RECRUITINGINTERVENTIONAL
Family COMIDA (Consumo de Opciones Más Ideales De Alimentos) (Eating More Ideal Food Options)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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)
Who Should NOT Join This Trial:
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)
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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)
Treatments Being Tested
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).
Locations (1)
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States