Type 2 DiabetesNCT04737499
Culturally Appropriate Strategies for Chinese Americans With Diabetes (CASCADe)
A study testing CASCADe in people with Type 2 Diabetes, run by Claremont Graduate University at 1 site in United States.
Trial summary
The project aimed to evaluate the implementation process and efficacy of a culturally tailored Diabetes Self-Management and Education (DSME) program with mobile health (mHealth) technology integration, entitled Culturally Appropriate Strategies for Chinese Americans with Diabetes (CASCADe), among Chinese American… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- CASCADe
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2016to 20 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have been diagnosed with Type 2 diabetes
- having been managing diabetes with diet, oral hypoglycemic agents or insulin, or both
- confirmed HbA1c level >=6.5% and <10%
- 21-75 years old
- residents of San Gabriel Valley
- speak and understand of Mandarin
- willing to use the smartphone-based monitoring devices provided by the project.
Who cannot join
- unable or unwilling to give informed consent
- plan to move out of the area within the 1-year participation study period
- are or plan to be pregnant or breastfeeding in the next 12 months
- have a condition that inhibits movement (e.g., unable to walk unaided, or cannot walk 1/4 mile without stopping)
- have major physical disability or condition that prevents them from participating in person.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clarement Graduate University
Claremont, California, 91711
About this study
Official title: Implementation and Evaluation of A Culturally Tailored Diabetes Self-Management Program for Chinese Americans
The project aimed to evaluate the implementation process and efficacy of a culturally tailored Diabetes Self-Management and Education (DSME) program with mobile health (mHealth) technology integration, entitled Culturally Appropriate Strategies for Chinese Americans with Diabetes (CASCADe), among Chinese American adults with Type 2 diabetes.
Read the detailed description
The CASCADe program includes 1) a home visit for training of monitoring devices use, WeChat app and acquiring family support, 2) 8 weekly education sessions with a combined format of group class, games, food demonstration, group exercise, video and discussion, 3) WeChat follow-up on education tips, monitoring data summary, and group discussion. The monitoring system used a smartphone to coordinate cloud data transmission from a set of wireless devices to capture daily monitoring data on physical activity, body weight, blood pressure and blood glucose levels. WeChat app was used to facilitate behavioral self-monitoring by providing daily messages related to diabetes education curriculum, weekly summary reports on monitoring data as well as reinforcement messages and group discussion on readings and monitoring results implication. A single group pre-post-test design was adopted to evaluate changes of primary (HbA1c) and secondary (Self-efficacy, quality of life and stress coping) outcomes assessed at pre and post of intervention. Engagement and adherence in education sessions and self-monitoring system, and satisfaction with the content and delivery of intervention were also evaluated at the end of the study.
- Conditions
- Type 2 Diabetes
- Being tested
- CASCADe
- Keywords
- Chinese Americans, Type 2 Diabetes, mHealth, Diabetes Self-Management and Education
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CASCADeBehavioural
Culturally tailored diabetes self-management and education sessions with mHealth integration
| Study group | Role | What they receive |
|---|---|---|
| CASCADe Intervention | Experimental | Intervention consisted of eight weekly sessions of health education and diabetes management. Topics covered include recognition of diabetes and its complications, risk factors, nutrition knowledge, dietary practices, exercise, behavioral self-monitoring, medication adherence, and stress management. Intervention also included a home visit for training of monitoring devices use, WeChat app and acquiring family support, and weekly WeChat follow-up on education tips, monitoring data summary, and group discussion. The monitoring system used a smartphone to coordinate cloud data transmission from a set of wireless devices to capture daily monitoring data on physical activity, body weight, blood pressure and blood glucose levels. Receives: Behavioral: CASCADe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Concentration of HbA1c
HbA1c was assessed using the testing kit of A1C Now+ with a finger prick of blood by trained data collector.
Measured: Change from baseline HbA1c at 3 months
Secondary outcomes (2)
Change of Score of Self-efficacy
Chinese version of diabetes self-management self-efficacy scale included 20 items with likert-like response scale of 1-5 and minimum score of 20 and maximum score of 100.
Measured: Change from baseline Self-efficacy score at 3 months
Change of Score of Quality of life
Chinese version of diabetes quality of life scale included 15 items with likert-like response scale of 1-5, and minimum score of 15 and maximum score of 75. .
Measured: Change from baseline Quality of life score at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start5 Jul 2016
- Primary completion15 Feb 2018
- Study completion20 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group pre- and post-test design
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claremont Graduate University
- Sponsor type
- University, hospital or other
- Collaborators
- AHMC Health Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737499
- Sponsor's protocol ID
- CGU IRB#2522
- Status last verified
- Jan 2021
- First submitted
- 28 Jan 2021
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified datasets with individual participant data will be provided by the Principal Investigator upon request. All data sharing requests will be reviewed and approved by the Office of Research and Sponsored Programs at Claremont Graduate University and the research investigating team.
Publications
Xie B, Li Y, Hwang WC, Niu Z, Lei X, Yu R, Lai Y, Fong T, Ma Y. A Culturally Tailored Diabetes Self-Management Education Program With Mobile Health Integration for Chinese Americans With Type 2 Diabetes: Development and Pilot Evaluation Study. JMIR Form Res. 2026 Feb 3;10:e77372. doi: 10.2196/77372.
PubMed 41632517
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of A Culturally Tailored Diabetes Self-Management Program for Chinese Americans
- ClinicalTrials.gov ID
- NCT04737499
- Acronym / sponsor ID
- CGU IRB#2522
- Conditions
- Type 2 Diabetes
- Keywords
- Chinese Americans, Type 2 Diabetes, mHealth, Diabetes Self-Management and Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Claremont Graduate UniversityUniversity, hospital or other
- Collaborators
- AHMC Health Foundation
- Study start
- 5 Jul 2016 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 20 Mar 2018 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project aimed to evaluate the implementation process and efficacy of a culturally tailored Diabetes Self-Management and Education (DSME) program with mobile health (mHealth) technology integration, entitled Culturally Appropriate Strategies for Chinese Americans with Diabetes (CASCADe), among Chinese American adults with Type 2 diabetes.
Detailed description
The CASCADe program includes 1) a home visit for training of monitoring devices use, WeChat app and acquiring family support, 2) 8 weekly education sessions with a combined format of group class, games, food demonstration, group exercise, video and discussion, 3) WeChat follow-up on education tips, monitoring data summary, and group discussion. The monitoring system used a smartphone to coordinate cloud data transmission from a set of wireless devices to capture daily monitoring data on physical activity, body weight, blood pressure and blood glucose levels. WeChat app was used to facilitate behavioral self-monitoring by providing daily messages related to diabetes education curriculum, weekly summary reports on monitoring data as well as reinforcement messages and group discussion on readings and monitoring results implication. A single group pre-post-test design was adopted to evaluate changes of primary (HbA1c) and secondary (Self-efficacy, quality of life and stress coping) outcomes assessed at pre and post of intervention. Engagement and adherence in education sessions and self-monitoring system, and satisfaction with the content and delivery of intervention were also evaluated at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group pre- and post-test design
| Arm | Type | Receives |
|---|---|---|
| CASCADe Intervention | Experimental | Behavioral: CASCADeIntervention consisted of eight weekly sessions of health education and diabetes management. Topics covered include recognition of diabetes and its complications, risk factors, nutrition knowledge, dietary practices, exercise, behavioral self-monitoring, medication adherence, and stress management. Intervention also included a home visit for training of monitoring devices use, WeChat app and acquiring family support, and weekly WeChat follow-up on education tips, monitoring data summary, and group discussion. The monitoring system used a smartphone to coordinate cloud data transmission from a set of wireless devices to capture daily monitoring data on physical activity, body weight, blood pressure and blood glucose levels. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- have been diagnosed with Type 2 diabetes
- having been managing diabetes with diet, oral hypoglycemic agents or insulin, or both
- confirmed HbA1c level >=6.5% and <10%
- 21-75 years old
- residents of San Gabriel Valley
Key exclusion criteria (5 listed)
- unable or unwilling to give informed consent
- plan to move out of the area within the 1-year participation study period
- are or plan to be pregnant or breastfeeding in the next 12 months
- have a condition that inhibits movement (e.g., unable to walk unaided, or cannot walk 1/4 mile without stopping)
- have major physical disability or condition that prevents them from participating in person.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CASCADeCulturally tailored diabetes self-management and education sessions with mHealth integration | Behavioural | CASCADe Intervention |
Primary outcome
Change of Concentration of HbA1c
Time frame: Change from baseline HbA1c at 3 months
HbA1c was assessed using the testing kit of A1C Now+ with a finger prick of blood by trained data collector.
2 secondary outcomes
Change of Score of Self-efficacy
Time frame: Change from baseline Self-efficacy score at 3 months
Change of Score of Quality of life
Time frame: Change from baseline Quality of life score at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Derived from this study: PubMed 41632517Xie B, Li Y, Hwang WC, Niu Z, Lei X, Yu R, Lai Y, Fong T, Ma Y. A Culturally Tailored Diabetes Self-Management Education Program With Mobile Health Integration for Chinese Americans With Type 2 Diabetes: Development and Pilot Evaluation Study. JMIR Form Res. 2026 Feb 3;10:e77372. doi: 10.2196/77372.
- Individual participant dataSharing planned: Yes. De-identified datasets with individual participant data will be provided by the Principal Investigator upon request. All data sharing requests will be reviewed and approved by the Office of Research and Sponsored Programs at Claremont Graduate University and the research investigating team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CASCADe in people with Type 2 Diabetes, run by Claremont Graduate University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Concentration of HbA1c (time frame: Change from baseline HbA1c at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04737499, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.