N/A
Completed N=46
Family Intervention for Chinese Americans With Type 2 Diabetes
Source: ClinicalTrials.gov NCT04108299 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Percentage of Videos Watched by Participants — 76.8 Percentage of videos watched
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Videos Watched by Participants |
76.8 | — |
| PRIMARY Satisfaction Questionnaire Score |
9.4; 10 | — |
| SECONDARY Change in HbA1c Level |
-0.88; -1.23 | — |
| SECONDARY Change in Body Weight |
-4.75; -11.68; -4.88; -2.59 | — |
| SECONDARY Change in Diabetes Management Self-Efficacy Scale (DMSES) Score |
0.43; 0.38 | — |
| SECONDARY Change in Summary of Diabetes Self-Care Activities (SDSCA) Score |
7.15; 10.05 | — |
| SECONDARY Change in Diabetes Knowledge Test Scores |
0.14; 0.24 | — |
| SECONDARY Change in International Physical Activity Questionnaire (IPAQ)-Short Version MET Score |
1656.37; 1076.7; 329.71; 765.84 | — |
| SECONDARY Change in Mediterranean Dietary Screener (MEDAS) - Fruit Score |
0.07; 0.08; 1.03; -0.18 | — |
| SECONDARY Change in Mediterranean Dietary Screener (MEDAS) - Vegetable Score |
0.57; 0.41; 1.18; -0.18 | — |
| SECONDARY Change in Mediterranean Dietary Screener (MEDAS) - Refined Grains Score |
-0.31; -0.09; -0.39; -0.68 | — |
| SECONDARY Change in Mediterranean Dietary Screener (MEDAS) - Whole Wheat Score |
-0.32; 0.16; 0.44; -0.09 | — |
| SECONDARY Change in Mediterranean Dietary Screener (MEDAS) - Sugary Drinks Score |
-0.22; -0.31; -0.19; -0.23 | — |
| SECONDARY Change in Mediterranean Dietary Screener (MEDAS) - Starchy Score |
0; -0.07; -0.03; -0.07 | — |
| SECONDARY Change in Diabetes-Specific Support Score |
6.92; 3.15; 9.22; 9.12 | — |
| SECONDARY Change in the Patient Reported Outcome Measurement Information System (PROMIS) Emotional Support Short Form v2.0 Score |
0.64; 0.63; 0.7; 1.2 | — |
| SECONDARY Change in Diabetes Distress Scale Score |
-0.67; -0.5 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04108299). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.