Family COMIDA — helping Hispanic families choose healthier foods to prevent and reduce obesity

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

This program tests family-centered support (parent counseling, weekly phone coaching, monthly group sessions, and child education) to help Hispanic parents/caregivers and their 8–12-year-old children prevent or reduce obesity.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1319 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Memorial Sloan Kettering Cancer Center (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT07144800 on ClinicalTrials.gov

What this trial studies

Family COMIDA compares different family-centered interventions to find which approach best supports weight loss and obesity prevention in Hispanic families. The program delivers parent initial counseling, weekly individual telephone support, monthly parent group support, and education sessions for children. Eligible participants are Hispanic/Latino adults who are parents or primary caregivers of at least one child aged 8–12 and who are overweight or have obesity. All protocol activities are conducted at Memorial Sloan Kettering Cancer Center and sessions may be audio-recorded for program fidelity.

Who should consider this trial

Good fit: Hispanic/Latino adults (≥18) who are parents or primary caregivers of at least one child aged 8–12, who are overweight or have obesity, and who have a cell phone and an internet-connected device for videoconferencing.

Not a fit: People who are not Hispanic/Latino, who do not care for an eligible 8–12-year-old child, who are normal weight, or who lack phone/internet access are unlikely to be eligible or to benefit from this program.

Why it matters

Potential benefit: If successful, families could adopt healthier eating habits that lead to weight loss in parents and lower obesity risk for children.

How similar studies have performed: Previous family-centered and parent-focused interventions have shown meaningful improvements in parent and child weight and health behaviors, so this program builds on existing evidence.

Eligibility criteria

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)

Where this trial is running

New York, New York

• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Jennifer Leng, MD, MPH — Memorial Sloan Kettering Cancer Center
• Study coordinator: Jennifer Leng, MD, MPH

Conditions Obesity; Child Obesity; Weight Loss; child obesity; obesity; weight loss; Memorial Sloan Kettering Cancer Center; 25-003