Food InsecurityNCT05640414
Weekly Family Food Packages: Food is Medicine
A study testing Weekly Family Food Packages and Family Health Group Sessions in people with Food Insecurity and Overweight, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The specific aims and objectives of this proposal are to: 1. Evaluate a food pantry's weekly food distribution impact on behavioral, social and health outcomes in families. 2. In a subset of families with a child aged 6-17 years, test a pilot intervention offering the following components, with a goal of improving… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Food Insecurity, Overweight, Obesity
- What is being tested?
- Weekly Family Food Packages and Family Health Group Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 3 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Referral to the food pantry
- Additional inclusion criteria for Group Sessions:
- Family has a child aged 6-17 years
Who cannot join
- Not able to speak English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH Revere HealthCare Center
Revere, Massachusetts, 02151
About this study
Official title: Healthy Families Clinic and Teaching Kitchen Program
The specific aims and objectives of this proposal are to:
- Evaluate a food pantry's weekly food distribution impact on behavioral, social and health outcomes in families.
- In a subset of families with a child aged 6-17 years, test a pilot intervention offering the following components, with a goal of improving family behavioral, social and health outcomes:
- Weekly family food packages from the Revere Food Pantry
- 6-Monthly group sessions that include information on healthy behaviors, chronic disease management and teaching families how to prepare simple recipes based on the food they receive that week from the food pantry.
- Conditions
- Food Insecurity, Overweight, Obesity, Cardiometabolic Syndrome
- Being tested
- Weekly Family Food Packages, Family Health Group Sessions
- Medical subject headings
- Overweight, Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly Family Food PackagesOther
Families receive weekly family food packages for 6 months
Family Health Group SessionsBehavioural
Families with children aged 6-17 years attend 6 monthly group sessions with cooking demonstrations
| Study group | Role | What they receive |
|---|---|---|
| Weekly Family Food Packages | Experimental | Not described Receives: Other: Weekly Family Food Packages |
| Family Health Group Sessions | Experimental | Not described Receives: Other: Weekly Family Food Packages; Behavioral: Family Health Group Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI at 6 months
Weight in kg and height in meters will be combined to report BMI in kg/m^2, as reported in the electronic health record
Measured: 0-6 months
Change in Food Insecurity Status at 3 months
Food insecurity status assessed by the Hunger Vital Signs questionnaire
Measured: 0-3 months
Change in Diet Quality at 3 months
Diet quality assessed by an abbreviated food frequency questionnaire
Measured: 0-3 months
Secondary outcomes (5)
Change in Binge Eating Symptoms at 3 months
Binge eating symptoms assessed by questionnaire
Measured: 0-3 months
Change in Blood Pressure at 6 months
Blood pressure as reported in the electronic health record
Measured: 0-6 months
Change in Sleep at 3 months
Sleep duration as reported by questionnaire
Measured: 0-3 months
Change in Physical Activity at 3 months
Physical activity as reported by questionnaire
Measured: 0-3 months
Change in Screen Time at 3 months
Screen time as reported by questionnaire
Measured: 0-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start1 Feb 2023
- Primary completion3 Mar 2025
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Pediatrics, Ardmore Foundation, Vitamix Foundation
- Responsible party
- Principal investigator, Lauren G. Fiechtner, M.D., Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640414
- Sponsor's protocol ID
- 2022P002892
- Status last verified
- Apr 2025
- First submitted
- 23 Nov 2022
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- 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, IRB approval has been obtained, and all necessary data sharing agreements have been executed.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Families Clinic and Teaching Kitchen Program
- ClinicalTrials.gov ID
- NCT05640414
- Acronym / sponsor ID
- 2022P002892
- Conditions
- Food Insecurity, Overweight, Obesity, Cardiometabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American Academy of Pediatrics, Ardmore Foundation, Vitamix Foundation
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aims and objectives of this proposal are to:
- Evaluate a food pantry's weekly food distribution impact on behavioral, social and health outcomes in families.
- In a subset of families with a child aged 6-17 years, test a pilot intervention offering the following components, with a goal of improving family behavioral, social and health outcomes:
- Weekly family food packages from the Revere Food Pantry
- 6-Monthly group sessions that include information on healthy behaviors, chronic disease management and teaching families how to prepare simple recipes based on the food they receive that week from the food pantry.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weekly Family Food Packages | Experimental | Other: Weekly Family Food Packages |
| Family Health Group Sessions | Experimental | Other: Weekly Family Food Packages, Behavioral: Family Health Group Sessions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Referral to the food pantry
- Family has a child aged 6-17 years
Key exclusion criteria (1 listed)
- Not able to speak English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weekly Family Food PackagesFamilies receive weekly family food packages for 6 months | Other | Family Health Group Sessions, Weekly Family Food Packages |
| Family Health Group SessionsFamilies with children aged 6-17 years attend 6 monthly group sessions with cooking demonstrations | Behavioural | Family Health Group Sessions |
Primary outcome
Change in BMI at 6 months
Time frame: 0-6 months
Weight in kg and height in meters will be combined to report BMI in kg/m^2, as reported in the electronic health record
Change in Food Insecurity Status at 3 months
Time frame: 0-3 months
Food insecurity status assessed by the Hunger Vital Signs questionnaire
Change in Diet Quality at 3 months
Time frame: 0-3 months
Diet quality assessed by an abbreviated food frequency questionnaire
5 secondary outcomes
Change in Binge Eating Symptoms at 3 months
Time frame: 0-3 months
Change in Blood Pressure at 6 months
Time frame: 0-6 months
Change in Sleep at 3 months
Time frame: 0-3 months
Change in Physical Activity at 3 months
Time frame: 0-3 months
Change in Screen Time at 3 months
Time frame: 0-3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: 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, IRB approval has been obtained, and all necessary data sharing agreements have been executed.
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Recruiting
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Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
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Addressing Food Insecurity in Pregnancy
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Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly Family Food Packages and Family Health Group Sessions in people with Food Insecurity and Overweight, run by Massachusetts General 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?
The sponsor lists 3 inclusion and 1 exclusion criteria. 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 15 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in BMI at 6 months (time frame: 0-6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2025.