Child Obesity, Obesity, Weight Loss
Conditions
Keywords
child obesity, obesity, weight loss, Memorial Sloan Kettering Cancer Center, 25-003
Brief summary
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.
Interventions
BEHAVIORALParent Weekly Individual Telephone Support
Interventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual
BEHAVIORALChild Education
6 weekly diet/PA education sessions ('Child Education')
BEHAVIORALParent Initial Counseling
Interventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual
BEHAVIORALParent Monthly Group Support
Parents will be invited to join a Spanish language (English if preferred) weekly group videoconference (can join by phone if preferred).
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage weight loss from baseline among participants | 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) |
Countries
United States
Contacts
CONTACTJennifer Leng, MD, MPH
CONTACTFrancesca Gany, MD, MS
PRINCIPAL_INVESTIGATORJennifer Leng, MD, MPH
Memorial Sloan Kettering Cancer Center
Outcome results
None listed