Family COMIDA (Consumo de Opciones Más Ideales De Alimentos) (Eating More Ideal Food Options)
NCT ID: NCT07144800
Last Updated: 2025-12-03
Study Results
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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RECRUITING
NA
1330 participants
INTERVENTIONAL
2025-08-22
2031-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Condition 1: Tele
Intervention for 6 months
Parent Weekly Individual Telephone Support
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
Child Education
6 weekly diet/PA education sessions ('Child Education')
Condition 3: Parent Counseling
Intervention for 6 months
Parent Initial Counseling
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
Parent Weekly Individual Telephone Support
Interventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual
Child Education
6 weekly diet/PA education sessions ('Child Education')
Parent Initial Counseling
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
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).
Condition 6: Group Support, Child Education, and Tele
Intervention for 6 months
Parent Weekly Individual Telephone Support
Interventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual
Child Education
6 weekly diet/PA education sessions ('Child Education')
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).
Condition 7: Group Support, Parent Counseling, and Tele
Intervention for 6 months
Parent Weekly Individual Telephone Support
Interventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual
Parent Initial Counseling
Interventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual
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).
Condition 8: Group Support, Parent Counseling, and Child Education
Intervention for 6 months
Child Education
6 weekly diet/PA education sessions ('Child Education')
Parent Initial Counseling
Interventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual
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).
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
Child Education
6 weekly diet/PA education sessions ('Child Education')
Parent Initial Counseling
Interventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
Yes
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Jennifer Leng, MD, MPH
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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25-003
Identifier Type: -
Identifier Source: org_study_id
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