NCT07144800

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,319

participants targeted

Target at P75+ for not_applicable obesity

Timeline
63mo left

Started Aug 2025

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Aug 2025Jul 2031

Study Start

First participant enrolled

August 22, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2025

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2031

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

4.9 years

First QC Date

August 25, 2025

Last Update Submit

April 14, 2026

Conditions

ObesityChild ObesityWeight Loss

Keywords

child obesityobesityweight lossMemorial Sloan Kettering Cancer Center25-003

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (8)

Condition 1: Tele

EXPERIMENTAL

Intervention for 6 months more or less

Behavioral: Parent Weekly Individual Telephone Support

Condition 2: Child Education

EXPERIMENTAL

Intervention for 6 months

Behavioral: Child Education

Condition 3: Parent Counseling

EXPERIMENTAL

Intervention for 6 months

Behavioral: Parent Initial Counseling

Condition 4: Counseling, Child Education, and Tele

EXPERIMENTAL

Intervention for 6 months

Behavioral: Parent Weekly Individual Telephone SupportBehavioral: Child EducationBehavioral: Parent Initial Counseling

Condition 5: Group Support

EXPERIMENTAL

Intervention for 6 months

Behavioral: Parent Monthly Group Support

Condition 6: Group Support, Child Education, and Tele

EXPERIMENTAL

Intervention for 6 months

Behavioral: Parent Weekly Individual Telephone SupportBehavioral: Child EducationBehavioral: Parent Monthly Group Support

Condition 7: Group Support, Parent Counseling, and Tele

EXPERIMENTAL

Intervention for 6 months

Behavioral: Parent Weekly Individual Telephone SupportBehavioral: Parent Initial CounselingBehavioral: Parent Monthly Group Support

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

EXPERIMENTAL

Intervention for 6 months

Behavioral: Child EducationBehavioral: Parent Initial CounselingBehavioral: Parent Monthly Group Support

Interventions

Parent Weekly Individual Telephone SupportBEHAVIORAL

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

Also known as: Tele
Condition 1: TeleCondition 4: Counseling, Child Education, and TeleCondition 6: Group Support, Child Education, and TeleCondition 7: Group Support, Parent Counseling, and Tele
Child EducationBEHAVIORAL

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

Condition 2: Child EducationCondition 4: Counseling, Child Education, and TeleCondition 6: Group Support, Child Education, and TeleCondition 8: Group Support, Parent Counseling, and Child Education
Parent Monthly Group SupportBEHAVIORAL

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

Also known as: Group
Condition 5: Group SupportCondition 6: Group Support, Child Education, and TeleCondition 7: Group Support, Parent Counseling, and TeleCondition 8: Group Support, Parent Counseling, and Child Education
Parent Initial CounselingBEHAVIORAL

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

Also known as: Parent Counseling
Condition 3: Parent CounselingCondition 4: Counseling, Child Education, and TeleCondition 7: Group Support, Parent Counseling, and TeleCondition 8: Group Support, Parent Counseling, and Child Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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)
  • 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)
  • +6 more criteria

You may not qualify 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 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)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Related Links

MeSH Terms

Conditions

ObesityPediatric ObesityWeight Loss

Interventions

2,2,2',4'-tetrachloroacetophenonePopulation Groups

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • Jennifer Leng, MD, MPH

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Leng, MD, MPH

CONTACT

646-888-8057lengj@mskcc.org

Francesca Gany, MD, MS

CONTACT

646-888-8054ganyf@mskcc.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2025

First Posted

August 28, 2025

Study Start

August 22, 2025

Primary Completion (Estimated)

July 31, 2030

Study Completion (Estimated)

July 31, 2031

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Locations

US(1)