ObesityNCT07144800
Family COMIDA (Consumo de Opciones Más Ideales De Alimentos) (Eating More Ideal Food Options)
A study testing Parent Weekly Individual Telephone Support, Child Education and Parent Initial Counseling in people with Obesity and Child Obesity, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Child Obesity, Weight Loss
- What is being tested?
- Parent Weekly Individual Telephone Support, Child Education and Parent Initial Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,319 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2025to 31 Jul 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 21Show fewer
- 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)
Who cannot join
- 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
Show all 25Show fewer
- 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)
- Has been prescribed Ozempic, Wegovy, Mounjaro, Rybelsus, Trulicity (or other GLP 1 receptor agonist), or any other drug to treat obesity (per self-report) or (if previously prescribed) 7 weeks have not passed since the last dose was taken.
- Has undergone weight loss/bariatric surgery (RYBG, gastric banding, sleeve gastrectomy, balloon, etc.) or is planning to undergo such surgery in the next 12 months (per self-report)
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Jennifer Leng, MD, MPH, 646-888-8057
About this study
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
- Being tested
- Parent Weekly Individual Telephone Support, Child Education, Parent Initial Counseling, Parent Monthly Group Support
- Keywords
- child obesity, obesity, weight loss, Memorial Sloan Kettering Cancer Center, 25-003
- Medical subject headings
- Obesity, Pediatric Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Weekly Individual Telephone SupportBehavioural
Also called Tele
Interventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual
Child EducationBehavioural
6 weekly diet/PA education sessions ('Child Education')
Parent Initial CounselingBehavioural
Also called Parent Counseling
Interventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual
Parent Monthly Group SupportBehavioural
Also called Group
Parents will be invited to join a Spanish language (English if preferred) weekly group videoconference (can join by phone if preferred).
| Study group | Role | What they receive |
|---|---|---|
| Condition 1: Tele | Experimental | Intervention for 6 months more or less Receives: Behavioral: Parent Weekly Individual Telephone Support |
| Condition 2: Child Education | Experimental | Intervention for 6 months Receives: Behavioral: Child Education |
| Condition 3: Parent Counseling | Experimental | Intervention for 6 months Receives: Behavioral: Parent Initial Counseling |
| Condition 4: Counseling, Child Education, and Tele | Experimental | Intervention for 6 months Receives: Behavioral: Parent Weekly Individual Telephone Support; Behavioral: Child Education; Behavioral: Parent Initial Counseling |
| Condition 5: Group Support | Experimental | Intervention for 6 months Receives: Behavioral: Parent Monthly Group Support |
| Condition 6: Group Support, Child Education, and Tele | Experimental | Intervention for 6 months Receives: Behavioral: Parent Weekly Individual Telephone Support; Behavioral: Child Education; Behavioral: Parent Monthly Group Support |
| Condition 7: Group Support, Parent Counseling, and Tele | Experimental | Intervention for 6 months Receives: Behavioral: Parent Weekly Individual Telephone Support; Behavioral: Parent Initial Counseling; Behavioral: Parent Monthly Group Support |
| Condition 8: Group Support, Parent Counseling, and Child Education | Experimental | Intervention for 6 months Receives: Behavioral: Child Education; Behavioral: Parent Initial Counseling; Behavioral: Parent Monthly Group Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start22 Aug 2025
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,319 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Leng, MD, MPH, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144800
- Sponsor's protocol ID
- 25-003
- Status last verified
- Oct 2026
- First submitted
- 25 Aug 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Leng J, Gonzalez-Sarinana LI, Minaya S, Narang B, Gilliland J, Gany F. Finding Balance: Insights from Mexican Heritage Families on Living a Healthy Lifestyle in New York City. J Community Health. 2026 Jul 23. doi: 10.1007/s10900-026-01607-5. Online ahead of print.
PubMed 42493744
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family COMIDA (Consumo de Opciones Más Ideales De Alimentos) (Eating More Ideal Food Options)
- ClinicalTrials.gov ID
- NCT07144800
- Acronym / sponsor ID
- 25-003
- Conditions
- Obesity, Child Obesity, Weight Loss
- Keywords
- child obesity, obesity, weight loss, Memorial Sloan Kettering Cancer Center, 25-003
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,319 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Jul 2031 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Condition 1: Tele | Experimental | Behavioral: Parent Weekly Individual Telephone SupportIntervention for 6 months more or less |
| Condition 2: Child Education | Experimental | Behavioral: Child EducationIntervention for 6 months |
| Condition 3: Parent Counseling | Experimental | Behavioral: Parent Initial CounselingIntervention for 6 months |
| Condition 4: Counseling, Child Education, and Tele | Experimental | Behavioral: Parent Weekly Individual Telephone Support, Behavioral: Child Education, Behavioral: Parent Initial CounselingIntervention for 6 months |
| Condition 5: Group Support | Experimental | Behavioral: Parent Monthly Group SupportIntervention for 6 months |
| Condition 6: Group Support, Child Education, and Tele | Experimental | Behavioral: Parent Weekly Individual Telephone Support, Behavioral: Child Education, Behavioral: Parent Monthly Group SupportIntervention for 6 months |
| Condition 7: Group Support, Parent Counseling, and Tele | Experimental | Behavioral: Parent Weekly Individual Telephone Support, Behavioral: Parent Initial Counseling, Behavioral: Parent Monthly Group SupportIntervention for 6 months |
| Condition 8: Group Support, Parent Counseling, and Child Education | Experimental | Behavioral: Child Education, Behavioral: Parent Initial Counseling, Behavioral: Parent Monthly Group SupportIntervention for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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)
Key exclusion criteria (25 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent Weekly Individual Telephone SupportAlso: TeleInterventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual | Behavioural | Condition 1: Tele, Condition 4: Counseling, Child Education, and Tele, Condition 6: Group Support, Child Education, and Tele, Condition 7: Group Support, Parent Counseling, and Tele |
| Child Education6 weekly diet/PA education sessions ('Child Education') | Behavioural | Condition 2: Child Education, Condition 4: Counseling, Child Education, and Tele, Condition 6: Group Support, Child Education, and Tele, Condition 8: Group Support, Parent Counseling, and Child Education |
| Parent Initial CounselingAlso: Parent CounselingInterventionists will deliver a 20-30 minute session via videoconference (e.g. Zoom) using the Family COMIDA Intervention Manual | Behavioural | Condition 3: Parent Counseling, Condition 4: Counseling, Child Education, and Tele, Condition 7: Group Support, Parent Counseling, and Tele, Condition 8: Group Support, Parent Counseling, and Child Education |
| Parent Monthly Group SupportAlso: GroupParents will be invited to join a Spanish language (English if preferred) weekly group videoconference (can join by phone if preferred). | Behavioural | Condition 5: Group Support, Condition 6: Group Support, Child Education, and Tele, Condition 7: Group Support, Parent Counseling, and Tele, Condition 8: Group Support, Parent Counseling, and Child Education |
Primary outcome
Percentage weight loss from baseline among participants
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Derived from this study: PubMed 42493744Leng J, Gonzalez-Sarinana LI, Minaya S, Narang B, Gilliland J, Gany F. Finding Balance: Insights from Mexican Heritage Families on Living a Healthy Lifestyle in New York City. J Community Health. 2026 Jul 23. doi: 10.1007/s10900-026-01607-5. Online ahead of print.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Leng, MD, MPH principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Weekly Individual Telephone Support, Child Education and Parent Initial Counseling in people with Obesity and Child Obesity, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Leng, MD, MPH (646-888-8057, lengj@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage weight loss from baseline among participants (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07144800, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.