Trial Outcomes & Findings for A Mobile Health Intervention to Reduce Diabetes Disparities in Chinese Americans (NCT NCT03557697)
NCT ID: NCT03557697
Last Updated: 2025-02-19
Results Overview
HbA1c testing results abstracted from medical record.
COMPLETED
NA
60 participants
Baseline, Month 3
2025-02-19
Participant Flow
Participant milestones
| Measure |
Wait-list Control
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
28
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Wait-list Control
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
Baseline Characteristics
A Mobile Health Intervention to Reduce Diabetes Disparities in Chinese Americans
Baseline characteristics by cohort
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.9 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
55.6 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
54.3 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 3HbA1c testing results abstracted from medical record.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Average Plasma Glucose Concentration Measured by Hemoglobin A1c (HbA1c) Levels
|
-0.68 Percentage
Interval -1.14 to -0.22
|
-0.95 Percentage
Interval -1.45 to -0.46
|
PRIMARY outcome
Timeframe: Baseline, Month 6HbA1c testing results abstracted from medical record.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Average Plasma Glucose Concentration Measured by Hemoglobin A1c (HbA1c) Levels
|
-0.82 Percentage
Interval -1.3 to -0.34
|
-1.08 Percentage
Interval -1.58 to -0.58
|
SECONDARY outcome
Timeframe: Baseline, Month 38-item questionnaire asking participants to rate their confidence level in performing specific Type 2 Diabetes self-management behaviors on 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 8-80; higher scores indicate higher levels of confidence in performing self-management behaviors.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Stanford Diabetes Self-Efficacy Scale Score
|
-2.72 score on a scale
Interval -6.93 to 1.5
|
5.76 score on a scale
Interval 1.45 to 10.06
|
SECONDARY outcome
Timeframe: Baseline, Month 68-item questionnaire asking participants to rate their confidence level in performing specific Type 2 Diabetes self-management behaviors on 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 8-80; higher scores indicate higher levels of confidence in performing self-management behaviors.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Stanford Diabetes Self-Efficacy Scale Score
|
0.21 score on a scale
Interval -4.07 to 4.48
|
6.08 score on a scale
Interval 1.72 to 10.44
|
SECONDARY outcome
Timeframe: Baseline, Month 3The SDSCA measures the frequency of diabetes self-care activities over the previous week across five domains of self-care. The General Diet subscale comprises 2 items rated on a scale from 0-7. The total General Diet score is the mean of the item responses and ranges from 0-14, with higher scores indicating better compliance.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Summary of Diabetes Self-Care Activities (SDSCA) - General Diet Score
|
0.43 score on a scale
Interval -0.37 to 1.23
|
2.04 score on a scale
Interval 1.21 to 2.86
|
SECONDARY outcome
Timeframe: Baseline, Month 6The SDSCA measures the frequency of diabetes self-care activities over the previous week across five domains of self-care. The General Diet subscale comprises 2 items rated on a scale from 0-7. The total General Diet score is the mean of the item responses and ranges from 0-14, with higher scores indicating better compliance.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Summary of Diabetes Self-Care Activities (SDSCA) - General Diet Score
|
0.09 score on a scale
Interval -0.72 to 0.91
|
1.74 score on a scale
Interval 0.9 to 2.57
|
SECONDARY outcome
Timeframe: Baseline, Month 3The SDSCA measures the frequency of diabetes self-care activities over the previous week across five domains of self-care. The Specific Diet subscale comprises 2 items rated on a scale from 0-7. The total Specific Diet score is the mean of the item responses and ranges from 0-14, with higher scores indicating better compliance.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Specific Diet Score
|
-0.31 score on a scale
Interval -0.93 to 0.32
|
0.17 score on a scale
Interval -0.47 to 0.81
|
SECONDARY outcome
Timeframe: Baseline, Month 6The SDSCA measures the frequency of diabetes self-care activities over the previous week across five domains of self-care. The Specific Diet subscale comprises 2 items rated on a scale from 0-7. The total Specific Diet score is the mean of the item responses and ranges from 0-14, with higher scores indicating better compliance.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Specific Diet Score
|
0.2 score on a scale
Interval -0.43 to 0.84
|
0.59 score on a scale
Interval -0.06 to 1.24
|
SECONDARY outcome
Timeframe: Baseline, Month 3The SDSCA measures the frequency of diabetes self-care activities over the previous week across five domains of self-care. The Exercise subscale comprises 2 items rated on a scale from 0-7. The total Exercise score is the mean of the item responses and ranges from 0-14, with higher scores indicating better compliance.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Exercise Score
|
0.20 score on a scale
Interval -0.61 to 1.01
|
1.26 score on a scale
Interval 0.43 to 2.1
|
SECONDARY outcome
Timeframe: Baseline, Month 6The SDSCA measures the frequency of diabetes self-care activities over the previous week across five domains of self-care. The Exercise subscale comprises 2 items rated on a scale from 0-7. The total Exercise score is the mean of the item responses and ranges from 0-14, with higher scores indicating better compliance.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Exercise Score
|
0.89 score on a scale
Interval 0.07 to 1.72
|
1.56 score on a scale
Interval 0.71 to 2.4
|
SECONDARY outcome
Timeframe: Baseline, Month 3The SDSCA measures the frequency of diabetes self-care activities over the previous week across five domains of self-care. The Blood-Glucose Testing subscale comprises 2 items rated on a scale from 0-7. The total Blood-Glucose Testing score is the mean of the item responses and ranges from 0-14, with higher scores indicating better compliance.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Blood-Glucose Testing Score
|
-0.70 score on a scale
Interval -1.68 to 0.28
|
0.47 score on a scale
Interval -0.52 to 1.46
|
SECONDARY outcome
Timeframe: Baseline, Month 6The SDSCA measures the frequency of diabetes self-care activities over the previous week across five domains of self-care. The Blood-Glucose Testing subscale comprises 2 items rated on a scale from 0-7. The total Blood-Glucose Testing score is the mean of the item responses and ranges from 0-14, with higher scores indicating better compliance.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Blood-Glucose Testing Score
|
-0.14 score on a scale
Interval -1.13 to 0.86
|
0.10 score on a scale
Interval -0.9 to 1.11
|
SECONDARY outcome
Timeframe: Baseline, Month 3The SDSCA measures the frequency of diabetes self-care activities over the previous week across five domains of self-care. The Foot Care subscale comprises 2 items rated on a scale from 0-7. The total Foot Care score is the mean of the item responses and ranges from 0-14, with higher scores indicating better compliance.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Foot Care Score
|
0.00 score on a scale
Interval -0.63 to 0.63
|
-0.22 score on a scale
Interval -0.88 to 0.44
|
SECONDARY outcome
Timeframe: Baseline, Month 6The SDSCA measures the frequency of diabetes self-care activities over the previous week across five domains of self-care. The Foot Care subscale comprises 2 items rated on a scale from 0-7. The total Foot Care score is the mean of the item responses and ranges from 0-14, with higher scores indicating better compliance.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Foot Care Score
|
-0.17 score on a scale
Interval -0.81 to 0.47
|
0.07 score on a scale
Interval -0.6 to 0.73
|
SECONDARY outcome
Timeframe: Baseline, Month 3The SDSCA measures the frequency of diabetes self-care activities over the previous week across five domains of self-care. The Medication Adherence subscale comprises 3 items rated on a scale from 0-7. The total Medication Adherence score is the mean of the item responses and ranges from 0-21, with higher scores indicating better compliance.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Medication Adherence Score
|
0.06 score on a scale
Interval -0.49 to 0.62
|
-0.03 score on a scale
Interval -0.59 to 0.53
|
SECONDARY outcome
Timeframe: Baseline, Month 6The SDSCA measures the frequency of diabetes self-care activities over the previous week across five domains of self-care. The Medication Adherence subscale comprises 3 items rated on a scale from 0-7. The total Medication Adherence score is the mean of the item responses and ranges from 0-21, with higher scores indicating better compliance.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Medication Adherence Score
|
-0.06 score on a scale
Interval -0.63 to 0.51
|
-0.46 score on a scale
Interval -1.03 to 0.11
|
SECONDARY outcome
Timeframe: Baseline, Month 3The Starting The Conversation Scale contains 6 items and asks respondents about the types of food they consumed in the past 30 days. The Fruit subscale comprises 1 item in which respondents indicate how many cups of fruit, on average, they ate each day in the past 30 days. The total score is estimation of average cups of fruit consumed per day.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Starting The Conversation Scale: Fruits
|
-0.44 Cups/day
Interval -0.74 to -0.13
|
0.15 Cups/day
Interval -0.15 to 0.46
|
SECONDARY outcome
Timeframe: Baseline, Month 6The Starting The Conversation Scale contains 6 items and asks respondents about the types of food they consumed in the past 30 days. The Fruit subscale comprises 1 item in which respondents indicate how many cups of fruits, on average, they ate each day in the past 30 days. The total score is estimation of average cups of fruit consumed per day.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Starting The Conversation Scale: Fruits
|
-0.32 Cups/day
Interval -0.63 to -0.01
|
0.17 Cups/day
Interval -0.14 to 0.48
|
SECONDARY outcome
Timeframe: Baseline, Month 3The Starting The Conversation Scale contains 6 items and asks respondents about the types of food they consumed in the past 30 days. The Vegetables subscale comprises 1 item in which respondents indicate how many cups of vegetables, on average, they ate each day in the past 30 days. The total score is estimation of average cups of vegetables consumed per day.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Starting The Conversation Scale: Vegetables
|
-0.06 Cups/day
Interval -0.49 to 0.37
|
0.22 Cups/day
Interval -0.22 to 0.65
|
SECONDARY outcome
Timeframe: Baseline, Month 6The Starting The Conversation Scale contains 6 items and asks respondents about the types of food they consumed in the past 30 days. The Vegetables subscale comprises 1 item in which respondents indicate how many cups of vegetables, on average, they ate each day in the past 30 days. The total score is estimation of average cups of vegetables consumed per day.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Starting The Conversation Scale: Vegetables
|
0.00 Cups/day
Interval -0.43 to 0.43
|
0.52 Cups/day
Interval 0.07 to 0.96
|
SECONDARY outcome
Timeframe: Baseline, Month 3The Starting The Conversation Scale contains 6 items and asks respondents about the types of food they consumed in the past 30 days. The Refined Grains subscale comprises 1 item in which respondents indicate how many cups of refined grains, on average, they ate each day in the past 30 days. The total score is estimation of average cups of refined grains consumed per day.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Starting The Conversation Scale: Refined Grains
|
-0.20 Cups/day
Interval -0.54 to 0.14
|
-0.59 Cups/day
Interval -0.93 to -0.24
|
SECONDARY outcome
Timeframe: Baseline, Month 6The Starting The Conversation Scale contains 6 items and asks respondents about the types of food they consumed in the past 30 days. The Refined Grains subscale comprises 1 item in which respondents indicate how many cups of refined grains, on average, they ate each day in the past 30 days. The total score is estimation of average cups of refined grains consumed per day.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Starting The Conversation Scale: Refined Grains
|
-0.20 Cups/day
Interval -0.54 to 0.15
|
-0.34 Cups/day
Interval -0.7 to 0.01
|
SECONDARY outcome
Timeframe: Baseline, Month 3The Starting The Conversation Scale contains 6 items and asks respondents about the types of food they consumed in the past 30 days. The Whole Wheat subscale comprises 1 item in which respondents indicate how many cups of whole wheat, on average, they ate each day in the past 30 days. The total score is estimation of average cups of whole wheat consumed per day.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Starting The Conversation Scale: Whole Wheat
|
-0.18 Cups/day
Interval -0.47 to 0.11
|
-0.12 Cups/day
Interval -0.42 to 0.18
|
SECONDARY outcome
Timeframe: Baseline, Month 6The Starting The Conversation Scale contains 6 items and asks respondents about the types of food they consumed in the past 30 days. The Whole Wheat subscale comprises 1 item in which respondents indicate how many cups of whole wheat, on average, they ate each day in the past 30 days. The total score is estimation of average cups of whole wheat consumed per day.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Starting The Conversation Scale: Whole Wheat
|
-0.03 Cups/day
Interval -0.33 to 0.27
|
0.08 Cups/day
Interval -0.23 to 0.38
|
SECONDARY outcome
Timeframe: Baseline, Month 3The Starting The Conversation Scale contains 6 items and asks respondents about the types of food they consumed in the past 30 days. The Sugary Drinks subscale comprises 1 item in which respondents indicate how many cans of sugary drinks, on average, they consumed each day in the past 30 days. The total score is estimation of average cans of sugary drinks consumed per day.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Starting The Conversation Scale: Sugary Drinks
|
-0.10 Cans/day
Interval -0.25 to 0.04
|
-0.16 Cans/day
Interval -0.31 to -0.01
|
SECONDARY outcome
Timeframe: Baseline, Month 6The Starting The Conversation Scale contains 6 items and asks respondents about the types of food they consumed in the past 30 days. The Sugary Drinks subscale comprises 1 item in which respondents indicate how many cans of sugary drinks, on average, they consumed each day in the past 30 days. The total score is estimation of average cans of sugary drinks consumed per day.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Starting The Conversation Scale: Sugary Drinks
|
-0.01 Cans/day
Interval -0.15 to 0.14
|
-0.1 Cans/day
Interval -0.25 to 0.05
|
SECONDARY outcome
Timeframe: Baseline, Month 3The Starting The Conversation Scale contains 6 items and asks respondents about the types of food they consumed in the past 30 days. The Starchy Foods subscale comprises 1 item in which respondents indicate how many cups of starchy foods, on average, they ate each day in the past 30 days. The total score is estimation of average cups of starchy foods consumed per day.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Starting The Conversation Scale: Starchy Foods
|
-0.07 Cups/day
Interval -0.32 to 0.18
|
-0.24 Cups/day
Interval -0.5 to 0.02
|
SECONDARY outcome
Timeframe: Baseline, Month 6The Starting The Conversation Scale contains 6 items and asks respondents about the types of food they consumed in the past 30 days. The Starchy Foods subscale comprises 1 item in which respondents indicate how many cups of starchy foods, on average, they ate each day in the past 30 days. The total score is estimation of average cups of starchy foods consumed per day.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Starting The Conversation Scale: Starchy Foods
|
-0.1 Cups/day
Interval -0.35 to 0.16
|
-0.33 Cups/day
Interval -0.59 to -0.07
|
SECONDARY outcome
Timeframe: Baseline, Month 37-item self-assessment providing an estimate of the number of minutes per week participants engage in three categories of physical activity: vigorous activity, moderate activity, and walking activity. Results are expressed in metabolic equivalent (MET) minutes per week. MET minutes represent the amount of energy expended carrying out physical activity. Higher scores indicate higher weekly levels of physical activity.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in International Physical Activity Questionnaire (IPAQ) Score
|
25.58 metabolic equivalent (MET) minutes/week
Interval -949.66 to 1000.81
|
-196.14 metabolic equivalent (MET) minutes/week
Interval -1195.91 to 803.64
|
SECONDARY outcome
Timeframe: Baseline, Month 67-item self-assessment providing an estimate of the number of minutes per week participants engage in three categories of physical activity: vigorous activity, moderate activity, and walking activity. Results are expressed in metabolic equivalent (MET) minutes per week. MET minutes represent the amount of energy expended carrying out physical activity. Higher scores indicate higher weekly levels of physical activity.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in International Physical Activity Questionnaire (IPAQ) Score
|
1032.79 metabolic equivalent (MET) minutes/week
Interval 46.2 to 2019.38
|
199.57 metabolic equivalent (MET) minutes/week
Interval -812.43 to 1211.56
|
SECONDARY outcome
Timeframe: Baseline, Month 3Participants rated the importance of five self-care behaviors related to diabetes self-care-following a diabetic diet, exercising, self-monitoring blood glucose, taking medication, and checking their feet. Each behavior was rated on a 5-point Likert scale, where 1 indicated "not important" and 5 indicated "very important." The total score is calculated as the mean of the item responses and ranges from 1-5, with higher scores indicating greater belief in the importance of diabetes self-management.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Belief in Self-Management Score
|
0.21 score on a scale
Interval 0.02 to 0.4
|
0.05 score on a scale
Interval -0.15 to 0.24
|
SECONDARY outcome
Timeframe: Baseline, Month 6Participants rated the importance of five self-care behaviors related to diabetes self-care-following a diabetic diet, exercising, self-monitoring blood glucose, taking medication, and checking their feet. Each behavior was rated on a 5-point Likert scale, where 1 indicated "not important" and 5 indicated "very important." The total score is calculated as the mean of the item responses and ranges from 1-5, with higher scores indicating greater belief in the importance of diabetes self-management.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Belief in Self-Management Score
|
0.21 score on a scale
Interval 0.02 to 0.4
|
0.14 score on a scale
Interval -0.06 to 0.34
|
SECONDARY outcome
Timeframe: Baseline, Month 3This 17-item scale required participants to rate the extent to which each item was problematic for them in the past month, using a 6-point Likert scale ranging from 1 (no problem) to 6 (serious problem). The total score is the mean of the item scores and ranges from 1-6, with higher scores indicating a greater level of distress.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Diabetes Distress Scale Score
|
0.01 score on a scale
Interval -0.18 to 0.2
|
-0.24 score on a scale
Interval -0.44 to -0.04
|
SECONDARY outcome
Timeframe: Baseline, Month 6This 17-item scale required participants to rate the extent to which each item was problematic for them in the past month, using a 6-point Likert scale ranging from 1 (no problem) to 6 (serious problem). The total score is the mean of the item scores and ranges from 1-6, with higher scores indicating a greater level of distress.
Outcome measures
| Measure |
Wait-list Control
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
Standard of Care: At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
|
SMS Intervention
n=30 Participants
3 measurement visits, baseline, 3, and 6 months
SMS Intervention: Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.
|
|---|---|---|
|
Change in Diabetes Distress Scale Score
|
0.06 score on a scale
Interval -0.13 to 0.25
|
-0.37 score on a scale
Interval -0.58 to -0.17
|
Adverse Events
Wait-list Control
SMS Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place