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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Weight Loss; Obesity; Child Obesity

Treatments: Behavioral: Parent Initial Counseling; Behavioral: Parent Monthly Group Support; Behavioral: Child Education; Behavioral: Parent Weekly Individual Telephone Support

Study type: Interventional

Funder types: Other

Identifiers

NCT07144800

25-003

Details and patient eligibility

About

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.

Enrollment: 1,319 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,319 participants in 8 patient groups

Condition 1: Tele

Experimental group

Description:

Intervention for 6 months more or less

Treatment:

Behavioral: Parent Weekly Individual Telephone Support

Condition 2: Child Education

Experimental group

Description:

Intervention for 6 months

Treatment:

Behavioral: Child Education

Condition 3: Parent Counseling

Experimental group

Description:

Intervention for 6 months

Treatment:

Behavioral: Parent Initial Counseling

Condition 4: Counseling, Child Education, and Tele

Experimental group

Description:

Intervention for 6 months

Treatment:

Behavioral: Parent Weekly Individual Telephone Support

Behavioral: Child Education

Behavioral: Parent Initial Counseling

Condition 5: Group Support

Experimental group

Description:

Intervention for 6 months

Treatment:

Behavioral: Parent Monthly Group Support

Condition 6: Group Support, Child Education, and Tele

Experimental group

Description:

Intervention for 6 months

Treatment:

Behavioral: Parent Weekly Individual Telephone Support

Behavioral: Child Education

Behavioral: Parent Monthly Group Support

Condition 7: Group Support, Parent Counseling, and Tele

Experimental group

Description:

Intervention for 6 months

Treatment:

Behavioral: Parent Weekly Individual Telephone Support

Behavioral: Parent Monthly Group Support

Behavioral: Parent Initial Counseling

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

Experimental group

Description:

Intervention for 6 months

Treatment:

Behavioral: Child Education

Behavioral: Parent Monthly Group Support

Behavioral: Parent Initial Counseling