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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| Wait-list Control | Placebo comparator | Standard of care Receives: 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. Receives: Behavioral: SMS intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Videos Watched by Participants
Measure of SMS intervention feasibility.
Measured: 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.
Measured: Month 6
Secondary outcomes (15)
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
Change in Body Weight
Body weight in pounds (lbs).
Measured: Baseline, Month 6
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted30 Sep 2019
- Study start21 Apr 2021
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lu Hu, PhD, Principal investigator, New York Langone Health
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Family-oriented mHealth Intervention for Chinese Americans With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04108299
- Acronym / sponsor ID
- 19-01275
- Conditions
- Type 2 Diabetes
- Keywords
- Chinese Americans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 30 Sep 2019 (actual)
- Results
- Posted 1 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait-list Control | Placebo comparator | Behavioral: Wait-list control groupStandard of care |
| SMS Intervention | Experimental | Behavioral: SMS interventionThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wait-list control groupFor 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. | Behavioural | Wait-list Control |
| SMS intervention2-3 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. | Behavioural | SMS Intervention |
Primary outcome
Percentage of Videos Watched by Participants
Time frame: Up to Month 6
Measure of SMS intervention feasibility.
Satisfaction Questionnaire Score
Time frame: 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.
15 secondary outcomes
Change in HbA1c Level
Time frame: Baseline, Month 6
Change in Body Weight
Time frame: Baseline, Month 6
Change in Diabetes Management Self-Efficacy Scale (DMSES) Score
Time frame: Baseline, Month 6
Change in Summary of Diabetes Self-Care Activities (SDSCA) Score
Time frame: Baseline, Month 6
Change in Diabetes Knowledge Test Scores
Time frame: Baseline, Month 6
Change in International Physical Activity Questionnaire (IPAQ)-Short Version MET Score
Time frame: Baseline, Month 6
Change in Mediterranean Dietary Screener (MEDAS) - Fruit Score
Time frame: Baseline, Month 6
Change in Mediterranean Dietary Screener (MEDAS) - Vegetable Score
Time frame: Baseline, Month 6
Change in Mediterranean Dietary Screener (MEDAS) - Refined Grains Score
Time frame: Baseline, Month 6
Change in Mediterranean Dietary Screener (MEDAS) - Whole Wheat Score
Time frame: Baseline, Month 6
Change in Mediterranean Dietary Screener (MEDAS) - Sugary Drinks Score
Time frame: Baseline, Month 6
Change in Mediterranean Dietary Screener (MEDAS) - Starchy Score
Time frame: Baseline, Month 6
Change in Diabetes-Specific Support Score
Time frame: Baseline, Month 6
Change in the Patient Reported Outcome Measurement Information System (PROMIS) Emotional Support Short Form v2.0 Score
Time frame: Baseline, Month 6
Change in Diabetes Distress Scale Score
Time frame: Baseline, Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lu Hu, PhD principal investigator
New York Langone Health
1 site in 1 country: see every site and its status.
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.