Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06385015
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-01-23
Brief Title:
T-UP Engaging Vulnerable Students in Diabetes Prevention
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Targeted Upstream Prevention T-UP Engaging Vulnerable Students in Diabetes Prevention
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie weight change in a prepost 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 andor 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 emailtext 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 heightweight 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
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 ie weight change in a prepost 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 andor 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 emailtext 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 heightweight 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
Detailed Description:
Aim 1 - Design Prepost 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 n2 schema based on age 1920 and sex MF 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 froshsoph vs juniorsenior andor 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 CDCs National DPP curriculum to provide effective guidance and support for program participants The Lifestyle Coachs 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 recesseg 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-upThere 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 heightweight 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 eg 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 CDCs 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 N50 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 andor 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 outreachself-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 thoughtsperspectives on each session Retention will be ascertained via attendance taken by the lifestyle coach
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 froshsoph vs juniorsenior andor 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 CDCs National DPP curriculum to provide effective guidance and support for program participants The Lifestyle Coachs 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 recesseg 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-upThere 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 heightweight 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 eg 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 CDCs 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 N50 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 andor 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 outreachself-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 thoughtsperspectives on each session Retention will be ascertained via attendance taken by the lifestyle coach
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None