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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05856149




Registration number
NCT05856149
Ethics application status
Date submitted
3/05/2023
Date registered
12/05/2023
Date last updated
1/10/2024

Titles & IDs
Public title
Mobile Diabetes Prevention for Hispanics Living in Rural Areas
Scientific title
Diabetes Prevention for Hispanics Residing in Rural Communities: A Mobile Web-Based Approach
Secondary ID [1] 0 0
R44MD014082
Secondary ID [2] 0 0
R44MD014082
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Mobile Diabetes Prevention Program

Experimental: STEPS - Participants will have access to the mobile, web-based diabetes prevention program-- STEPS--for a total of three months or twelve weeks. They will be able to access all program modules and tools during this period.

No intervention: Usual Care - Participants in the Usual Care control group will not receive an intervention.


BEHAVIORAL: Mobile Diabetes Prevention Program
The intervention is a mobile, web-based diabetes prevention program that participants will have access to for a total of 12 weeks. The intervention is a behavioral intervention aimed at increasing the knowledge and skills of participants to reduce type 2 diabetes risk behaviors.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent weight change at intervention completion
Timepoint [1] 0 0
baseline and 3 months 1 week
Primary outcome [2] 0 0
Percent weight change three months post intervention
Timepoint [2] 0 0
baseline and 6 months 1 week
Secondary outcome [1] 0 0
Change in body mass index
Timepoint [1] 0 0
baseline and 3 months 1 week
Secondary outcome [2] 0 0
Change in body mass index
Timepoint [2] 0 0
baseline and 6 months 1 week
Secondary outcome [3] 0 0
Change in Hemoglobin A1C levels
Timepoint [3] 0 0
baseline and 3 months 1 week
Secondary outcome [4] 0 0
Change in Hemoglobin A1C levels
Timepoint [4] 0 0
baseline and 6 months 1 week
Secondary outcome [5] 0 0
Change in Dietary behaviors - Hispanic Dietary Assessment
Timepoint [5] 0 0
baseline and 3 months 1 week
Secondary outcome [6] 0 0
Change in Dietary behaviors - Hispanic Dietary Assessment
Timepoint [6] 0 0
baseline and 6 months 1 week
Secondary outcome [7] 0 0
Change in Diabetes Knowledge Assessment
Timepoint [7] 0 0
baseline and 3 months 1 week
Secondary outcome [8] 0 0
Change in Diabetes Knowledge Assessment
Timepoint [8] 0 0
baseline and 6 months 1 week
Secondary outcome [9] 0 0
Change in Eating Patterns
Timepoint [9] 0 0
baseline and 3 months 1 week
Secondary outcome [10] 0 0
Change in Eating Patterns
Timepoint [10] 0 0
baseline and 6 months 1 week
Secondary outcome [11] 0 0
Change in Subjectively Measured Physical Activity - International Physical Activity Questionnaire (IPAQ)
Timepoint [11] 0 0
baseline and 3 months 1 week
Secondary outcome [12] 0 0
Change in Subjectively Measured Physical Activity - International Physical Activity Questionnaire (IPAQ)
Timepoint [12] 0 0
baseline and 6 months 1 week
Secondary outcome [13] 0 0
Change in Objectively Measured Physical Activity using Fitbits
Timepoint [13] 0 0
baseline and 3 months 1 week
Secondary outcome [14] 0 0
Change in Objectively Measured Physical Activity using Fitbits
Timepoint [14] 0 0
baseline and 6 months 1 week
Secondary outcome [15] 0 0
Change in Self Efficacy - Weight Efficacy Lifestyle and Physical Activity
Timepoint [15] 0 0
baseline and 3 months 1 week
Secondary outcome [16] 0 0
Change in Self Efficacy - Weight Efficacy Lifestyle and Physical Activity
Timepoint [16] 0 0
baseline and 6 months 1 week
Secondary outcome [17] 0 0
Stages of Change
Timepoint [17] 0 0
baseline and 3 months 1 week
Secondary outcome [18] 0 0
Stages of Change
Timepoint [18] 0 0
baseline and 6 months 1 week
Secondary outcome [19] 0 0
Change in Perceived Stress Scale
Timepoint [19] 0 0
baseline and 3 months 1 week
Secondary outcome [20] 0 0
Change in Perceived Stress Scale
Timepoint [20] 0 0
baseline and 6 months 1 week
Secondary outcome [21] 0 0
Change in Interpersonal Support Scale
Timepoint [21] 0 0
baseline and 3 months 1 week
Secondary outcome [22] 0 0
Change in Interpersonal Support Scale
Timepoint [22] 0 0
baseline and 6 months 1 week
Secondary outcome [23] 0 0
Change in Self-Reported Health
Timepoint [23] 0 0
baseline and 3 months 1 week
Secondary outcome [24] 0 0
Change in Self Reported Health
Timepoint [24] 0 0
baseline and 6 months 1 week
Secondary outcome [25] 0 0
Change in Diabetes Diagnosis
Timepoint [25] 0 0
baseline and 3 months 1 week
Secondary outcome [26] 0 0
Change in Diabetes Diagnosis
Timepoint [26] 0 0
baseline and 6 months 1 week
Secondary outcome [27] 0 0
Program Evaluation - Program Satisfaction
Timepoint [27] 0 0
3 months 1 week

Eligibility
Key inclusion criteria
* 18 years and older
* Language fluency in English or Spanish
* Hispanic
* High risk for prediabetes using the CDC's Prediabetic Screener
* Rural county residence
* Not currently pregnant
* Is cleared for physical activity using the PAR-Q and/or doctor's approval
* Currently has a smartphone with internet access
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* <18 years and older
* Not fluent in English or Spanish
* Not Hispanic
* Not at risk for prediabetes using the CDC's Prediabetic Screener
* Not a rural county residence
* Is currently pregnant
* Is not cleared for physical activity using the PAR-Q and/or doctor's approval
* Does not currently have a smartphone with internet access

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
165
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Other
Name
ISA Associates, Inc.
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute on Minority Health and Health Disparities (NIMHD)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Debra M Rios, DrPH
Address 0 0
ISA Associates
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Debra M Rios, DrPH
Address 0 0
Country 0 0
Phone 0 0
7037390880
Fax 0 0
Email 0 0
drios@isagroup.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05856149