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Family Intervention for Chinese Americans With Type 2 Diabetes

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04108299
Enrollment
46
Registered
2019-09-30
Start date
2021-04-21
Completion date
2022-07-30
Last updated
2024-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Chinese Americans

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.

Interventions

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.

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.

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Videos Watched by ParticipantsUp to Month 6Measure of SMS intervention feasibility.
Satisfaction Questionnaire ScoreMonth 61-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

MeasureTime frameDescription
Change in Diabetes Management Self-Efficacy Scale (DMSES) ScoreBaseline, Month 6The 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 Summary of Diabetes Self-Care Activities (SDSCA) ScoreBaseline, Month 6The 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 Diabetes Knowledge Test ScoresBaseline, Month 611-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 ScoreBaseline, Month 6The 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) - Fruit ScoreBaseline, Month 6The 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) - Vegetable ScoreBaseline, Month 6The 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 LevelBaseline, Month 6Participants 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 Mediterranean Dietary Screener (MEDAS) - Whole Wheat ScoreBaseline, Month 6The 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) - Sugary Drinks ScoreBaseline, Month 6The 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 ScoreBaseline, Month 6The 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 ScoreBaseline, Month 6Participants 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 the Patient Reported Outcome Measurement Information System (PROMIS) Emotional Support Short Form v2.0 ScoreBaseline, Month 64-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 Diabetes Distress Scale ScoreBaseline, Month 6The 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.
Change in Mediterranean Dietary Screener (MEDAS) - Refined Grains ScoreBaseline, Month 6The 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 Body WeightBaseline, Month 6Body weight in pounds (lbs).

Countries

United States

Participant flow

Participants by arm

ArmCount
Wait-list Control - Patients
Standard of care Wait-list control group: 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.
12
SMS Intervention - Patients
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. SMS intervention: 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.
11
Wait-list Control - Family/Friend
Standard of care Wait-list control group: 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.
12
SMS Intervention - Family/Friend
Standard of care Wait-list control group: 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.
11
Total46

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyNot interested in participating2121

Baseline characteristics

CharacteristicWait-list Control - PatientsTotalSMS Intervention - Family/FriendWait-list Control - Family/FriendSMS Intervention - Patients
Age, Continuous56.92 years
STANDARD_DEVIATION 7.62
55.42 years
STANDARD_DEVIATION 10.31
48.18 years
STANDARD_DEVIATION 11.04
61.7 years
STANDARD_DEVIATION 5.98
55.45 years
STANDARD_DEVIATION 11.45
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants46 Participants11 Participants12 Participants11 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
12 Participants46 Participants11 Participants12 Participants11 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants0 Participants0 Participants
Region of Enrollment
United States
12 participants46 participants11 participants12 participants11 participants
Sex: Female, Male
Female
6 Participants23 Participants7 Participants5 Participants5 Participants
Sex: Female, Male
Male
6 Participants23 Participants4 Participants7 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 120 / 110 / 120 / 11
other
Total, other adverse events
0 / 120 / 110 / 120 / 11
serious
Total, serious adverse events
0 / 120 / 110 / 120 / 11

Outcome results

Primary

Percentage of Videos Watched by Participants

Measure of SMS intervention feasibility.

Time frame: Up to Month 6

Population: Population comprises 10 participants and 10 family members/friends in the SMS Intervention Group. Participants in the Wait-list Control group were not assessed for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
SMS InterventionPercentage of Videos Watched by Participants76.8 Percentage of videos watchedStandard Deviation 7
Primary

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.

Time frame: Month 6

Population: Participants in the Wait-List Control arm were not assessed for this outcome measure.

ArmMeasureValue (MEAN)Dispersion
SMS InterventionSatisfaction Questionnaire Score9.4 score on a scaleStandard Deviation 1
SMS Intervention - Family/FriendSatisfaction Questionnaire Score10 score on a scaleStandard Deviation 0
Secondary

Change in Body Weight

Body weight in pounds (lbs).

Time frame: Baseline, Month 6

ArmMeasureValue (MEAN)
SMS InterventionChange in Body Weight-4.75 lbs
SMS Intervention - Family/FriendChange in Body Weight-11.68 lbs
Wait-list Control - Family/FriendChange in Body Weight-4.88 lbs
SMS Intervention - Family/FriendChange in Body Weight-2.59 lbs
Secondary

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.

Time frame: Baseline, Month 6

Population: Family/friend participants were not assessed for this outcome measure.

ArmMeasureValue (MEAN)
SMS InterventionChange in Diabetes Distress Scale Score-0.67 score on a scale
SMS Intervention - Family/FriendChange in Diabetes Distress Scale Score-0.5 score on a scale
Secondary

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.

Time frame: Baseline, Month 6

Population: Patient participants were not assessed for this outcome measure.

ArmMeasureValue (MEAN)
SMS InterventionChange in Diabetes Knowledge Test Scores0.14 score on a scale
SMS Intervention - Family/FriendChange in Diabetes Knowledge Test Scores0.24 score on a scale
Secondary

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.

Time frame: Baseline, Month 6

Population: Change in DMSES Score was not assessed in family/friend participants.

ArmMeasureValue (MEAN)
SMS InterventionChange in Diabetes Management Self-Efficacy Scale (DMSES) Score0.43 Score on a scale
SMS Intervention - Family/FriendChange in Diabetes Management Self-Efficacy Scale (DMSES) Score0.38 Score on a scale
Secondary

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.

Time frame: Baseline, Month 6

ArmMeasureValue (MEAN)
SMS InterventionChange in Diabetes-Specific Support Score6.92 score on a scale
SMS Intervention - Family/FriendChange in Diabetes-Specific Support Score3.15 score on a scale
Wait-list Control - Family/FriendChange in Diabetes-Specific Support Score9.22 score on a scale
SMS Intervention - Family/FriendChange in Diabetes-Specific Support Score9.12 score on a scale
Secondary

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.

Time frame: Baseline, Month 6

Population: Change in HbA1c level was not assessed in family/friend participants.

ArmMeasureValue (MEAN)
SMS InterventionChange in HbA1c Level-0.88 percentage of glycosylated hemoglobin
SMS Intervention - Family/FriendChange in HbA1c Level-1.23 percentage of glycosylated hemoglobin
Secondary

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.

Time frame: Baseline, Month 6

ArmMeasureValue (MEAN)
SMS InterventionChange in International Physical Activity Questionnaire (IPAQ)-Short Version MET Score1656.37 Metabolic equivalent (MET)
SMS Intervention - Family/FriendChange in International Physical Activity Questionnaire (IPAQ)-Short Version MET Score1076.7 Metabolic equivalent (MET)
Wait-list Control - Family/FriendChange in International Physical Activity Questionnaire (IPAQ)-Short Version MET Score329.71 Metabolic equivalent (MET)
SMS Intervention - Family/FriendChange in International Physical Activity Questionnaire (IPAQ)-Short Version MET Score765.84 Metabolic equivalent (MET)
Secondary

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.

Time frame: Baseline, Month 6

ArmMeasureValue (MEAN)
SMS InterventionChange in Mediterranean Dietary Screener (MEDAS) - Fruit Score0.07 cups
SMS Intervention - Family/FriendChange in Mediterranean Dietary Screener (MEDAS) - Fruit Score0.08 cups
Wait-list Control - Family/FriendChange in Mediterranean Dietary Screener (MEDAS) - Fruit Score1.03 cups
SMS Intervention - Family/FriendChange in Mediterranean Dietary Screener (MEDAS) - Fruit Score-0.18 cups
Secondary

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.

Time frame: Baseline, Month 6

ArmMeasureValue (MEAN)
SMS InterventionChange in Mediterranean Dietary Screener (MEDAS) - Refined Grains Score-0.31 cups
SMS Intervention - Family/FriendChange in Mediterranean Dietary Screener (MEDAS) - Refined Grains Score-0.09 cups
Wait-list Control - Family/FriendChange in Mediterranean Dietary Screener (MEDAS) - Refined Grains Score-0.39 cups
SMS Intervention - Family/FriendChange in Mediterranean Dietary Screener (MEDAS) - Refined Grains Score-0.68 cups
Secondary

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.

Time frame: Baseline, Month 6

ArmMeasureValue (MEAN)
SMS InterventionChange in Mediterranean Dietary Screener (MEDAS) - Starchy Score0 cups
SMS Intervention - Family/FriendChange in Mediterranean Dietary Screener (MEDAS) - Starchy Score-0.07 cups
Wait-list Control - Family/FriendChange in Mediterranean Dietary Screener (MEDAS) - Starchy Score-0.03 cups
SMS Intervention - Family/FriendChange in Mediterranean Dietary Screener (MEDAS) - Starchy Score-0.07 cups
Secondary

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.

Time frame: Baseline, Month 6

ArmMeasureValue (MEAN)
SMS InterventionChange in Mediterranean Dietary Screener (MEDAS) - Sugary Drinks Score-0.22 cups
SMS Intervention - Family/FriendChange in Mediterranean Dietary Screener (MEDAS) - Sugary Drinks Score-0.31 cups
Wait-list Control - Family/FriendChange in Mediterranean Dietary Screener (MEDAS) - Sugary Drinks Score-0.19 cups
SMS Intervention - Family/FriendChange in Mediterranean Dietary Screener (MEDAS) - Sugary Drinks Score-0.23 cups
Secondary

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.

Time frame: Baseline, Month 6

ArmMeasureValue (MEAN)
SMS InterventionChange in Mediterranean Dietary Screener (MEDAS) - Vegetable Score0.57 cups
SMS Intervention - Family/FriendChange in Mediterranean Dietary Screener (MEDAS) - Vegetable Score0.41 cups
Wait-list Control - Family/FriendChange in Mediterranean Dietary Screener (MEDAS) - Vegetable Score1.18 cups
SMS Intervention - Family/FriendChange in Mediterranean Dietary Screener (MEDAS) - Vegetable Score-0.18 cups
Secondary

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.

Time frame: Baseline, Month 6

ArmMeasureValue (MEAN)
SMS InterventionChange in Mediterranean Dietary Screener (MEDAS) - Whole Wheat Score-0.32 cups
SMS Intervention - Family/FriendChange in Mediterranean Dietary Screener (MEDAS) - Whole Wheat Score0.16 cups
Wait-list Control - Family/FriendChange in Mediterranean Dietary Screener (MEDAS) - Whole Wheat Score0.44 cups
SMS Intervention - Family/FriendChange in Mediterranean Dietary Screener (MEDAS) - Whole Wheat Score-0.09 cups
Secondary

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.

Time frame: Baseline, Month 6

Population: Change in SDSCA score was not assessed in family/friend participants.

ArmMeasureValue (MEAN)
SMS InterventionChange in Summary of Diabetes Self-Care Activities (SDSCA) Score7.15 score on a scale
SMS Intervention - Family/FriendChange in Summary of Diabetes Self-Care Activities (SDSCA) Score10.05 score on a scale
Secondary

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.

Time frame: Baseline, Month 6

ArmMeasureValue (MEAN)
SMS InterventionChange in the Patient Reported Outcome Measurement Information System (PROMIS) Emotional Support Short Form v2.0 Score0.64 score on a scale
SMS Intervention - Family/FriendChange in the Patient Reported Outcome Measurement Information System (PROMIS) Emotional Support Short Form v2.0 Score0.63 score on a scale
Wait-list Control - Family/FriendChange in the Patient Reported Outcome Measurement Information System (PROMIS) Emotional Support Short Form v2.0 Score0.7 score on a scale
SMS Intervention - Family/FriendChange in the Patient Reported Outcome Measurement Information System (PROMIS) Emotional Support Short Form v2.0 Score1.2 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026