Food InsecurityFAVOResNCT07149350
Food Access, Value, and Optimization of Resources
A study testing FAVORes Workshop in people with Food Insecurity and Health Behavior, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The main goal of the study is to examine the potential benefits of an educational workshop designed to help and support caregivers of children in families that struggle to get enough healthy food. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity, Health Behavior, Nutrition
- What is being tested?
- FAVORes Workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Proficient in English or Spanish
- Attendance at the 1-hour "Towards Food Equity" Zoom session led by MEHC Social Work
Who cannot join
- Inability or anticipated inability to attend scheduled in-person workshop sessions for the duration of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Martha Eliot Health Center
Jamaica Plain, Massachusetts, 02130
About this study
The main goal of the study is to examine the potential benefits of an educational workshop designed to help and support caregivers of children in families that struggle to get enough healthy food. The main questions are:
- Does the FAVORes workshop impact household food and nutrition security?
- Does the workshop change caregivers' knowledge, beliefs, and skills related to healthy food access?
Participants will:
- Attend four weekly in-person sessions (in English or Spanish)
- Complete short surveys
- Be interviewed after the workshop is completed (optional)
Read the detailed description
The FAVORes (Food Access, Value, and Optimization of Resources) study at Boston Children's Martha Eliot Health Center (MEHC) aims to help families struggling with healthy food access. Over one in three families with children in Massachusetts face food insecurity. Further, they lack consistent access to nutritious food. Families face challenges such as insufficient knowledge of available resources, financial constraints, time scarcity, and/or language barriers. Social determinants such as food insecurity have adverse consequences on child health outcomes.
The FAVORes workshop is an in-person educational program for caregivers of children at MEHC. It is a 4-session, group coaching workshop led by a Senior Patient Navigator who shares her own experiences with food insecurity and as a health coach. The workshop runs over 4 weeks, 1.5 hours each session, is taught in small groups, and is available in both English and Spanish.
This workshop is designed to empower caregivers of children. It shares simple tips and steps to help with meal planning, having family meals, and eating healthier. The workshop also encourages caregivers to learn from each other in a group setting. Specific topics covered include setting "S.M.A.R.T. goals" (Specific, Measurable, Achievable, Relevant, Time-bound), understanding community food resources, managing time for healthy eating, and connecting food to overall health and mental well-being. The overall hypothesis for the FAVORes study is that the workshop will lead to meaningful and positive changes for families struggling with food insecurity.
Study Aims:
- To examine the impact of the workshop on household food and nutrition security.
- To explore changes in caregivers' knowledge, beliefs, and skills related to healthy food access.
- Being tested
- FAVORes Workshop
- Keywords
- Nutrition Security, Food Insecurity, Group Coaching, Caregivers, Nutrition Education, Behavioral Intervention, Community-centered, Primary Care, Health-Related Social Needs, Food Access
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAVORes WorkshopBehavioural
The FAVORes (Food Access, Value, and Optimization of Resources) Workshop is a 4-week, in-person group coaching program for caregivers of children in food-insecure households. The intervention focuses on financial and nutrition literacy, community resource navigation, healthy eating habits, and setting family goals.
| Study group | Role | What they receive |
|---|---|---|
| FAVORes Workshop | Experimental | Participants will attend the FAVORes workshop, consisting of four weekly in-person group coaching sessions (1.5 hours each). Workshops are held at MEHC, led by a patient navigator, and are offered in English or in Spanish. Receives: Behavioral: FAVORes Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Household Food Security Status at Baseline
Mean score and proportion of participants classified by food security status based on the USDA Household Food Security Survey Module, 18-item version. Categorized by the raw score (0-18) into:
Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security
Measured: At baseline (week 1)
Household Food Security Status at Week 4
Mean score and proportion of participants classified by food security status based on the USDA Household Food Security Survey Module, 18-item version. Categorized by the raw score (0-18) into:
Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security
Measured: Week 4
Nutrition Security Status at Baseline
Mean score and proportion of participants classified as nutrition secure/insecure using the 4-item nutrition security screener developed by the Center for Nutrition and Health Impact. Categorized by the raw score (0-4) into:
0-2: Low nutrition security 3-4: High nutrition security
Measured: At baseline (week 1)
Nutrition Security Status at Week 4
Mean score and proportion of participants classified as nutrition secure/insecure using the 4-item nutrition security screener developed by the Center for Nutrition and Health Impact. Categorized by the raw score (0-4) into:
0-2: Low nutrition security 3-4: High nutrition security
Measured: Week 4
Secondary outcomes (7)
Participant reported confidence in setting S.M.A.R.T. goals at Week 4
Proportion of participants responding "Agree" or "Strongly Agree" to the statement about increased confidence after the workshop, measured using a 5-point Likert scale: "After this workshop, I feel more confident in setting S.M.A.R.T. goals for my family."
Measured: Week 4
Participant reported learning about new ways to make healthier food choices at Week 4
Proportion of participants responding "Agree" or "Strongly Agree" to the statement about learning healthier food choices for their family, measured on a 5-point Likert scale: "I learned new ways to make healthier food choices for my family."
Measured: Week 4
Participant reported knowledge about saving money on groceries in Week 4
Proportion of participants reporting "Agree" or "Strongly Agree" to the ability to save money/use food budget better following the intervention, by Likert scale: "This workshop taught me how to save money on groceries and use my food budget better."
Measured: Week 4
Participant reported knowledge of support programs/agencies in Week 4
Proportion of participants reporting "Agree" or "Strongly Agree" to the statement about increased knowledge about agencies and programs available, by Likert scale: "I know more about programs and agencies that can help my family with food and other needs."
Measured: Week 4
Participant reported improvement in family well-being in Week 4
Proportion of participants reporting "Agree" or "Strongly Agree" to the statement: "Overall, this workshop has given me tools and knowledge to improve my family's well-being."
Measured: Week 4
Participant reported workshop satisfaction in Week 4
Proportion of participants reporting "Satisfied" or "Very Satisfied" with the workshop; measured via a 5-point satisfaction scale: "Overall, I am satisfied with my participation in the FAVORes workshop."
Measured: Week 4
Participant reported likelihood of recommending workshop in Week 4
Mean numeric score (0-10) for likelihood to recommend the workshop, using the Net Promoter Score question: "How likely are you to recommend this workshop to a friend or family member?" 0 = very unlikely, 5 = neutral, and 10 = extremely likely.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start7 Oct 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
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 Boston Children's 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Wu, Boston Children's Hospital
- Investigators
- Allison J Wu, MD, MPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149350
- Sponsor's protocol ID
- IRB-P00051793
- Acronym
- FAVORes
- Status last verified
- Mar 2026
- First submitted
- 27 Aug 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Access, Value, and Optimization of Resources
- ClinicalTrials.gov ID
- NCT07149350
- Acronym / sponsor ID
- FAVORes / IRB-P00051793
- Keywords
- Nutrition Security, Food Insecurity, Group Coaching, Caregivers, Nutrition Education, Behavioral Intervention, Community-centered, Primary Care
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Sep 2025 (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 main goal of the study is to examine the potential benefits of an educational workshop designed to help and support caregivers of children in families that struggle to get enough healthy food. The main questions are:
- Does the FAVORes workshop impact household food and nutrition security?
- Does the workshop change caregivers' knowledge, beliefs, and skills related to healthy food access?
Participants will:
- Attend four weekly in-person sessions (in English or Spanish)
- Complete short surveys
- Be interviewed after the workshop is completed (optional)
Detailed description
The FAVORes (Food Access, Value, and Optimization of Resources) study at Boston Children's Martha Eliot Health Center (MEHC) aims to help families struggling with healthy food access. Over one in three families with children in Massachusetts face food insecurity. Further, they lack consistent access to nutritious food. Families face challenges such as insufficient knowledge of available resources, financial constraints, time scarcity, and/or language barriers. Social determinants such as food insecurity have adverse consequences on child health outcomes.
The FAVORes workshop is an in-person educational program for caregivers of children at MEHC. It is a 4-session, group coaching workshop led by a Senior Patient Navigator who shares her own experiences with food insecurity and as a health coach. The workshop runs over 4 weeks, 1.5 hours each session, is taught in small groups, and is available in both English and Spanish.
This workshop is designed to empower caregivers of children. It shares simple tips and steps to help with meal planning, having family meals, and eating healthier. The workshop also encourages caregivers to learn from each other in a group setting. Specific topics covered include setting "S.M.A.R.T. goals" (Specific, Measurable, Achievable, Relevant, Time-bound), understanding community food resources, managing time for healthy eating, and connecting food to overall health and mental well-being. The overall hypothesis for the FAVORes study is that the workshop will lead to meaningful and positive changes for families struggling with food insecurity.
Study Aims:
- To examine the impact of the workshop on household food and nutrition security.
- To explore changes in caregivers' knowledge, beliefs, and skills related to healthy food access.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FAVORes Workshop | Experimental | Behavioral: FAVORes WorkshopParticipants will attend the FAVORes workshop, consisting of four weekly in-person group coaching sessions (1.5 hours each). Workshops are held at MEHC, led by a patient navigator, and are offered in English or in Spanish. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years old
- Proficient in English or Spanish
- Attendance at the 1-hour "Towards Food Equity" Zoom session led by MEHC Social Work
Key exclusion criteria (1 listed)
- Inability or anticipated inability to attend scheduled in-person workshop sessions for the duration of the study.
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 |
|---|---|---|
| FAVORes WorkshopThe FAVORes (Food Access, Value, and Optimization of Resources) Workshop is a 4-week, in-person group coaching program for caregivers of children in food-insecure households. The intervention focuses on financial and nutrition literacy, community resource navigation, healthy eating habits, and setting family goals. | Behavioural | FAVORes Workshop |
Primary outcome
Household Food Security Status at Baseline
Time frame: At baseline (week 1)
Mean score and proportion of participants classified by food security status based on the USDA Household Food Security Survey Module, 18-item version. Categorized by the raw score (0-18) into: Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security
Household Food Security Status at Week 4
Time frame: Week 4
Mean score and proportion of participants classified by food security status based on the USDA Household Food Security Survey Module, 18-item version. Categorized by the raw score (0-18) into: Zero: High food security 1-2: Marginal food security 3-7: Low food security 8-18: Very low food security
Nutrition Security Status at Baseline
Time frame: At baseline (week 1)
Mean score and proportion of participants classified as nutrition secure/insecure using the 4-item nutrition security screener developed by the Center for Nutrition and Health Impact. Categorized by the raw score (0-4) into: 0-2: Low nutrition security 3-4: High nutrition security
Nutrition Security Status at Week 4
Time frame: Week 4
Mean score and proportion of participants classified as nutrition secure/insecure using the 4-item nutrition security screener developed by the Center for Nutrition and Health Impact. Categorized by the raw score (0-4) into: 0-2: Low nutrition security 3-4: High nutrition security
7 secondary outcomes
Participant reported confidence in setting S.M.A.R.T. goals at Week 4
Time frame: Week 4
Participant reported learning about new ways to make healthier food choices at Week 4
Time frame: Week 4
Participant reported knowledge about saving money on groceries in Week 4
Time frame: Week 4
Participant reported knowledge of support programs/agencies in Week 4
Time frame: Week 4
Participant reported improvement in family well-being in Week 4
Time frame: Week 4
Participant reported workshop satisfaction in Week 4
Time frame: Week 4
Participant reported likelihood of recommending workshop in Week 4
Time frame: Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
Related trials for Food Insecurity
Not yet recruiting
Health-Related Social Needs Food Boxes Delivery Program
Food Insecurity
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Active, not recruiting
Deliver-EE: Evaluating Effects of Meal Delivery
Healthy
Not yet recruiting
Nutrition Intervention Optimization to Better Utilize Resources and Support Health
Diabete Type 2, Obesity & Overweight
Active, not recruiting
Mobile Health Coping Intervention for Mothers Experiencing Food Insecurity
Food Insecurity
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.
Allison J Wu, MD, MPH principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAVORes Workshop in people with Food Insecurity and Health Behavior, 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?
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: enrolling by invitation, as of the sponsor's last update on 18 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Household Food Security Status at Baseline (time frame: At baseline (week 1)). The study lists 4 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 18 Mar 2026.