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

Обзор

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.

Вмешательства

• Поведенческое Parent Weekly Individual Telephone Support
  Interventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual
• Поведенческое Child Education
  6 weekly diet/PA education sessions ('Child Education')
• Поведенческое Parent Initial Counseling
  Interventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual
• Поведенческое 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).

Первичные конечные точки

• Percentage weight loss from baseline among participants [Срок оценки: 6 months]

Критерии участия

Критерии включения

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)

Критерии исключения

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York

Публикации

• Leng J, Gonzalez-Sarinana LI, Minaya S, Narang B, Gilliland J, Gany F. Finding Balance: Insights from Mexican Heritage Families on Living a Healthy Lifestyle in New York City. J Community Health. 2026 Jul 23. doi: 10.1007/s10900-026-01607-5. Online ahead of print. PMID 42493744

Идентификаторы

NCT: NCT07144800 · 25-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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