A Latina-focused program to address nutrition, cravings, and eating patterns to prevent type 2 diabetes
Reducing Obesity and Risk for Type 2 Diabetes in Latinas Using a Novel Behavioral Strategy Addressing Appetitive Traits
NA · University of California, San Diego · NCT07478263
This program will try a culturally adapted 'Regulation of Cues' behavioral approach to help Latinas with prediabetes and obesity lose weight and lower their risk of developing type 2 diabetes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | University of California, San Diego (other) |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT07478263 on ClinicalTrials.gov |
What this trial studies
The trial adapts the Regulation of Cues (ROC) program for adult Hispanic/Latina women with prediabetes and BMI 30–45 to teach skills for recognizing hunger and fullness cues, managing cravings, and changing eating patterns. Participants receive the ROC behavioral intervention in Spanish or English and are monitored for changes in weight and blood sugar (HbA1c) to see whether the program reduces progression to type 2 diabetes. Key exclusions include current type 2 diabetes, pregnancy or lactation, serious medical or psychiatric conditions, and current enrollment in other weight-loss programs. The study is conducted at the UCSD Center for Healthy Eating and Activity Research (CHEAR) in La Jolla.
Who should consider this trial
Good fit: Ideal participants are Hispanic/Latina women ages 18–55 with BMI 30–45 kg/m2 and an HbA1c of 5.7–6.4% who can read English or Spanish and have physician approval.
Not a fit: People with diagnosed type 2 diabetes, current pregnancy or lactation, serious cardiac or psychiatric conditions, active substance use disorder, bulimia, recent psychiatric hospitalization, or those already in weight-loss programs are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could help Latinas with prediabetes lose weight and reduce their chances of developing type 2 diabetes.
How similar studies have performed: Prior research on cue-based programs like Regulation of Cues has shown promising results for reducing overeating and supporting weight loss, but applying ROC specifically to prevent diabetes in Latinas is relatively new.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women who self-identify as Hispanic/Latina, aged 18-55 * BMI 30-45 kg/m2 * Documented diagnosis of prediabetes also confirmed by HBA1c level of 5.7-6.4% * Spanish or English proficiency at a 5th grade level * Physician approval to participate Exclusion Criteria: * Current diagnosis of T2D * Current Pregnancy or lactation or planning to get pregnant within the study duration * Recent history of heart disease, symptoms of angina, stroke, orthopedic problems that would limit activity during the following 6 months, or any other serious medical condition that would make physical activity unsafe * Currently enrolled in weight-loss program or taking medications for weight loss or prediabetes * Current moderate or severe alcohol or substance use disorder, acute suicidal ideation, psychosis, compensatory behaviors, or a diagnosis of bulimia * Hospitalization due to a psychiatric disorder in the past year. * Planning to move from the San Diego area within the next 6 months
Where this trial is running
La Jolla, California
- UCSD Center for Healthy Eating and Activity Research (CHEAR — La Jolla, California, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prediabetes, Obesity