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Type 2 DiabetesNCT04108299

Family Intervention for Chinese Americans With Type 2 Diabetes

A study testing SMS intervention in people with Type 2 Diabetes, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes
What is being tested?
SMS intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
46 participants
Where
1 siteUnited States
Study dates
21 Apr 2021to 30 Jul 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • NYU Langone Health

    New York, New York, 10016

Other trials in United States

About this study

Official title: Feasibility of a Family-oriented mHealth Intervention for Chinese Americans With Type 2 Diabetes

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.

Read the 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
Being tested
Wait-list control group, SMS intervention
Keywords
Chinese Americans
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wait-list control groupBehavioural

    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 interventionBehavioural

    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.

Study groups in NCT04108299
Study groupRoleWhat they receive
Wait-list ControlPlacebo comparatorStandard of care
Receives: Behavioral: Wait-list control group
SMS InterventionExperimentalThe 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.
Receives: Behavioral: SMS intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Videos Watched by Participants

    Measure of SMS intervention feasibility.

    Measured: Up to Month 6

  2. 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.

    Measured: Month 6

Secondary outcomes (15)
  1. Change in HbA1c Level

    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.

    Measured: Baseline, Month 6

  2. Change in Body Weight

    Body weight in pounds (lbs).

    Measured: Baseline, Month 6

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

    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.

    Measured: Baseline, Month 6

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

    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.

    Measured: Baseline, Month 6

  5. Change in Diabetes Knowledge Test Scores

    11-item questionnaire assessing diabetes knowledge. The total score is the number of correct responses and ranges from 0-11.

    Measured: Baseline, Month 6

  6. Change in International Physical Activity Questionnaire (IPAQ)-Short Version MET Score

    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.

    Measured: Baseline, Month 6

  7. Change in Mediterranean Dietary Screener (MEDAS) - Fruit Score

    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.

    Measured: Baseline, Month 6

  8. Change in Mediterranean Dietary Screener (MEDAS) - Vegetable Score

    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.

    Measured: Baseline, Month 6

  9. Change in Mediterranean Dietary Screener (MEDAS) - Refined Grains Score

    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.

    Measured: Baseline, Month 6

  10. Change in Mediterranean Dietary Screener (MEDAS) - Whole Wheat Score

    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.

    Measured: Baseline, Month 6

  11. Change in Mediterranean Dietary Screener (MEDAS) - Sugary Drinks Score

    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.

    Measured: Baseline, Month 6

  12. Change in Mediterranean Dietary Screener (MEDAS) - Starchy Score

    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.

    Measured: Baseline, Month 6

  13. Change in Diabetes-Specific Support Score

    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.

    Measured: Baseline, Month 6

  14. Change in the Patient Reported Outcome Measurement Information System (PROMIS) Emotional Support Short Form v2.0 Score

    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.

    Measured: Baseline, Month 6

  15. Change in Diabetes Distress Scale Score

    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.

    Measured: Baseline, Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2019
  2. Study start21 Apr 2021
  3. Primary completion30 Jul 2022
  4. Study completion30 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04108299
Sponsor's protocol ID
19-01275
Status last verified
Feb 2024
First submitted
26 Sep 2019
Last updated
1 Aug 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Questions about this trial

What is this clinical trial studying?

A study testing SMS intervention in people with Type 2 Diabetes, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Videos Watched by Participants (time frame: Up to Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.

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