NCT07149350

Brief 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. 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)

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Oct 2025Dec 2026

First Submitted

Initial submission to the registry

August 27, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 2, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 7, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

August 27, 2025

Last Update Submit

March 17, 2026

Conditions

Keywords

Nutrition SecurityFood InsecurityGroup CoachingCaregiversNutrition EducationBehavioral InterventionCommunity-centeredPrimary CareHealth-Related Social NeedsFood Access

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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

    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

    Week 4

Secondary Outcomes (7)

  • Participant reported confidence in setting S.M.A.R.T. goals at Week 4

    Week 4

  • Participant reported learning about new ways to make healthier food choices at Week 4

    Week 4

  • Participant reported knowledge about saving money on groceries in Week 4

    Week 4

  • Participant reported knowledge of support programs/agencies in Week 4

    Week 4

  • Participant reported improvement in family well-being in Week 4

    Week 4

  • +2 more secondary outcomes

Study Arms (1)

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.

Behavioral: FAVORes Workshop

Interventions

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.

FAVORes Workshop

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- Inability or anticipated inability to attend scheduled in-person workshop sessions for the duration of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Martha Eliot Health Center

Jamaica Plain, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Allison J Wu, MD, MPH

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 27, 2025

First Posted

September 2, 2025

Study Start

October 7, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations