Phase 2 Obesity Trial, Recruiting NCT05770570 Sponsor: Memorial Sloan Kettering Cancer Center Condition: Obesity
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Phase 2 Obesity Trial, Recruiting

NCT05770570
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

This trial has several separate groups, each with different criteria. A person would need to meet the criteria for the specific group they are being considered for.

COMIDA group:

  • People who identify as Mexican American or Mexican
  • People who are seeking services at the Ventanilla de Salud (VDS) of the Mexican Consulate
  • People who prefer to speak Spanish
  • Adults aged 18 or older
  • People whose Body Mass Index (BMI) is 25 or higher (a standard measure of body weight relative to height)
  • People who agree to have conversations audio recorded

SANOS Focus Group:

  • People who identify as Hispanic or Latino
  • People who are seeking services at VDS or VDS Mobile
  • People who prefer to speak Spanish
  • Adults aged 18 or older
  • People whose BMI is 25 or higher
  • People who agree to have conversations audio recorded

SANOS Main Study (RCT):

  • People who identify as Hispanic or Latino
  • People who are seeking services at VDS or VDS Mobile
  • People who prefer to speak Spanish
  • Adults aged 18 or older
  • People whose BMI is 25 or higher
  • People who own a mobile phone that can receive text messages
  • People who agree to have conversations audio recorded

Family COMIDA group:

  • People who identify as Hispanic or Latino
  • People who are seeking services at, or have previously used, VDS of the Mexican Consulate or VDS Mobile
  • People who prefer to speak Spanish
  • Adults aged 18 or older
  • People who have at least one child under 18 living in the same household
  • People who own a mobile phone that can receive text messages and are willing to receive 3 text messages per week for 3 months
  • People who own an internet-connected device (such as a phone or tablet) that can be used for video calls (such as Zoom)

ROADmAP Main Study (RCT):

  • Adults aged 21 or older
  • People who are licensed taxi or for-hire vehicle (FHV) drivers working at least 35 hours per week
  • People who have been driving for at least 6 months
  • People who are seeking services at Health Fairs, or have previously used Health Fair services
  • People who speak English, French, Bengali, or Spanish
  • People whose BMI is 25 or higher (or 23 or higher for people of South Asian background, in line with World Health Organisation and American Diabetes Association guidelines)
  • People who own a mobile phone that can receive text messages
  • People who agree to have conversations audio recorded

ROADmAP Phase 2:

  • Adults aged 21 or older
  • People who either took part in the ROADmAP main study, or who are managers at a taxi garage, Uber, Lyft, or a driver services organisation or union
  • People who agree to have conversations audio recorded

Who may not be able to join:

COMIDA group:

  • People who will not be in the New York City area for the full study period (3–4 months)
  • People who are pregnant, may be pregnant, or are currently breastfeeding
  • People who have a chronic illness such as cancer, kidney disease, or liver disease (note: people with diabetes, lactose intolerance, or high blood pressure may still be considered)
  • People who follow a medically restricted diet (such as a liquid-only diet)
  • People who do not own a phone that can receive text messages, or who are not willing to receive text messages
  • People whose mental health or cognitive condition, in the judgment of the consenting professional, may make it difficult to give informed consent or follow the study procedures
  • People who already have a family member enrolled in the COMIDA study

SANOS Focus Group:

  • People who are pregnant, may be pregnant, or are currently breastfeeding
  • People who report having a chronic illness such as cancer, kidney disease, or liver disease (note: people with high blood pressure or diabetes may still be considered)
  • People who follow a medically restricted diet (such as a liquid-only diet)
  • People who have a household member who has already participated or agreed to participate in the study

SANOS Main Study (RCT):

  • People who are pregnant, may be pregnant, or are currently breastfeeding, for the full study period (6 months)
  • People who report having a chronic illness such as cancer, kidney disease, or liver disease (note: people with high blood pressure or diabetes may still be considered)
  • People who currently follow a medically restricted diet (such as a liquid-only diet)
  • People who have a household member who has already participated or agreed to participate
  • People who have already taken part in this study previously
  • People who will not be in the New York metropolitan area for the full study period (6 months)
  • People who work for or with the Mexican Consulate, whether as an employee, collaborator, or volunteer

Family COMIDA group:

  • People who are pregnant, may be pregnant, or are currently breastfeeding, for the full study period (3 months)
  • People who will not be in the New York metropolitan area for the full study period (3 months)
  • People who have a chronic illness such as cancer, kidney disease, or liver disease (note: people with diabetes, lactose intolerance, or high blood pressure may still be considered)
  • People who follow a medically restricted diet (such as a liquid-only diet)
  • People who already have a family member who participated in the COMIDA or SANOS studies
  • People who have already taken part in this study previously
  • People who work for or with the Mexican Consulate, whether as an employee, collaborator, or volunteer

ROADmAP Main Study (RCT):

  • People who are pregnant, may be pregnant, or are currently breastfeeding, for the full study period (12 months)
  • People who report having a chronic illness such as cancer, kidney disease, or liver disease that may affect their diet (note: people with high blood pressure or diabetes may still be considered)
  • People who currently follow a medically restricted diet (such as a liquid-only diet)
  • People who have a household member who has already participated or agreed to participate
  • People who have already taken part in this study previously
  • People who will not be in the New York metropolitan area for at least 6 months from when they join the study
  • People who are currently taking, or have taken within the last 7 weeks, any medication used to treat obesity or to manage weight — including Ozempic, Wegovy, Mounjaro, Rybelsus, Trulicity, Saxenda, Victoza, Phentermine, Qsymia, Contrave, Plenity, Orlistat (Xenical), or any other GLP-1 receptor agonist or weight-related medication
  • People who have previously had weight loss or bariatric surgery, or who are planning to have such surgery within the next 12 months

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Jennifer Leng, MD, MPH, Memorial Sloan Kettering Cancer Center

Phone: 646-888-8057

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
22 December 2022
Est. completion
26 February 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Difference in participant body weight from baseline to 12 months; Estimate the cost and incremental cost-effectiveness of the obesity intervention components; Feasibility of weight loss intervention for participants measured by the ROAmAP Process Evaluation Questionnaire

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov