PrediabetesBALANCENCT07478263
Behavioral Approach for Latinas Addressing Nutrition, Cravings, and Eating Patterns to Prevent Type 2 Diabetes
A study testing Regulation of Cues in people with Prediabetes and Obesity (Body Mass Index >30 kg/m2), run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Prediabetes, Obesity (Body Mass Index >30 kg/m2)
- What is being tested?
- Regulation of Cues
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2026to 30 Jun 2027
- 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 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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
UCSD Center for Healthy Eating and Activity Research (CHEAR
La Jolla, California, 92093
Dawn Eichen, PhD, 858-249-1123, deichen@health.ucsd.edu
About this study
Official title: 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.
- Conditions
- Prediabetes, Obesity (Body Mass Index >30 kg/m2)
- Being tested
- Regulation of Cues
- Medical subject headings
- Prediabetic State, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regulation of CuesBehavioural
ROC includes appetite awareness training and cue-exposure treatment adapted particularly for Latinas with prediabetes.
| Study group | Role | What they receive |
|---|---|---|
| Regulation of Cues (ROC) | Experimental | ROC includes appetite awareness training and cue-exposure treatment adapted particularly for Latinas with prediabetes. Receives: Behavioral: Regulation of Cues |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: During the four months/14 sessions of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start31 Mar 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Regulation of Cues treatment includes appetite awareness training and cue-exposure treatment.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Dawn Eichen, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478263
- Sponsor's protocol ID
- 812688
- Other IDs
- P50MD017344
- Acronym
- BALANCE
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Obesity and Risk for Type 2 Diabetes in Latinas Using a Novel Behavioral Strategy Addressing Appetitive Traits
- ClinicalTrials.gov ID
- NCT07478263
- Acronym / sponsor ID
- BALANCE / 812688
- Conditions
- Prediabetes, Obesity (Body Mass Index >30 kg/m2)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 17 Mar 2026 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Regulation of Cues treatment includes appetite awareness training and cue-exposure treatment.
| Arm | Type | Receives |
|---|---|---|
| Regulation of Cues (ROC) | Experimental | Behavioral: Regulation of CuesROC includes appetite awareness training and cue-exposure treatment adapted particularly for Latinas with prediabetes. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Regulation of CuesROC includes appetite awareness training and cue-exposure treatment adapted particularly for Latinas with prediabetes. | Behavioural | Regulation of Cues (ROC) |
Primary outcome
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
Attendance at Treatment Sessions
Time frame: During the four months/14 sessions of treatment
Number of sessions attended out of the 14 treatment sessions
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 17 Mar 2026.
- Individual participant dataSharing planned: No
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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.
UCSD Center for Healthy Eating and Activity Research (CHEAR
La Jolla, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regulation of Cues in people with Prediabetes and Obesity (Body Mass Index >30 kg/m2), run by University of California, San Diego 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 5 inclusion and 7 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 17 Mar 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant rating of whether the treatment was helpful (time frame: Following all 14 treatment sessions ~4 months after the start of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.