RecruitingNot ApplicableNCT07144800
Family COMIDA (Consumo de Opciones Más Ideales De Alimentos) (Eating More Ideal Food Options)
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
1,319 participants
Start Date
Aug 22, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria21
- 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 Criteria23
- 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)
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Interventions
BEHAVIORALParent Weekly Individual Telephone Support
Interventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual
BEHAVIORALChild Education
6 weekly diet/PA education sessions ('Child Education')
BEHAVIORALParent Initial Counseling
Interventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual
BEHAVIORALParent Monthly Group Support
Parents will be invited to join a Spanish language (English if preferred) weekly group videoconference (can join by phone if preferred).
Locations(1)
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NCT07144800
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