Family COMIDA (Consumo de Opciones Más Ideales De Alimentos) (Eating More Ideal Food Options)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,319
- 试验地点
- 1
- 主要终点
- Percentage weight loss from baseline among participants
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
Condition 1: Tele
Intervention for 6 months more or less
干预措施: Parent Weekly Individual Telephone Support (Behavioral)
Condition 2: Child Education
Intervention for 6 months
干预措施: Child Education (Behavioral)
Condition 3: Parent Counseling
Intervention for 6 months
干预措施: Parent Initial Counseling (Behavioral)
Condition 4: Counseling, Child Education, and Tele
Intervention for 6 months
干预措施: Parent Weekly Individual Telephone Support (Behavioral)
Condition 4: Counseling, Child Education, and Tele
Intervention for 6 months
干预措施: Child Education (Behavioral)
Condition 4: Counseling, Child Education, and Tele
Intervention for 6 months
干预措施: Parent Initial Counseling (Behavioral)
Condition 5: Group Support
Intervention for 6 months
干预措施: Parent Monthly Group Support (Behavioral)
Condition 6: Group Support, Child Education, and Tele
Intervention for 6 months
干预措施: Parent Weekly Individual Telephone Support (Behavioral)
Condition 6: Group Support, Child Education, and Tele
Intervention for 6 months
干预措施: Child Education (Behavioral)
Condition 6: Group Support, Child Education, and Tele
Intervention for 6 months
干预措施: Parent Monthly Group Support (Behavioral)
Condition 7: Group Support, Parent Counseling, and Tele
Intervention for 6 months
干预措施: Parent Weekly Individual Telephone Support (Behavioral)
Condition 7: Group Support, Parent Counseling, and Tele
Intervention for 6 months
干预措施: Parent Initial Counseling (Behavioral)
Condition 7: Group Support, Parent Counseling, and Tele
Intervention for 6 months
干预措施: Parent Monthly Group Support (Behavioral)
Condition 8: Group Support, Parent Counseling, and Child Education
Intervention for 6 months
干预措施: Child Education (Behavioral)
Condition 8: Group Support, Parent Counseling, and Child Education
Intervention for 6 months
干预措施: Parent Initial Counseling (Behavioral)
Condition 8: Group Support, Parent Counseling, and Child Education
Intervention for 6 months
干预措施: Parent Monthly Group Support (Behavioral)
结局指标
主要结局
Percentage weight loss from baseline among participants
时间窗: 6 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)
次要结局
未报告次要终点