Family Intervention for Chinese Americans With Type 2 Diabetes

NCT04108299 | Completed Results

• 1 other identifier: 19-01275
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Chinese Americans

Outcome Measures

Primary Outcomes (2)

• Percentage of Videos Watched by Participants

  Measure of SMS intervention feasibility.

  Up to Month 6

• Satisfaction Questionnaire Score

  1-item assessment of satisfaction with the SMS intervention. The item is rated on a scale from 0 (not at all satisfied) to 10 (totally satisfied). The total score is the numerical response; higher scores indicate greater satisfaction.

  Month 6

Secondary Outcomes (15)

• Change in HbA1c Level

  Baseline, Month 6

• Change in Body Weight

  Baseline, Month 6

• Change in Diabetes Management Self-Efficacy Scale (DMSES) Score

  Baseline, Month 6

• Change in Summary of Diabetes Self-Care Activities (SDSCA) Score

  Baseline, Month 6

• Change in Diabetes Knowledge Test Scores

  Baseline, Month 6

Study Arms (2)

Wait-list Control

PLACEBO COMPARATOR

Standard of care

Behavioral: Wait-list control group

SMS Intervention

EXPERIMENTAL

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.

Behavioral: SMS intervention

Interventions

Wait-list control group 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.

Wait-list Control

SMS intervention 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.

SMS Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Lu Hu
• Organization: NYU Langone Health

lu.hu@nyulangone.org

646-501-3438

Study Officials

• Lu Hu, PhD

  New York Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 30, 2019
• Study Start: April 21, 2021
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: August 1, 2024
• Results First Posted: August 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Requests should be directed to lu.hu@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)