Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06385015 |
| Other study ID # |
IRB#23-001257 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 4, 2023 |
| Est. completion date |
June 2025 |
Study information
| Verified date |
April 2024 |
| Source |
University of California, Los Angeles |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Aim 1 - Design: Pre/post pilot trial of 100 participants (<1% of total number of eligible
UCLA undergraduates). The investigators will randomize participants to the AYA-tailored DPP
vs control based on a stratified, block (n=2) schema based on age [≤19/≥20] and sex [M/F].
All control participants will be offered the opportunity to participate in the AYA-tailored
DPP in the following academic year (in the interest of equipoise).
Aim 1 - Participant Recruitment: All participants will be asked to complete a brief online
intake form to assess eligibility and to collect preferred contact information. This form
will further allow the investigators to prioritize recruitment efforts of those with
identified food, financial, or stress-related vulnerability (per standard NCHA questions).
After confirming eligibility, a trained research assistant (RA) will reach out to eligible
participants to obtain informed consent and enroll them in the pilot trial.
Aim 1 - Tailored DPP Intervention: Once consented and enrolled, participants will be
randomized into one of two cohorts, the first group will be enrolled in the tailored DPP for
the immediate academic year while the second will be enrolled in a series of unrelated
interventions in year 1 and offered the opportunity to participate in the AYA-tailored DPP
for the following academic year. As social support is a key component of the program,
participants will be organized into groups within their DPP cohort based on their student
status (frosh/soph vs junior/senior) and/or place of residence (residence hall vs
off-campus). 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 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. The Lifestyle Coach's ability to support participants, provide guidance, and
help groups work together effectively is essential for a successful lifestyle change program.
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). The interventions for the intervention
participants will take place on UCLA campus. It will take place at the John Wooden Center,
UCLA Teaching Kitchen, UCLA dining halls, UCLA sculpture garden, UCLA botanical garden, UCLA
Arthur Ashe Student Health & Wellness Center, UCLA Glendon building, UCLA Murphy Hall, and
other UCLA buildings. UC DPP has consistently been using some of these places to facilitate
the program.
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. At the end of each session, participants will receive an email or
text (depending on their preferred method of contact) with a unique link to a brief (~1
minute) REDCap survey to ascertain acceptability of the session. There will be three zoom
sessions in total (one for each intervention).
The last acceptability survey of the Fall and Winter quarter for the intervention group (and
the only acceptability survey for the control group) will ask about self-reported weight and
physical activity. The investigators will send the last acceptability survey of the Fall and
Winter quarter for the intervention group around the same time the investigators will send
the only acceptability survey for the control group.
Aim 1 - Data Collection: Participants will complete two study assessments (baseline and
9-month follow-up).There are two assessments per year, baseline and 9-month follow up for the
first year and baseline and 9-month follow-up for the second year. These assessments will be
done in October and June, respectively. Participants will complete a 30 minute questionnaire
(administered as a Research Electronic Data Capture (REDCap) survey) and height/weight
measurements will be collected using a standardized protocol by a trained research assistant.
RA will meet participants at the Wooden Center to collect measurements. 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.
Aim 1 - Measures: The baseline survey assessment will collect data using validated tools on
sociodemographics (e.g., age, sex, race, ethnicity, socioeconomic status), social
vulnerability (food security using the USDA ERS Food Security 6-Item Short Form, financial
security using the Financial Chronic Stress Scale), health-related quality of life (CDC's
HRQoL tool), mental health (depressive symptoms via Patient Health Questionnaire-8; anxiety
symptoms via Generalized Anxiety Disorder-7), self-perceived weight status (How do you
describe your weight?), and self-reported physical activity and diet (using the International
Physical Activity Questionnaire and Nutrition Screening Survey). Follow-up assessment (at 9
months) will collect data on health-related quality of life, mental health, self-perceived
weight status, and self-reported physical activity and diet. At both time points, height and
weight data will be collected by a trained research assistant.
Aim 2 - Design: Longitudinal analysis of participants of the treatment arm (N=50 in the
AYA-tailored DPP cohort).
Aim 2 - Data Collection: At the end of each session, participants will receive an email or
text (depending on their preferred method of contact) with a unique link to a brief (~1
minute) REDCap survey to ascertain acceptability of the session. Intervention participants
will be asked to complete at least 15 out of the 18 acceptability surveys. The investigators
will implement targeted follow-up reminder schemes via text-messaging and/or e-mail, to
improve participant response rates to these brief interim assessments.
Aim 2 - Measures: To assess feasibility the investigators will determine proportion of
participants who are recruited (enrolled /those completing the initial screen) and retained
(session completion / enrolled). Recruitment source (student health referral vs diffuse
outreach/self-referral) will be compared to determine if characteristics of participants
differed by recruitment source. Acceptability surveys will ask participants to rate
satisfaction with each session on a 5-point Likert scale ("very dissatisfied" to "very
satisfied") with respect to a) content, b) coach, c) group interaction, and d) overall.
Surveys will include an open-ended question to elicit participants' specific
thoughts/perspectives on each session. Retention will be ascertained via attendance taken by
the lifestyle coach.
