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Family Intervention for Chinese Americans With Type 2 Diabetes

NYU Langone Health logo

NYU Langone Health

Status

Completed

Conditions

Type 2 Diabetes

Treatments

Behavioral: SMS intervention
Behavioral: Wait-list control group

Study type

Interventional

Funder types

Other

Identifiers

NCT04108299
19-01275

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

46 participants in 2 patient groups, including a placebo group

Wait-list Control
Placebo Comparator group
Description:
Standard of care
Treatment:
Behavioral: Wait-list control group
SMS Intervention
Experimental group
Description:
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.
Treatment:
Behavioral: SMS intervention

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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