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

NCT ID: NCT07144800

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-22

Study Completion Date

2031-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Child Obesity Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Condition 1: Tele

Intervention for 6 months

Group Type EXPERIMENTAL

Parent Weekly Individual Telephone Support

Intervention Type BEHAVIORAL

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

Condition 2: Child Education

Intervention for 6 months

Group Type EXPERIMENTAL

Child Education

Intervention Type BEHAVIORAL

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

Condition 3: Parent Counseling

Intervention for 6 months

Group Type EXPERIMENTAL

Parent Initial Counseling

Intervention Type BEHAVIORAL

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

Condition 4: Counseling, Child Education, and Tele

Intervention for 6 months

Group Type EXPERIMENTAL

Parent Weekly Individual Telephone Support

Intervention Type BEHAVIORAL

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

Child Education

Intervention Type BEHAVIORAL

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

Parent Initial Counseling

Intervention Type BEHAVIORAL

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

Condition 5: Group Support

Intervention for 6 months

Group Type EXPERIMENTAL

Parent Monthly Group Support

Intervention Type BEHAVIORAL

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

Condition 6: Group Support, Child Education, and Tele

Intervention for 6 months

Group Type EXPERIMENTAL

Parent Weekly Individual Telephone Support

Intervention Type BEHAVIORAL

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

Child Education

Intervention Type BEHAVIORAL

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

Parent Monthly Group Support

Intervention Type BEHAVIORAL

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

Condition 7: Group Support, Parent Counseling, and Tele

Intervention for 6 months

Group Type EXPERIMENTAL

Parent Weekly Individual Telephone Support

Intervention Type BEHAVIORAL

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

Parent Initial Counseling

Intervention Type BEHAVIORAL

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

Parent Monthly Group Support

Intervention Type BEHAVIORAL

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

Condition 8: Group Support, Parent Counseling, and Child Education

Intervention for 6 months

Group Type EXPERIMENTAL

Child Education

Intervention Type BEHAVIORAL

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

Parent Initial Counseling

Intervention Type BEHAVIORAL

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

Parent Monthly Group Support

Intervention Type BEHAVIORAL

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

Interventions

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Parent Weekly Individual Telephone Support

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

Intervention Type BEHAVIORAL

Child Education

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

Intervention Type BEHAVIORAL

Parent Initial Counseling

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

Intervention Type 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).

Intervention Type BEHAVIORAL

Other Intervention Names

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Tele Parent Counseling Group

Eligibility Criteria

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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)
* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Leng, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jennifer Leng, MD, MPH

Role: CONTACT

646-888-8057

Francesca Gany, MD, MS

Role: CONTACT

646-888-8054

Facility Contacts

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Jennifer Leng, MD, MPH

Role: primary

646-888-8057

Related Links

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https://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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25-003

Identifier Type: -

Identifier Source: org_study_id

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