Family Intervention for Chinese Americans With Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: SMS intervention; Behavioral: Wait-list control group

• Registration Number: NCT04108299
• Lead Sponsor: NYU Langone Health

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-09-26
• Study First Submitted QC: 2019-09-26
• Study First Posted: 2019-09-30
• Study Start: 2021-04-21
• Primary Completion: 2022-07-30
• Study Completion: 2022-07-30
• Results First Submitted: 2023-06-09
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-15
• Last Update Submitted: 2024-02-15
• Results First Posted: 2024-08-01
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SMS Intervention	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.
Wait-list Control	Wait-list control group	Standard of care

Primary Outcome Measures

Name	Time	Method
Percentage of Videos Watched by Participants	Up to Month 6	Measure of SMS intervention feasibility.
Satisfaction Questionnaire Score	Month 6	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.

Secondary Outcome Measures

Name	Time	Method
Change in Body Weight	Baseline, Month 6	Body weight in pounds (lbs).
Change in Summary of Diabetes Self-Care Activities (SDSCA) Score	Baseline, Month 6	The SDSCA is a 13-item assessment of participants' adherence to diabetes self-management behaviors. This scale consists of 13 items and asks participate to describe their diabetes self-care activities over the past 7 days. The total score is the sum of responses and ranges from 0 to 91; higher scores indicate greater adherence to self-management behaviors. An increase in scores indicates adherence improved during the observational period.
Change in Mediterranean Dietary Screener (MEDAS) - Fruit Score	Baseline, Month 6	The MEDAS contains 6 items and asks respondents about the types of food they consumed in the past 30 days: 1) fruits, 2) vegetables, 3) refined grains, 4) whole wheat, 5) sugary drinks, and 6) starchy foods. For each type of food, respondents estimate the amount (in cups) of the food they have eaten each day over the past 30 days. Higher scores indicate higher consumption of the food group analyzed.
Change in Mediterranean Dietary Screener (MEDAS) - Whole Wheat Score	Baseline, Month 6	The MEDAS contains 6 items and asks respondents about the types of food they consumed in the past 30 days: 1) fruits, 2) vegetables, 3) refined grains, 4) whole wheat, 5) sugary drinks, and 6) starchy foods. For each type of food, respondents estimate the amount (in cups) of the food they have eaten each day over the past 30 days. Higher scores indicate higher consumption of the food group analyzed.
Change in Diabetes Management Self-Efficacy Scale (DMSES) Score	Baseline, Month 6	The DMSES is an 8-item assessment asking participants to rate their confidence level in performing diabetes-specific self-management behaviors, using a 10-point Likert scale ranging from 1 (not at all confident) to 10 (totally confident). The total score is the sum of responses and ranges from 8 to 80; higher scores indicate greater self-efficacy. An increase in scores indicates self-efficacy improved during the observational period.
Change in Mediterranean Dietary Screener (MEDAS) - Refined Grains Score	Baseline, Month 6	The MEDAS contains 6 items and asks respondents about the types of food they consumed in the past 30 days: 1) fruits, 2) vegetables, 3) refined grains, 4) whole wheat, 5) sugary drinks, and 6) starchy foods. For each type of food, respondents estimate the amount (in cups) of the food they have eaten each day over the past 30 days. Higher scores indicate higher consumption of the food group analyzed.
Change in Mediterranean Dietary Screener (MEDAS) - Starchy Score	Baseline, Month 6	The MEDAS contains 6 items and asks respondents about the types of food they consumed in the past 30 days: 1) fruits, 2) vegetables, 3) refined grains, 4) whole wheat, 5) sugary drinks, and 6) starchy foods. For each type of food, respondents estimate the amount (in cups) of the food they have eaten each day over the past 30 days. Higher scores indicate higher consumption of the food group analyzed.
Change in HbA1c Level	Baseline, Month 6	Participants receive HbA1c blood test at their doctors' office every 3-6 months; HbA1c testing results will be abstracted from the medical record at the participant's health care facility.
Change in Diabetes Knowledge Test Scores	Baseline, Month 6	11-item questionnaire assessing diabetes knowledge. The total score is the number of correct responses and ranges from 0-11.
Change in International Physical Activity Questionnaire (IPAQ)-Short Version MET Score	Baseline, Month 6	The IPAQ calculates each participant's metabolic equivalent (MET) score by asking participants the days and minutes exercised in three categories of intensity (vigorous, moderate, and walking) during the previous one week. One metabolic equivalent (MET) is defined as the amount of oxygen consumed while sitting at rest and is equal to 3.5 ml O2 per kg body weight x min. Higher MET scores indicate higher levels of physical activity. An increase in scores indicates physical activity increased during the observational period.
Change in Mediterranean Dietary Screener (MEDAS) - Vegetable Score	Baseline, Month 6	The MEDAS contains 6 items and asks respondents about the types of food they consumed in the past 30 days: 1) fruits, 2) vegetables, 3) refined grains, 4) whole wheat, 5) sugary drinks, and 6) starchy foods. For each type of food, respondents estimate the amount (in cups) of the food they have eaten each day over the past 30 days. Higher scores indicate higher consumption of the food group analyzed.
Change in the Patient Reported Outcome Measurement Information System (PROMIS) Emotional Support Short Form v2.0 Score	Baseline, Month 6	4-item assessment of the availability of others with whom they could talk and feel appreciated. The total score ranges from 4 - 20; higher scores indicate greater support.
Change in Mediterranean Dietary Screener (MEDAS) - Sugary Drinks Score	Baseline, Month 6	The MEDAS contains 6 items and asks respondents about the types of food they consumed in the past 30 days: 1) fruits, 2) vegetables, 3) refined grains, 4) whole wheat, 5) sugary drinks, and 6) starchy foods. For each type of food, respondents estimate the amount (in cups) of the food they have eaten each day over the past 30 days. Higher scores indicate higher consumption of the food group analyzed.
Change in Diabetes-Specific Support Score	Baseline, Month 6	Participants were asked about diabetes-specific support, such as medication taking, healthy diet, physical activity, blood sugar monitoring, stress management, and diabetes management. Higher scores indicate better support. The total score ranges from 4-80; higher scores indicate greater levels of specific.
Change in Diabetes Distress Scale Score	Baseline, Month 6	The Diabetes Distress Scale consists of 17 items and asks respondents to describe the diabetes-related distress experienced within the past month, including emotional distress, physician-related distress, regimen-related distress, and interpersonal distress. The items are scored on a 6- point Likert scale, ranging from 1 (not a problem) to 6 (a very serious problem). The total score is the sum of responses and ranges from 17 to 102, with higher scores indicating higher levels of diabetes distress.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States