Nutrition Disorders, Child Nutrition Disorders, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meal Kit DeliveryBehavioural

    Also called EatWell Meal Kits

    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.

  • Newsletter + Food Pantry ReferralBehavioural

    Also called Standard of Care

    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.

Study groups in NCT05586269
Study groupRoleWhat they receive
Meal Kits, Then Newsletter + Food Pantry ReferralExperimentalDyads (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.
Receives: Behavioral: Meal Kit Delivery; Behavioral: Newsletter + Food Pantry Referral
Newsletter + Food Pantry Referral, Then Meal KitsExperimentalDyads (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).
Receives: Behavioral: Meal Kit Delivery; Behavioral: Newsletter + Food Pantry Referral

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Study Feasibility: Recruitment

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

    Measured: 2 months to baseline

  2. Study Feasibility: Randomization

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

    Measured: At baseline

  3. Study Feasibility: Retention

    Number of participants retained at each study visit

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

  4. Study Feasibility: Protocol

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

    Measured: Third study visit (week 14-16)

  5. Study Feasibility: Adherence - Caregivers

    Total number of recipes prepared by caregivers

    Measured: Third study visit (week 14-16)

  6. Study Feasibility: Adherence - Children

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

    Measured: Third study visit (week 14-16)

  7. Study Feasibility: Assessments

    Proportion of planned assessments completed at each study visit

    Measured: 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)

  1. Number of Participants With Household Food Insecurity at the First Study Visit

    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

    Measured: At the baseline first study visit (baseline)

  2. Number of Participants With Household Food Insecurity at Second Study Visit

    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

    Measured: At second study visit (week 6-8)

  3. Number of Participants With Household Food Insecurity at Third Study Visit

    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

    Measured: At third study visit (week 14-16)

  4. Change in BMI For Children With BMI Assessments At All Visits

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

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

  5. Change in BMI Percentage of the 95th Percentile for Children With BMI Assessments at All Visits

    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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2022
  2. Study start13 Feb 2023
  3. Primary completion2 Nov 2023
  4. Study completion25 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05586269
Sponsor's protocol ID
IRB-P00043195
Status last verified
May 2025
First submitted
23 Sep 2022
Last updated
22 May 2025
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual-level data may be shared upon request, under the conditions that an analysis plan is prepared and approved by the PI/Co-Is, Institutional Review Board approval has been obtained, and all necessary data sharing agreements have been executed.

Publications

  • Wu AJ, Huggins M, Lin HG, Caballero-Gonzalez A, Dalvie N, Battista ED, Taveras EM, Fiechtner L. 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. Pediatr Obes. 2024 May;19(5):e13111. doi: 10.1111/ijpo.13111. Epub 2024 Mar 4.

    PubMed 38439559

Questions about this trial

What is this clinical trial studying?

A study testing Meal Kit Delivery and Newsletter + Food Pantry Referral in people with Pediatric Obesity and Nutrition Disorders, run by Boston Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study Feasibility: Recruitment (time frame: 2 months to baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05586269, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.

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