Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
The goal of this Randomized Controlled Trial (RCT) is to test the effectiveness of a mobile, web-based diabetes prevention program for Hispanics living in rural communities. The main question it aims to answer is: Does STEPS, a mobile, web-based diabetes prevention program, reduce the risk of Type II Diabetes in rural Hispanics compared to usual care? Participants will be randomly assigned to receive either the mobile STEPS intervention or usual care for a total of three months. Researchers will compare percentage weight loss, and additional outcome measures in participants of both groups at months three and six post-baseline.
Trial website
https://clinicaltrials.gov/study/NCT05856149
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05856149