Clinical trial NCT04108299: Family Intervention for Chinese Americans With Type 2 Diabetes
Official title: Feasibility of a Family-oriented mHealth Intervention for Chinese Americans With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Chinese Americans
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria for patient participants:

* 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

Inclusion criteria for family/friend participants: family/friend participants must

* 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:

Exclusion criteria for both patient and family/friend participants:

* 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.

Primary outcomes:
measure: Percentage of Videos Watched by Participants
timeFrame: Up to Month 6
measure: Satisfaction Questionnaire Score
timeFrame: Month 6
Secondary outcomes:
measure: Change in HbA1c Level
timeFrame: Baseline, Month 6
measure: Change in Body Weight
timeFrame: Baseline, Month 6
measure: Change in Diabetes Management Self-Efficacy Scale (DMSES) Score
timeFrame: Baseline, Month 6
measure: Change in Summary of Diabetes Self-Care Activities (SDSCA) Score
timeFrame: Baseline, Month 6
measure: Change in Diabetes Knowledge Test Scores
timeFrame: Baseline, Month 6
measure: Change in International Physical Activity Questionnaire (IPAQ)-Short Version MET Score
timeFrame: Baseline, Month 6
measure: Change in Mediterranean Dietary Screener (MEDAS) - Fruit Score
timeFrame: Baseline, Month 6
measure: Change in Mediterranean Dietary Screener (MEDAS) - Vegetable Score
timeFrame: Baseline, Month 6
measure: Change in Mediterranean Dietary Screener (MEDAS) - Refined Grains Score
timeFrame: Baseline, Month 6
measure: Change in Mediterranean Dietary Screener (MEDAS) - Whole Wheat Score
timeFrame: Baseline, Month 6
measure: Change in Mediterranean Dietary Screener (MEDAS) - Sugary Drinks Score
timeFrame: Baseline, Month 6
measure: Change in Mediterranean Dietary Screener (MEDAS) - Starchy Score
timeFrame: Baseline, Month 6
measure: Change in Diabetes-Specific Support Score
timeFrame: Baseline, Month 6
measure: Change in the Patient Reported Outcome Measurement Information System (PROMIS) Emotional Support Short Form v2.0 Score
timeFrame: Baseline, Month 6
measure: Change in Diabetes Distress Scale Score
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Health
name: Lu Hu, PhD
role: PRINCIPAL_INVESTIGATOR
References: