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New treatment option for Obesity
Official title Family COMIDA (Consumo de Opciones Más Ideales De Alimentos) (Eating More Ideal Food Options)
ClinicalTrials.gov ID: NCT07144800
What this study is testing
- What it's testing
- 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 plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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)
You likely can't join if
- 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...
- 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
See the full eligibility criteria
Who can join
- 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)
What rules you out
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.