Family Intervention for Chinese Americans With Type 2 Diabetes

NCT ID: NCT04108299

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-21
• Study Completion Date: 2022-07-30

Brief Summary

The goal of this pilot study is to examine the feasibility and acceptability of a family-oriented SMS intervention in 30 Chinese Americans with T2D and their family members. Participants will be randomized to one of 2 arms (n=15 each): 1) wait-list control and 2) SMS intervention. Both groups will continue to receive standard of care treatment for their T2D. The SMS group will receive brief lifestyle counseling videos via SMS links. At the end of the study, the wait-list control group will be provided the opportunity to receive the counseling videos.

Detailed Description

Chinese Americans are one of the fastest growing immigrant groups in the US, who suffer disproportionately high type 2 diabetes (T2D) burden and have poorly controlled T2D. Given the high economic and societal burden of T2D and rapid population growth in Chinese Americans, there is an urgent need for research to develop effective interventions to address T2D burden in this population. Recent evidence suggests the importance of involving and empowering family members in diabetes intervention and calls for family intervention. A mobile health approach such as short message service (SMS) might be a promising way to deliver such family-oriented interventions to the target population given prior studies suggests that Chinese Americans often report challenges to attend in-person lifestyle counseling because of long working hours and lack of sick time from work. A SMS-based intervention provides the flexibility of allowing them to view the intervention at a time and place convenient to them. This study will serve as the first step to explore an alternative approach for managing T2D in this group.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Wait-list Control

Standard of care

Group Type: PLACEBO_COMPARATOR

Wait-list control group

Intervention Type: BEHAVIORAL

For patient participants, they will continue to receive the standard of usual care for their T2D at the CBWCHC during the course of our study. For family/friend participants, they will continue to receive their routine care with their own doctors during the study. At the end of the study, the wait-list control group (both patient and family/friend participants) will be provided the opportunity to receive the counseling videos delivered to them via SMS links.

SMS Intervention

The SMS group will receive brief lifestyle counseling videos via SMS links. At the end of the study, the wait-list control group will be provided the opportunity to receive the counseling videos.

Group Type: EXPERIMENTAL

SMS intervention

Intervention Type: BEHAVIORAL

2-3 SMS-based diabetes videos will be sent to patients each week for 12 weeks (each video within 10 minutes in duration) to both patients and their family members. Patients and their family members will receive the same intervention videos, including basic information about T2D, importance of diabetes self-management at home, behavioral techniques, and family-oriented sessions. BrainShark will be used to determine whether participants view these,videos. For participants who miss 3 consecutive videos, the study team will follow-up with a phone call to identify barriers to watching the video and remind them to review the video.

Interventions

Wait-list control group

For patient participants, they will continue to receive the standard of usual care for their T2D at the CBWCHC during the course of our study. For family/friend participants, they will continue to receive their routine care with their own doctors during the study. At the end of the study, the wait-list control group (both patient and family/friend participants) will be provided the opportunity to receive the counseling videos delivered to them via SMS links.

Intervention Type: BEHAVIORAL

SMS intervention

2-3 SMS-based diabetes videos will be sent to patients each week for 12 weeks (each video within 10 minutes in duration) to both patients and their family members. Patients and their family members will receive the same intervention videos, including basic information about T2D, importance of diabetes self-management at home, behavioral techniques, and family-oriented sessions. BrainShark will be used to determine whether participants view these,videos. For participants who miss 3 consecutive videos, the study team will follow-up with a phone call to identify barriers to watching the video and remind them to review the video.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• self-identify as Chinese or Chinese American;
• be between the ages of 18 and 70,
• self-report a diagnosis of T2D;
• be willing to receive WeChat messages regarding T2D management,
• possess a smartphone or be willing and able to use a study smartphone. If participants have their own smartphones, they are encouraged to use their own phones. For participants who do not have smartphones, the study will provide them
• has a family member or friend be willing to participate in the study to learn about T2D to better support them

• be between 18-70 years old,
• be willing to receive WeChat messages regarding T2D management
• possess a smartphone or be willing and able to use a study smartphone. If participants have their own smartphones, they are encouraged to use their own phones. For participants who do not have smartphones, the study will provide them

Exclusion Criteria

• unable or unwilling to provide informed consent;
• unable to participate meaningfully in the intervention (e.g., uncorrected sight and hearing impairment);
• unwilling to accept randomization assignment;
• pregnant, plans to becomes pregnant in the next 6 months, or who become pregnant during the study, or
• breastfeeding.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lu Hu, PhD

Role: PRINCIPAL_INVESTIGATOR

New York Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

19-01275

Identifier Type: -

Identifier Source: org_study_id