New T-UP: Engaging Vulnerable Students in Diabetes Prevention

NCT07225218 | Recruiting

• 1 other identifier: IRB#25-1605
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to enhance reach and uptake of diabetes prevention among young adults, with a focus on recruiting underserved and high-need students who face additional challenges, including food and financial insecurity. The specific aims are: Aim 1 - Evaluate the efficacy of an AYA-tailored version of the UC DPP for mitigating type 2 diabetes risk (i.e., weight change) in a pre/post pilot trial. The investigators hypothesize that the AYA-tailored intervention will be effective at producing 5% weight loss from baseline to program completion (at 9-months). Aim 2 - Assess the feasibility and acceptability of an AYA-tailored version of the UC DPP program. The investigators hypothesize that it will be feasible to recruit the desired number of participants given proposed innovative outreach strategies, and that the AYA-tailored intervention will be deemed acceptable to participants both qualitatively and in regards to their retention in the program at rates similar to the larger UC DPP. The investigators will recruit 80 UCLA undergraduate students. Participants will be asked to complete a brief screening online form to assess eligibility and to collect contact information. The PI and/or Research Assistants (RAs) will reach out to eligible participants to obtain informed consent and enroll them in the pilot trial. The investigators will randomize participants to the tailored DPP cohort vs control cohort. Control participants will be offered the opportunity to participate in the tailored DPP in the following academic year. The tailored DPP intervention will be online and asynchronously. Participants will be asked to complete the intervention lessons on their own time. Each lesson typically takes on average 15 minutes to complete. Control group will receive each intervention materials via e-mail for participants to review on their own time and will receive acceptability surveys. The interventions for the control group will be remote. A research assistant will meet with control participants via Zoom to explain the intervention materials. Control group will receive access to a study habits intervention, alcohol use intervention, and financial literacy intervention. At the end of each quarter (Fall, Winter, and Spring), both control and intervention participants will receive an email with a unique link to a brief REDCap survey to ascertain acceptability of sessions/lessons. Furthermore, participants will complete baseline and 9-month follow-up assessments. Participants will complete a 30 minute questionnaire and height/weight measurements will be collected by a RA. Participants will be asked to self-report weight and physical activity at the end of the fall and winter quarter; data will be collected via brief REDCap survey.

Conditions

Prediabetes; Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Change in weight (pounds, lbs) between baseline and 9-month follow-up

  A physical scale will be used to assess the percent weight (in pounds) at baseline and at 9-months follow-up; change in these two measures will be calculated and used as the primary outcome. The investigators are comparing the percentage change between participants' final weight (in pounds) measurement versus baseline weight (in pounds) measurement as a fraction of participants' baseline weight measurement (= (final - baseline) / baseline)).

  9 months

• Change in self-reported quality of life (Centers for Disease Control and Prevention Health-Related Quality of Life-14 item (CDC HRQOL-14)) between baseline and 9-month follow-up

  A self-reported questionnaire will be administered at baseline and 9-month follow-up and will include questions from the three different modules of the CDC HRQOL-14. The summary "unhealthy days" index, which ranges from 0-30 unhealthy days, will be calculated. Higher scores indicate worse health/well-being.

  9 months

Study Arms (2)

Diabetes Prevention Program (DPP) group

EXPERIMENTAL

The DPP group will receive a tailored Diabetes Prevention Program. The DPP group will complete intervention lessons online and asynchronously. Each lesson typically takes on average 15 minutes to complete.

Behavioral: Tailored DPP Intervention

Control group

NO INTERVENTION

The control group will receive access to a study habits intervention (fall), alcohol use intervention (winter), and financial literacy intervention (spring). The control group will receive each intervention materials via e-mail for participants to review on their own time. The interventions for the control group will be remote. A research assistant will meet with control participants via Zoom to explain the intervention materials. The Zoom session will take approximately 1 hour.

Interventions

Tailored DPP Intervention BEHAVIORAL

The DPP intervention will be online and asynchronously. Participants will be asked to complete the intervention lessons on their own time. Each lesson typically takes on average 15 minutes to complete.

Diabetes Prevention Program (DPP) group

Eligibility Criteria

• Age: 17 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants who are currently enrolled (either full time or part time) as an undergraduate at UCLA and meet criteria for the T-UP Wellness Program (students who have a BMI of ≥25 (≥23 for those self- identifying as Asian) and either documented prediabetes or identified as high-risk on a CDC questionnaire).

You may not qualify if:

• Participants who are not currently enrolled (either full time or part time) as an undergraduate at UCLA and do not meet criteria for the T-UP Wellness Program.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• American Diabetes Association: collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lauren E Wisk, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren E Wisk, PhD

CONTACT

310-267-5308; lwisk@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 4, 2025
• First Posted: November 6, 2025
• Study Start: October 14, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: November 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data dictionary/codebook and request instructions will be made available 6 months after the completion of data collection and cleaning.
• Access Criteria: A credentialed researcher affiliated at a college, university, medical center/system or other non-profit institution, with a proposed research question that is addressable with the available data, who is willing to agree to cite the original data source and ADA as a funding source for all research products using the data, and who is willing to agree to not attempt to identify any of the participants included in the dataset.

Locations

US (1)