Family COMIDA (Consumo de Opciones Más Ideales De Alimentos) (Eating More Ideal Food Options)

Overview

The purpose of this study is to determine the most effective family-centered intervention (FCI) for weight loss and obesity prevention in Hispanic families. FCI is a type of program that involves family (such as parents and caregivers) supporting their children to promote healthy habits.

Interventions

• Behavioral Parent Weekly Individual Telephone Support
  Interventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual
• Behavioral Child Education
  6 weekly diet/PA education sessions ('Child Education')
• Behavioral Parent Initial Counseling
  Interventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual
• Behavioral Parent Monthly Group Support
  Parents will be invited to join a Spanish language (English if preferred) weekly group videoconference (can join by phone if preferred).

Primary outcome measures

• Percentage weight loss from baseline among participants [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

Phase 1

• Age >= 18 years (per self-report)
• Self-identifies as Hispanic/Latino (per self-report)
• Seeking, or has used, services at the VDS or MHU (per self-report)
• Is the parent or primary caregiver for at least one child aged 8-12 living in their household (per self-report)
• Screens as obese (BMI > 30 kg/m2) or overweight (BMI of 25 - 29.9 kg/m2) (per height and weight measurement in person or per self-report)
• Owns a cell phone capable of receiving text messages (per self-report)
• Owns an internet connected device (e.g. cell phone, tablet, etc.) capable of conducting videoconference calls (per self-report)
• Agrees to be audio-recorded (per self-report)

Phase 2 (parent participants)

• Age >= 18 years (per self-report)
• Self-identifies as Hispanic/Latino (per self-report)
• Seeking, or has used, services at the VDS or MHU (per self-report)
• Is the parent or primary caregiver for at least one child aged 8-12 living in their household (per self-report)
• Screens as obese (BMI > 30 kg/m2) or overweight (BMI of 25 - 29.9 kg/m2) (per height and weight measurement in person or remotely)
• Owns a cell phone capable of receiving text messages (per self-report)
• Owns an internet connected device (e.g. cell phone, tablet, etc.) capable of conducting videoconference calls (per self-report)
• Agrees to be audio-recorded (per self-report)

Phase 2 (child participants)

• Age 8-12 years (per parent self-report)
• Has a parent or primary caregiver who is eligible and participating in Phase 2 (per parent self-report)

Exclusion criteria

Phase 1

• Is pregnant or might be pregnant (per self-report)
• Presence of a chronic disease such as cancer, kidney disease, liver disease, etc. (individuals with hypertension and diabetes mellitus may still participate) that may affect diet and study participation (per self-report)
• Has dietary restrictions, i.e. liquid diet, that may affect diet and study participation (per self-report)
• Has a household member who has already participated or agreed to participate in this study program (per self-report)
• Prior participation in one of our preliminary studies, e.g., COMIDA, SANOS, Family COMIDA (per self-report) and any related focus groups
• Works for or with the VDS or MHU (per self-report)
• Presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection (per study team)

Phase 2 (parent participant)

• Is pregnant or might be pregnant (per self-report)
• For women, is lactating (per self-report)
• Presence of a chronic disease such as cancer, kidney disease, liver disease, etc. (individuals with hypertension and diabetes mellitus may still participate) that may affect diet and study participation (per self-report)
• Has dietary restrictions, i.e., liquid diet, that may affect diet and study participation (per self-report)
• Has physical activity restrictions, i.e., handicapped or mobility issues, that may affect physical activity participation (increasing step counts; per self-report)
• Has a household member who has already participated or agreed to participate in this study program (per self-report)
• Prior participation in one of our preliminary studies, e.g., COMIDA, SANOS, Family COMIDA (per self-report) and any related focus groups
• Works for or with the VDS or MHU (per self-report)
• Presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection (per study team)

Phase 2 (child participant)

• Has dietary restrictions, i.e., liquid diet, that may affect diet and study participation (per parent self-report)
• Has physical activity restrictions, i.e., handicapped or mobility issues, that may affect physical activity participation (per parent self-report)
• Has an eating disorder (per parent self-report)
• Is underweight (per parent self-report)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York

Publications

• Leng J, Gonzalez-Sarinana LI, Minaya S, Narang B, Gilliland J, Gany F. Finding Balance: Insights from Mexican Heritage Families on Living a Healthy Lifestyle in New York City. J Community Health. 2026 Jul 23. doi: 10.1007/s10900-026-01607-5. Online ahead of print. PMID 42493744

Identifiers

NCT: NCT07144800 · 25-003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗