Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Condition 1: Tele | Experimental | Intervention for 6 months more or less |
|
| Condition 2: Child Education | Experimental | Intervention for 6 months |
|
| Condition 3: Parent Counseling | Experimental | Intervention for 6 months |
|
| Condition 4: Counseling, Child Education, and Tele | Experimental | Intervention for 6 months |
|
| Condition 5: Group Support | Experimental | Intervention for 6 months |
|
| Condition 6: Group Support, Child Education, and Tele | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parent Weekly Individual Telephone Support | Behavioral | Interventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage weight loss from baseline among participants | 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) | 6 months |
Not provided
Not provided
Inclusion Criteria:
Phase 1
Phase 2 (parent participants)
Phase 2 (child participants)
Exclusion Criteria:
Phase 1
Phase 2 (parent participant)
Phase 2 (child participant)
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Leng, MD, MPH | Contact | 646-888-8057 | lengj@mskcc.org | |
| Francesca Gany, MD, MS | Contact | 646-888-8054 | ganyf@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Leng, MD, MPH | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting | New York | New York | 10065 | United States |
Not provided
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
Not provided
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Intervention for 6 months |
|
| Condition 7: Group Support, Parent Counseling, and Tele | Experimental | Intervention for 6 months |
|
| Condition 8: Group Support, Parent Counseling, and Child Education | Experimental | Intervention for 6 months |
|
|
| Child Education | Behavioral | 6 weekly diet/PA education sessions ('Child Education') |
|
| Parent Initial Counseling | Behavioral | Interventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual |
|
|
| Parent Monthly Group Support | Behavioral | Parents will be invited to join a Spanish language (English if preferred) weekly group videoconference (can join by phone if preferred). |
|
|
| ID | Term |
|---|---|
| D009765 | Obesity |
| D063766 | Pediatric Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
Not provided
Not provided
| ID | Term |
|---|---|
| C071468 | 2,2,2',4'-tetrachloroacetophenone |
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
Not provided
Not provided