T-UP: Engaging Vulnerable Students in Diabetes Prevention

NCT06385015 | Completed

• 1 other identifier: IRB#23-001257
• 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 to: 1) Evaluate the efficacy of adolescents and young adults (AYA)-tailored version of the University of California Diabetes Prevention Program (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); and, 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 randomize participants to the AYA-tailored DPP cohort vs control cohort. Control participants will be offered the opportunity to participate in the AYA-tailored DPP in the following academic year. Participants will be organized into groups within their DPP cohort based on their student status and/or place of residence. The intervention will include 19 sessions (18 in-person and 1 on-demand) covering 24 DPP modules; each session is approximately an hour in length and will be moderated by a lifestyle coach. At the end of each session, intervention participants will receive an email/text with a unique link to a brief REDCap survey to ascertain acceptability of the session. Control group will receive access to materials about study habits, alcohol use, and financial literacy. Control group will receive materials via e-mail for participants to review on their own time and will receive acceptability surveys. A research assistant (RA) will meet with control participants via Zoom to explain the materials. Participants will complete baseline and 9-month follow-up assessments. Participants will complete a 30 minute questionnaire via REDCap 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

Diabetes Mellitus, Type 2; PreDiabetes

Keywords

Prediabetes; Type 2 Diabetes; Diabetes Prevention Program

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.

Behavioral: Tailored DPP Intervention

Control group

NO INTERVENTION

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

Interventions

Tailored DPP Intervention BEHAVIORAL

The intervention includes 19 sessions (18 in-person and 1 on-demand) covering 24 DPP modules; each session is approximately an hour in length and will be moderated by a trained lifestyle coach. Lifestyle coaches are accessible, collaborative, and culturally competent diabetes care and education specialists trained and certified in the CDC's National DPP curriculum to provide effective guidance and support for program participants. Each group will meet regularly during the academic year, with six in-person sessions delivered per 10-week quarter (for each of three quarters) to allow for breaks during final exams and scheduled school recess (e.g., spring break). It will take place on UCLA campus.

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

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State

Condition Hierarchy (Ancestors)

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

Study Officials

• Lauren Wisk, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

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: January 23, 2024
• First Posted: April 25, 2024
• Study Start: October 4, 2023
• Primary Completion: August 31, 2024
• Study Completion: July 10, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

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)