Behavioral Approach for Latinas Addressing Nutrition, Cravings, and Eating Patterns to Prevent Type 2 Diabetes (BALANCE)

March 12, 2026 updated by: Dawn Eichen, University of California, San Diego

Reducing Obesity and Risk for Type 2 Diabetes in Latinas Using a Novel Behavioral Strategy Addressing Appetitive Traits

Adapt the Regulation of Cues (ROC) treatment program for Latinas to see if it can treat prediabetes and prevent developing of Type 2 Diabetes and reduce weight.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • Recruiting
        • UCSD Center for Healthy Eating and Activity Research (CHEAR
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regulation of Cues (ROC)
ROC includes appetite awareness training and cue-exposure treatment adapted particularly for Latinas with prediabetes.
Behavioral: Regulation of Cues
ROC includes appetite awareness training and cue-exposure treatment adapted particularly for Latinas with prediabetes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant rating of whether the treatment was helpful
Time Frame: Following all 14 treatment sessions ~4 months after the start of treatment
Participants rating of acceptability of the treatment via questionnaire with item on a 5-point likert scale indicating ranked from 1 - strongly disagree to 5 - strongly agree that the treatment was helpful - higher values equal greater acceptability of treatment
Following all 14 treatment sessions ~4 months after the start of treatment
Attendance at Treatment Sessions
Time Frame: During the four months/14 sessions of treatment
Number of sessions attended out of the 14 treatment sessions
During the four months/14 sessions of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 31, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 812688
  • P50MD017344 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe