NCT04737499

Brief 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 adults with Type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2018

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
Last Updated

February 4, 2021

Status Verified

January 1, 2021

Enrollment Period

1.6 years

First QC Date

January 28, 2021

Last Update Submit

February 2, 2021

Conditions

Type 2 Diabetes

Keywords

Chinese AmericansType 2 DiabetesmHealthDiabetes Self-Management and Education

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from baseline HbA1c at 3 months

Secondary Outcomes (2)

  • Change of Score of Self-efficacy

    Change from baseline Self-efficacy score at 3 months

  • Change of Score of Quality of life

    Change from baseline Quality of life score at 3 months

Study Arms (1)

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.

Behavioral: CASCADe

Interventions

CASCADeBEHAVIORAL

Culturally tailored diabetes self-management and education sessions with mHealth integration

CASCADe Intervention

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%
  • years old
  • residents of San Gabriel Valley
  • speak and understand of Mandarin
  • willing to use the smartphone-based monitoring devices provided by the project.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clarement Graduate University

Claremont, California, 91711, United States

Location

Related Publications (1)

  • 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.

    PMID: 41632517DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single group pre- and post-test design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2021

First Posted

February 4, 2021

Study Start

July 5, 2016

Primary Completion

February 15, 2018

Study Completion

March 20, 2018

Last Updated

February 4, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

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.

Locations

US(1)