Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07144800

Recruiting nowNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersAccepted
ConditionObesity, Child Obesity, Weight Loss

Full registry 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)

Treatments and study arms

Parent Weekly Individual Telephone Support

Behavioral

Interventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual

Child Education

Behavioral

6 weekly diet/PA education sessions ('Child Education')

Parent Initial Counseling

Behavioral

Interventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual

Parent Monthly Group Support

Behavioral

Parents will be invited to join a Spanish language (English if preferred) weekly group videoconference (can join by phone if preferred).

Primary outcomes

Percentage weight loss from baseline among participants6 months

To utilize an optimization trial to identify the most effective, mHealth weight loss/obesity prevention FCI for Hispanic families in the U.S. 5% weight loss from baseline among overweight/obese parents (a percentage loss associated with numerous health benefits)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Memorial Sloan Kettering Cancer Center (All Protocol Activities)🇺🇸 New York, New York, United States
Jennifer Leng, MD, MPHContact