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NCT Number: NCT07144800

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, 10065, United States

Location status: Recruiting

Location contact

Jennifer Leng, MD, MPH

CONTACT

646-888-8057

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Parent Weekly Individual Telephone Support

Behavioral

Interventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual

Other names: Tele

Child Education

Behavioral

6 weekly diet/PA education sessions ('Child Education')

Parent Initial Counseling

Behavioral

Interventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual

Other names: Parent Counseling

Parent Monthly Group Support

Behavioral

Parents will be invited to join a Spanish language (English if preferred) weekly group videoconference (can join by phone if preferred).

Other names: Group

Primary outcomes

  1. Percentage weight loss from baseline among participants

    Time frame: 6 months

    To utilize an optimization trial to identify the most effective, mHealth weight loss/obesity prevention FCI for Hispanic families in the U.S. 5% weight loss from baseline among overweight/obese parents (a percentage loss associated with numerous health benefits)

Study contacts

Contact information is provided by the study sponsor or research team.

Francesca Gany, MD, MS

CONTACT

[email protected]

646-888-8054

Jennifer Leng, MD, MPH

CONTACT

[email protected]

646-888-8057

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
Aug 28, 2025
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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