Family-Centered Intervention for the Reduction of Obesity among Hispanic Families, Family COMIDA Trial
This clinical trial studies how well a family-centered intervention (FCI) works in reducing obesity among Hispanic families. Childhood obesity is a significant predictor of obesity in adulthood. Parental obesity more than doubles the risk of future adult obesity among obese and nonobese children under age 10. This is in part due to genetics but also due to parent modeling of health behaviors, and the home environment. Obesity puts Hispanic adults and children at increased risk for heart disease and, among adults, for certain types of cancer. An FCI is a type of program that involves family (such as parents and caregivers) supporting their children to promote healthy habits. The FCI used in this trial, Family Consumo de Opciones Más Ideales De Alimentos (COMIDA), may work to reduce obesity among Hispanic families.
Inclusion Criteria
- PHASE 1: Age >= 18 years (per self-report)
- PHASE 1: Self-identifies as Hispanic/Latino (per self-report)
- PHASE 1: Seeking, or has used, services at the Ventanillas de Salud (VDS) or Memorial Sloan Kettering's Mobile Health Unit (MHU) (per self-report)
- PHASE 1: Is the parent or primary caregiver for at least one child aged 8-12 living in their household (per self-report)
- PHASE 1: Screens as obese (body mass index [BMI] > 30 kg/m^2) or overweight (BMI of 25 - 29.9 kg/m^2) (per height and weight measurement in person or per self-report)
- PHASE 1: Owns a cell phone capable of receiving text messages (per self-report)
- PHASE 1: Owns an internet connected device (e.g. cell phone, tablet, etc.) capable of conducting videoconference calls (per self-report)
- PHASE 1: Agrees to be audio-recorded (per self-report)
- PHASE 2 (PARENT PARTICIPANTS): Age >= 18 years (per self-report)
- PHASE 2 (PARENT PARTICIPANTS): Self-identifies as Hispanic/Latino (per self-report)
- PHASE 2 (PARENT PARTICIPANTS): Seeking, or has used, services at the VDS or MHU (per self-report)
- PHASE 2 (PARENT PARTICIPANTS): Is the parent or primary caregiver for at least one child aged 8-12 living in their household (per self-report)
- PHASE 2 (PARENT PARTICIPANTS): Screens as obese (BMI > 30 kg/m^2) or overweight (BMI of 25 - 29.9 kg/m^2) (per height and weight measurement in person)
- PHASE 2 (PARENT PARTICIPANTS): Owns a cell phone capable of receiving text messages (per self-report)
- PHASE 2 (PARENT PARTICIPANTS): Owns an internet connected device (e.g. cell phone, tablet, etc.) capable of conducting videoconference calls (per self-report)
- PHASE 2 (PARENT PARTICIPANTS): Agrees to be audio-recorded (per self-report)
- PHASE 2 (CHILD PARTICIPANTS): Age 8-12 years (per parent self-report)
- PHASE 2 (CHILD PARTICIPANTS): 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)
- PHASE 1: 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)
- PHASE 1: Has dietary restrictions, i.e. liquid diet, that may affect diet and study participation (per self-report)
- PHASE 1: Has a household member who has already participated or agreed to participate in this study program (per self-report)
- PHASE 1: Prior participation in one of our preliminary studies, e.g., COMIDA, Salud y Nutrición para todos (SANOS), Family COMIDA (per self-report) and any related focus groups
- PHASE 1: Works for or with the VDS or MHU (per self-report)
- PHASE 1: 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)
- PHASE 2 (PARENT PARTICIPANT): For women, is lactating (per self-report)
- PHASE 2 (PARENT PARTICIPANT): 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)
- PHASE 2 (PARENT PARTICIPANT): Has dietary restrictions, i.e., liquid diet, that may affect diet and study participation (per self-report)
- PHASE 2 (PARENT PARTICIPANT): Has physical activity restrictions, i.e., handicapped or mobility issues, that may affect physical activity participation (increasing step counts; per self-report)
- PHASE 2 (PARENT PARTICIPANT): Has a household member who has already participated or agreed to participate in this study program (per self-report)
- PHASE 2 (PARENT PARTICIPANT): Prior participation in one of our preliminary studies, e.g., COMIDA, SANOS, Family COMIDA (per self-report) and any related focus groups
- PHASE 2 (PARENT PARTICIPANT): Works for or with the VDS or MHU (per self-report)
- PHASE 2 (PARENT PARTICIPANT): 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 PARTICIPANTS): Has dietary restrictions, i.e., liquid diet, that may affect diet and study participation (per parent self-report)
- PHASE 2 (CHILD PARTICIPANTS): Has physical activity restrictions, i.e., handicapped or mobility issues, that may affect physical activity participation (per parent self-report)
- PHASE 2 (CHILD PARTICIPANTS): Has an eating disorder (per parent self-report)
- PHASE 2 (CHILD PARTICIPANTS): Is underweight (per parent self-report)
Additional locations may be listed on ClinicalTrials.gov for NCT07144800.
Locations matching your search criteria
United States
New York
New York
PRIMARY OBJECTIVES:
I. To utilize an optimization trial to identify the most effective, mHealth weight loss/obesity prevention family-centered intervention (FCI) for Hispanic families in the United States (U.S.).
II. To conduct mediation analyses to assess whether changes in mediators (3 month [mo] post-intake) among parents, including self-efficacy, outcome expectancies, and nutrition knowledge, attitudes, and beliefs (key social cognitive theory [SCT] concepts), and among families – family functioning (family systems theory [FST] concept) (measured by the Spanish version of the McMaster Family Assessment Device [FAD], General Functioning scale), are associated with intervention components, and whether changes in mediators are linked to study outcomes.
III. To collect cost data to estimate the cost and incremental cost-effectiveness of intervention component combinations.
OUTLINE:
PHASE 1: Participants attend a focus group for refinement of Family COMIDA materials on study.
PHASE 2: Participants are randomized to 1 of 16 conditions.
CONDITION 1: Participants receive a baseline package that includes: 1) Written materials on healthy lifestyle information and resources; 2) Access to the Family COMIDA website; 3) Self-monitoring tools for both parents and children; and 4) Parent participants receive healthy eating/PA Spanish language (English available) text messages three times weekly (TIW). Parent participants also complete a counseling session over 20-30 minutes on study and receive support via videoconference or telephone (tele) weekly for 24 weeks to review/integrate new diet/physical activity (PA) knowledge and skills into family’s routines, and encourage parents (with their families) to seek opportunities for modeling. Child participants also receive 6 weekly diet/PA education sessions on study.
CONDITION 2: Parent participants complete a counseling session over 20-30 minutes on study. Child participants receive 6 weekly diet/PA education sessions on study. All participants also receive baseline package as in Condition 1.
CONDITION 3: Parent participants complete a counseling session over 20-30 minutes on study and receive tele support weekly for 24 weeks. All participants also receive baseline package as in Condition 1.
CONDITION 4: Parent participants complete a counseling session over 20-30 minutes on study. All participants also receive baseline package as in Condition 1.
CONDITION 5: Child participants receive 6 weekly diet/PA education sessions on study. Parent participants receive tele support weekly for 24 weeks. All participants also receive baseline package as in Condition 1.
CONDITION 6: Child participants receive 6 weekly diet/PA education sessions on study. All participants also receive baseline package as in Condition 1.
CONDITION 7: Parent participants receive tele support weekly for 24 weeks. All participants also receive baseline package as in Condition 1.
CONDITION 8: Participants receive baseline package as in Condition 1.
CONDITION 9: Parent participants participate in support group sessions weekly on study, complete a counseling session over 20-30 minutes on study, and receive tele support weekly for 24 weeks. Child participants receive 6 weekly diet/PA education sessions on study. All participants also receive baseline package as in Condition 1.
CONDITION 10: Parent participants participate in support group sessions weekly and complete a counseling session over 20-30 minutes on study. Child participants receive 6 weekly diet/PA education sessions on study. All participants also receive baseline package as in Condition 1.
CONDITION 11: Parent participants participate in support group sessions weekly on study, complete a counseling session over 20-30 minutes on study, and receive tele support weekly for 24 weeks. All participants also receive baseline package as in Condition 1.
CONDITION 12: Parent participants participate in support group sessions weekly and complete a counseling session over 20-30 minutes on study. All participants also receive baseline package as in Condition 1.
CONDITION 13: Parent participants participate in support group sessions weekly on study and receive tele support weekly for 24 weeks. Child participants receive 6 weekly diet/PA education sessions on study. All participants also receive baseline package as in Condition 1.
CONDITION 14: Parent participants participate in support group sessions weekly on study. Child participants receive 6 weekly diet/PA education sessions on study. All participants also receive baseline package as in Condition 1.
CONDITION 15: Parent participants participate in support group sessions weekly on study and receive tele support weekly for 24 weeks. All participants also receive baseline package as in Condition 1.
CONDITION 16: Parent participants participate in support group sessions weekly on study. All participants also receive baseline package as in Condition 1.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorJennifer Leng
- Primary ID25-003
- Secondary IDsNCI-2025-06372
- ClinicalTrials.gov IDNCT07144800