NCT07478263

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Mar 2026

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

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Study Timeline

Key milestones and dates

Study Progress17%
Mar 2026Jun 2027

First Submitted

Initial submission to the registry

March 10, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

March 31, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

March 10, 2026

Last Update Submit

March 12, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Participant rating of whether the treatment was helpful

    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

    Number of sessions attended out of the 14 treatment sessions

    During the four months/14 sessions of treatment

Study Arms (1)

Regulation of Cues (ROC)

EXPERIMENTAL

ROC includes appetite awareness training and cue-exposure treatment adapted particularly for Latinas with prediabetes.

Behavioral: Regulation of Cues

Interventions

ROC includes appetite awareness training and cue-exposure treatment adapted particularly for Latinas with prediabetes.

Regulation of Cues (ROC)

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Center for Healthy Eating and Activity Research (CHEAR

La Jolla, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Prediabetic StateObesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Regulation of Cues treatment includes appetite awareness training and cue-exposure treatment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 17, 2026

Study Start

March 31, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations