Recruiting

Family-Centered Intervention

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07144800

Conditions

Obesity

Child Obesity

Weight Loss

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Parent Weekly Individual Telephone Support

Child Education

Parent Initial Counseling

Parent Monthly Group Support

Study Details

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.

Conditions

Obesity

Child Obesity

Weight Loss

Study ID

NCT07144800

Start date

Aug 22, 2025

Status verified date

Apr, 2026

Completion date

Jul 31, 2031

Anticipated

Primary completion date

Jul 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

1319 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Condition 1: Tele

Intervention for 6 months more or less

experimental: Condition 2: Child Education

Intervention for 6 months

experimental: Condition 3: Parent Counseling

Intervention for 6 months

experimental: Condition 4: Counseling, Child Education, and Tele

Intervention for 6 months

experimental: Condition 5: Group Support

Intervention for 6 months

experimental: Condition 6: Group Support, Child Education, and Tele

Intervention for 6 months

experimental: Condition 7: Group Support, Parent Counseling, and Tele

Intervention for 6 months

experimental: Condition 8: Group Support, Parent Counseling, and Child Education

Intervention for 6 months

Interventions

Parent Weekly Individual Telephone Support

Interventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual

Child Education

6 weekly diet/PA education sessions ('Child Education')

Parent Initial Counseling

Interventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual

Parent Monthly Group Support

Parents will be invited to join a Spanish language (English if preferred) weekly group videoconference (can join by phone if preferred).

Primary outcome measure

  • Percentage weight loss from baseline among participants [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Jennifer Leng, MD, MPH

646-888-8057lengj@mskcc.org

Francesca Gany, MD, MS

646-888-8054ganyf@mskcc.org

Locations

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Jennifer Leng, MD, MPH

646-888-8057

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

  • child obesity
  • obesity
  • weight loss
  • Memorial Sloan Kettering Cancer Center
  • 25-003

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-04-15.