Trial Outcomes & Findings for Together Overcoming Diabetes (NCT NCT04734015)
NCT ID: NCT04734015
Last Updated: 2026-06-16
Results Overview
Change in Adult Participant Fasting HbA1c
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
162 participants
Primary outcome timeframe
Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
Results posted on
2026-06-16
Participant Flow
128 adult/youth dyads submitted Interest Forms. 47 adult/youth dyads were excluded: 23 dyads did not meet inclusion criteria, 13 dyads the adult declined to enroll, 11 dyads were unresponsive/unable to contact.
A total of 162 participants (81 adults and 81 youth) were enrolled and randomized after completing the Baseline assessment. 82 participants (41 adults and 41 youth) were assigned to the Intervention group to immediately receive the TOD curriculum while 80 participants (40 adults and 40 youth) were assigned to the Waitlist group and received the intervention after completion of assessment visits (baseline, 3 months, 6 months, 12 months, 18 months, and 24 months).
Participant milestones
| Measure |
Together Overcoming Diabetes (TOD) Curriculum
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Intervention group (Group A): Together Overcoming Diabetes (TOD).
Group A participant dyads will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
|
Waitlist Control
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Waitlist Control group (Group B). Waitlist family dyads will not initially receive the intervention. They will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
Waitlist participant dyads will begin to receive the intervention program (TOD) approximately 24 months (2 years) after enrollment in the RCT.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
80
|
|
Overall Study
Adult Caregivers
|
41
|
40
|
|
Overall Study
Youth
|
41
|
40
|
|
Overall Study
COMPLETED
|
82
|
80
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Youth Sex/Gender: There was missing data for gender for one youth participant at baseline.
Baseline characteristics by cohort
| Measure |
Together Overcoming Diabetes (TOD) Curriculum
n=82 Participants
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Intervention group (Group A): Together Overcoming Diabetes (TOD).
Group A participant dyads will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
|
Waitlist Control
n=80 Participants
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Waitlist Control group (Group B). Waitlist family dyads will not initially receive the intervention. They will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
Waitlist participant dyads will begin to receive the intervention program (TOD) approximately 24 months (2 years) after enrollment in the RCT.
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex/Gender, Customized
Youth gender · Boy
|
17 Participants
n=41 Participants • Youth Sex/Gender: There was missing data for gender for one youth participant at baseline.
|
21 Participants
n=39 Participants • Youth Sex/Gender: There was missing data for gender for one youth participant at baseline.
|
38 Participants
n=80 Participants • Youth Sex/Gender: There was missing data for gender for one youth participant at baseline.
|
|
Age, Continuous
Adults
|
50.28 Years
STANDARD_DEVIATION 11.83 • n=41 Participants • There was missing data for age for one youth participant at baseline; age was not measured after baseline.
|
48.71 Years
STANDARD_DEVIATION 12.22 • n=40 Participants • There was missing data for age for one youth participant at baseline; age was not measured after baseline.
|
49.50 Years
STANDARD_DEVIATION 11.97 • n=81 Participants • There was missing data for age for one youth participant at baseline; age was not measured after baseline.
|
|
Age, Continuous
Youth
|
13.2 Years
STANDARD_DEVIATION 1.7 • n=40 Participants • There was missing data for age for one youth participant at baseline; age was not measured after baseline.
|
13.1 Years
STANDARD_DEVIATION 2.1 • n=40 Participants • There was missing data for age for one youth participant at baseline; age was not measured after baseline.
|
13.2 Years
STANDARD_DEVIATION 2.0 • n=80 Participants • There was missing data for age for one youth participant at baseline; age was not measured after baseline.
|
|
Sex/Gender, Customized
Youth gender · Girl
|
22 Participants
n=41 Participants • Youth Sex/Gender: There was missing data for gender for one youth participant at baseline.
|
18 Participants
n=39 Participants • Youth Sex/Gender: There was missing data for gender for one youth participant at baseline.
|
40 Participants
n=80 Participants • Youth Sex/Gender: There was missing data for gender for one youth participant at baseline.
|
|
Sex/Gender, Customized
Youth gender · Different identity
|
2 Participants
n=41 Participants • Youth Sex/Gender: There was missing data for gender for one youth participant at baseline.
|
0 Participants
n=39 Participants • Youth Sex/Gender: There was missing data for gender for one youth participant at baseline.
|
2 Participants
n=80 Participants • Youth Sex/Gender: There was missing data for gender for one youth participant at baseline.
|
|
Sex: Female, Male
Female
|
31 Participants
n=41 Participants • Adult caregivers
|
32 Participants
n=40 Participants • Adult caregivers
|
63 Participants
n=81 Participants • Adult caregivers
|
|
Sex: Female, Male
Male
|
10 Participants
n=41 Participants • Adult caregivers
|
8 Participants
n=40 Participants • Adult caregivers
|
18 Participants
n=81 Participants • Adult caregivers
|
|
Race (NIH/OMB)
Adults · American Indian or Alaska Native
|
41 Participants
n=41 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
40 Participants
n=40 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
81 Participants
n=81 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
|
Race (NIH/OMB)
Adults · Asian
|
0 Participants
n=41 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
0 Participants
n=40 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
0 Participants
n=81 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
|
Race (NIH/OMB)
Adults · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
0 Participants
n=40 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
0 Participants
n=81 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
|
Race (NIH/OMB)
Adults · Black or African American
|
0 Participants
n=41 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
0 Participants
n=40 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
0 Participants
n=81 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
|
Race (NIH/OMB)
Adults · White
|
0 Participants
n=41 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
0 Participants
n=40 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
0 Participants
n=81 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
|
Race (NIH/OMB)
Adults · More than one race
|
0 Participants
n=41 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
0 Participants
n=40 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
0 Participants
n=81 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
|
Race (NIH/OMB)
Adults · Unknown or Not Reported
|
0 Participants
n=41 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
0 Participants
n=40 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
0 Participants
n=81 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
|
Race (NIH/OMB)
Youth · American Indian or Alaska Native
|
41 Participants
n=41 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
40 Participants
n=40 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
81 Participants
n=81 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
|
Race (NIH/OMB)
Youth · Asian
|
0 Participants
n=41 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
0 Participants
n=40 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
0 Participants
n=81 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
|
Race (NIH/OMB)
Youth · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
0 Participants
n=40 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
0 Participants
n=81 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
|
Race (NIH/OMB)
Youth · Black or African American
|
0 Participants
n=41 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
0 Participants
n=40 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
0 Participants
n=81 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
|
Race (NIH/OMB)
Youth · White
|
0 Participants
n=41 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
0 Participants
n=40 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
0 Participants
n=81 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
|
Race (NIH/OMB)
Youth · More than one race
|
0 Participants
n=41 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
0 Participants
n=40 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
0 Participants
n=81 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
|
Race (NIH/OMB)
Youth · Unknown or Not Reported
|
0 Participants
n=41 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
0 Participants
n=40 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
0 Participants
n=81 Participants • The overall population numbers are for the full sample of adults and youth. The demographics are separated by adults and youth.
|
|
Adult participant Fasting HbA1c
|
7.67 Percentage Glycated Hemoglobin
STANDARD_DEVIATION 1.90 • n=41 Participants • Adult participants with data collected. HbA1c was not measured for youth.
|
8.20 Percentage Glycated Hemoglobin
STANDARD_DEVIATION 2.07 • n=39 Participants • Adult participants with data collected. HbA1c was not measured for youth.
|
7.93 Percentage Glycated Hemoglobin
STANDARD_DEVIATION 1.99 • n=80 Participants • Adult participants with data collected. HbA1c was not measured for youth.
|
PRIMARY outcome
Timeframe: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24Population: Adult participants with data collected
Change in Adult Participant Fasting HbA1c
Outcome measures
| Measure |
Together Overcoming Diabetes (TOD) Curriculum
n=41 Participants
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Intervention group (Group A): Together Overcoming Diabetes (TOD).
Group A participant dyads will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
|
Waitlist Control
n=39 Participants
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Waitlist Control group (Group B). Waitlist family dyads will not initially receive the intervention. They will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
Waitlist participant dyads will begin to receive the intervention program (TOD) approximately 24 months (2 years) after enrollment in the RCT.
|
|---|---|---|
|
Change in Adult Participant Fasting HbA1c
Month 6
|
7.95 Percentage Glycated Hemoglobin
Standard Deviation 2.11
|
8.01 Percentage Glycated Hemoglobin
Standard Deviation 1.84
|
|
Change in Adult Participant Fasting HbA1c
Month 18
|
7.70 Percentage Glycated Hemoglobin
Standard Deviation 2.28
|
7.41 Percentage Glycated Hemoglobin
Standard Deviation 1.52
|
|
Change in Adult Participant Fasting HbA1c
Baseline (Day 0)
|
7.67 Percentage Glycated Hemoglobin
Standard Deviation 1.90
|
8.20 Percentage Glycated Hemoglobin
Standard Deviation 2.07
|
|
Change in Adult Participant Fasting HbA1c
Month 3
|
7.77 Percentage Glycated Hemoglobin
Standard Deviation 1.55
|
7.94 Percentage Glycated Hemoglobin
Standard Deviation 1.90
|
|
Change in Adult Participant Fasting HbA1c
Month 12
|
8.12 Percentage Glycated Hemoglobin
Standard Deviation 2.00
|
7.92 Percentage Glycated Hemoglobin
Standard Deviation 1.70
|
|
Change in Adult Participant Fasting HbA1c
Month 24
|
7.74 Percentage Glycated Hemoglobin
Standard Deviation 1.89
|
7.94 Percentage Glycated Hemoglobin
Standard Deviation 1.75
|
SECONDARY outcome
Timeframe: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24Population: Adult participants with data collected
BMI change as indication of weight loss
Outcome measures
| Measure |
Together Overcoming Diabetes (TOD) Curriculum
n=41 Participants
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Intervention group (Group A): Together Overcoming Diabetes (TOD).
Group A participant dyads will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
|
Waitlist Control
n=40 Participants
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Waitlist Control group (Group B). Waitlist family dyads will not initially receive the intervention. They will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
Waitlist participant dyads will begin to receive the intervention program (TOD) approximately 24 months (2 years) after enrollment in the RCT.
|
|---|---|---|
|
Change in BMI - Adult Participants
Baseline
|
35.49 kg/m^2
Standard Deviation 8.08
|
37.41 kg/m^2
Standard Deviation 9.59
|
|
Change in BMI - Adult Participants
Month 3
|
35.42 kg/m^2
Standard Deviation 7.11
|
36.76 kg/m^2
Standard Deviation 10.50
|
|
Change in BMI - Adult Participants
Month 6
|
35.78 kg/m^2
Standard Deviation 10.02
|
35.94 kg/m^2
Standard Deviation 9.00
|
|
Change in BMI - Adult Participants
Month 12
|
35.52 kg/m^2
Standard Deviation 6.28
|
36.08 kg/m^2
Standard Deviation 8.41
|
|
Change in BMI - Adult Participants
Month 18
|
36.62 kg/m^2
Standard Deviation 8.75
|
36.60 kg/m^2
Standard Deviation 8.44
|
|
Change in BMI - Adult Participants
Month 24
|
36.25 kg/m^2
Standard Deviation 9.25
|
35.96 kg/m^2
Standard Deviation 7.79
|
SECONDARY outcome
Timeframe: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24Population: Youth participants with data collected
z-score of BMI in children and adolescents that indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the population mean, based on age and sex. A lower z-score represents a better outcome (less obesity), with scores between -1.0 and +1.0 indicating normal weight. Numbers greater than -1.0 and +1.0 indicate overweight status.
Outcome measures
| Measure |
Together Overcoming Diabetes (TOD) Curriculum
n=39 Participants
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Intervention group (Group A): Together Overcoming Diabetes (TOD).
Group A participant dyads will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
|
Waitlist Control
n=37 Participants
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Waitlist Control group (Group B). Waitlist family dyads will not initially receive the intervention. They will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
Waitlist participant dyads will begin to receive the intervention program (TOD) approximately 24 months (2 years) after enrollment in the RCT.
|
|---|---|---|
|
Change in zBMI - Youth Participants
Baseline
|
1.90 Z-score
Standard Deviation 0.91
|
1.91 Z-score
Standard Deviation 0.89
|
|
Change in zBMI - Youth Participants
Month 3
|
1.95 Z-score
Standard Deviation 1.01
|
1.78 Z-score
Standard Deviation 1.05
|
|
Change in zBMI - Youth Participants
Month 6
|
1.89 Z-score
Standard Deviation 0.98
|
1.79 Z-score
Standard Deviation 0.90
|
|
Change in zBMI - Youth Participants
Month 12
|
1.81 Z-score
Standard Deviation 0.92
|
1.80 Z-score
Standard Deviation 1.04
|
|
Change in zBMI - Youth Participants
Month 18
|
1.71 Z-score
Standard Deviation 1.00
|
1.82 Z-score
Standard Deviation 0.89
|
|
Change in zBMI - Youth Participants
Month 24
|
1.58 Z-score
Standard Deviation 1.09
|
1.71 Z-score
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24Population: Adult participants with data collected
Patient Health Questionnaire (PHQ-9) Adult and Adolescent versions. Scoring ranges from 0 to 27. Higher total score equates to worse outcome.
Outcome measures
| Measure |
Together Overcoming Diabetes (TOD) Curriculum
n=41 Participants
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Intervention group (Group A): Together Overcoming Diabetes (TOD).
Group A participant dyads will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
|
Waitlist Control
n=39 Participants
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Waitlist Control group (Group B). Waitlist family dyads will not initially receive the intervention. They will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
Waitlist participant dyads will begin to receive the intervention program (TOD) approximately 24 months (2 years) after enrollment in the RCT.
|
|---|---|---|
|
Change in Depression and Depressive Symptoms - Adult Participants
Month 18
|
4.52 Score on a scale
Standard Deviation 3.87
|
5.76 Score on a scale
Standard Deviation 6.61
|
|
Change in Depression and Depressive Symptoms - Adult Participants
Month 24
|
3.04 Score on a scale
Standard Deviation 3.30
|
6.70 Score on a scale
Standard Deviation 7.16
|
|
Change in Depression and Depressive Symptoms - Adult Participants
Baseline
|
5.54 Score on a scale
Standard Deviation 5.54
|
6.26 Score on a scale
Standard Deviation 5.27
|
|
Change in Depression and Depressive Symptoms - Adult Participants
Month 3
|
4.64 Score on a scale
Standard Deviation 4.60
|
4.32 Score on a scale
Standard Deviation 5.28
|
|
Change in Depression and Depressive Symptoms - Adult Participants
Month 6
|
4.85 Score on a scale
Standard Deviation 4.66
|
4.86 Score on a scale
Standard Deviation 4.15
|
|
Change in Depression and Depressive Symptoms - Adult Participants
Month 12
|
4.18 Score on a scale
Standard Deviation 4.43
|
7.30 Score on a scale
Standard Deviation 6.44
|
SECONDARY outcome
Timeframe: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24Population: Youth participants with data collected
Patient Health Questionnaire (PHQ-9) Adult and Adolescent versions. Scoring ranges from 0 to 27. Higher total score equates to worse outcome.
Outcome measures
| Measure |
Together Overcoming Diabetes (TOD) Curriculum
n=39 Participants
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Intervention group (Group A): Together Overcoming Diabetes (TOD).
Group A participant dyads will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
|
Waitlist Control
n=36 Participants
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Waitlist Control group (Group B). Waitlist family dyads will not initially receive the intervention. They will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
Waitlist participant dyads will begin to receive the intervention program (TOD) approximately 24 months (2 years) after enrollment in the RCT.
|
|---|---|---|
|
Change in Depression and Depressive Symptoms - Youth Participants
Month 12
|
6.64 Score on a scale
Standard Deviation 5.67
|
7.54 Score on a scale
Standard Deviation 6.14
|
|
Change in Depression and Depressive Symptoms - Youth Participants
Month 18
|
7.05 Score on a scale
Standard Deviation 6.49
|
8.33 Score on a scale
Standard Deviation 7.23
|
|
Change in Depression and Depressive Symptoms - Youth Participants
Month 24
|
6.00 Score on a scale
Standard Deviation 5.00
|
7.19 Score on a scale
Standard Deviation 5.99
|
|
Change in Depression and Depressive Symptoms - Youth Participants
Baseline
|
6.21 Score on a scale
Standard Deviation 4.29
|
8.08 Score on a scale
Standard Deviation 6.24
|
|
Change in Depression and Depressive Symptoms - Youth Participants
Month 6
|
5.77 Score on a scale
Standard Deviation 3.88
|
7.22 Score on a scale
Standard Deviation 5.56
|
|
Change in Depression and Depressive Symptoms - Youth Participants
Month 3
|
6.35 Score on a scale
Standard Deviation 5.87
|
6.75 Score on a scale
Standard Deviation 5.36
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0, Month 6, Month 12, and Month 24Population: Adult participants with data collected
Number of days of physical activity per week
Outcome measures
| Measure |
Together Overcoming Diabetes (TOD) Curriculum
n=41 Participants
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Intervention group (Group A): Together Overcoming Diabetes (TOD).
Group A participant dyads will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
|
Waitlist Control
n=38 Participants
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Waitlist Control group (Group B). Waitlist family dyads will not initially receive the intervention. They will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
Waitlist participant dyads will begin to receive the intervention program (TOD) approximately 24 months (2 years) after enrollment in the RCT.
|
|---|---|---|
|
Change in Physical Activity - Adult Participants
Baseline
|
2.17 Days per week
Standard Deviation 2.05
|
0.87 Days per week
Standard Deviation 1.80
|
|
Change in Physical Activity - Adult Participants
Month 6
|
1.77 Days per week
Standard Deviation 2.39
|
2.32 Days per week
Standard Deviation 2.58
|
|
Change in Physical Activity - Adult Participants
Month 12
|
1.73 Days per week
Standard Deviation 2.03
|
1.81 Days per week
Standard Deviation 2.29
|
|
Change in Physical Activity - Adult Participants
Month 24
|
2.13 Days per week
Standard Deviation 2.49
|
1.36 Days per week
Standard Deviation 1.92
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0, Month 6, Month 12, and Month 24Population: Youth participants with data collected
Number of days of physical activity per week
Outcome measures
| Measure |
Together Overcoming Diabetes (TOD) Curriculum
n=41 Participants
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Intervention group (Group A): Together Overcoming Diabetes (TOD).
Group A participant dyads will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
|
Waitlist Control
n=39 Participants
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Waitlist Control group (Group B). Waitlist family dyads will not initially receive the intervention. They will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
Waitlist participant dyads will begin to receive the intervention program (TOD) approximately 24 months (2 years) after enrollment in the RCT.
|
|---|---|---|
|
Change in Physical Activity - Youth Participants
Baseline
|
3.12 Days per week
Standard Deviation 2.52
|
3.02 Days per week
Standard Deviation 2.44
|
|
Change in Physical Activity - Youth Participants
Month 6
|
2.85 Days per week
Standard Deviation 2.29
|
2.73 Days per week
Standard Deviation 1.73
|
|
Change in Physical Activity - Youth Participants
Month 12
|
3.00 Days per week
Standard Deviation 2.60
|
2.54 Days per week
Standard Deviation 2.04
|
|
Change in Physical Activity - Youth Participants
Month 24
|
2.92 Days per week
Standard Deviation 2.50
|
2.30 Days per week
Standard Deviation 2.28
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0, Month 6, Month 12, and Month 24Population: Adult participants with data collected
Communal Mastery as a Coping Resource. Scoring ranges from 0 to 18. Higher score equates to better outcome.
Outcome measures
| Measure |
Together Overcoming Diabetes (TOD) Curriculum
n=40 Participants
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Intervention group (Group A): Together Overcoming Diabetes (TOD).
Group A participant dyads will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
|
Waitlist Control
n=39 Participants
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Waitlist Control group (Group B). Waitlist family dyads will not initially receive the intervention. They will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
Waitlist participant dyads will begin to receive the intervention program (TOD) approximately 24 months (2 years) after enrollment in the RCT.
|
|---|---|---|
|
Change in Communal Mastery - Adult Participants
Baseline
|
13.65 Score on a scale
Standard Deviation 2.46
|
13.26 Score on a scale
Standard Deviation 2.86
|
|
Change in Communal Mastery - Adult Participants
Month 6
|
13.77 Score on a scale
Standard Deviation 2.70
|
12.54 Score on a scale
Standard Deviation 3.08
|
|
Change in Communal Mastery - Adult Participants
Month 12
|
13.50 Score on a scale
Standard Deviation 3.13
|
12.56 Score on a scale
Standard Deviation 2.24
|
|
Change in Communal Mastery - Adult Participants
Month 24
|
14.32 Score on a scale
Standard Deviation 3.13
|
13.09 Score on a scale
Standard Deviation 2.50
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0, Month 6, Month 12, and Month 24Population: Youth participants with data collected
Communal Mastery as a Coping Resource. Scoring ranges from 0 to 18. Higher score equates to better outcome.
Outcome measures
| Measure |
Together Overcoming Diabetes (TOD) Curriculum
n=40 Participants
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Intervention group (Group A): Together Overcoming Diabetes (TOD).
Group A participant dyads will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
|
Waitlist Control
n=39 Participants
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Waitlist Control group (Group B). Waitlist family dyads will not initially receive the intervention. They will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
Waitlist participant dyads will begin to receive the intervention program (TOD) approximately 24 months (2 years) after enrollment in the RCT.
|
|---|---|---|
|
Change in Communal Mastery - Youth Participants
Month 24
|
12.79 Score on a scale
Standard Deviation 2.55
|
12.27 Score on a scale
Standard Deviation 2.55
|
|
Change in Communal Mastery - Youth Participants
Baseline
|
12.45 Score on a scale
Standard Deviation 2.64
|
12.56 Score on a scale
Standard Deviation 2.78
|
|
Change in Communal Mastery - Youth Participants
Month 6
|
13.08 Score on a scale
Standard Deviation 2.57
|
12.35 Score on a scale
Standard Deviation 2.25
|
|
Change in Communal Mastery - Youth Participants
Month 12
|
12.91 Score on a scale
Standard Deviation 2.07
|
12.50 Score on a scale
Standard Deviation 2.28
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0, Month 6, Month 12, and Month 24Population: Adult participants with data collected
Diabetes Empowerment Scale. Scoring ranges from 0 to 24. Higher score equates to better outcome.
Outcome measures
| Measure |
Together Overcoming Diabetes (TOD) Curriculum
n=38 Participants
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Intervention group (Group A): Together Overcoming Diabetes (TOD).
Group A participant dyads will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
|
Waitlist Control
n=38 Participants
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth) randomly assigned to the Waitlist Control group (Group B). Waitlist family dyads will not initially receive the intervention. They will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
Waitlist participant dyads will begin to receive the intervention program (TOD) approximately 24 months (2 years) after enrollment in the RCT.
|
|---|---|---|
|
Change in Diabetes Empowerment - Adult Participants
Baseline
|
17.11 Score on a scale
Standard Deviation 2.65
|
16.42 Score on a scale
Standard Deviation 3.23
|
|
Change in Diabetes Empowerment - Adult Participants
Month 6
|
17.42 Score on a scale
Standard Deviation 2.97
|
16.68 Score on a scale
Standard Deviation 3.23
|
|
Change in Diabetes Empowerment - Adult Participants
Month 12
|
17.55 Score on a scale
Standard Deviation 2.86
|
16.56 Score on a scale
Standard Deviation 2.76
|
|
Change in Diabetes Empowerment - Adult Participants
Month 24
|
18.16 Score on a scale
Standard Deviation 3.20
|
16.18 Score on a scale
Standard Deviation 2.27
|
Adverse Events
Together Overcoming Diabetes (TOD) Curriculum - ADULTS
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Together Overcoming Diabetes (TOD) Curriculum - YOUTH
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Control - ADULTS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Control - YOUTH
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Together Overcoming Diabetes (TOD) Curriculum - ADULTS
n=41 participants at risk
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth).
41 adults were randomly assigned to the Intervention group (Group A): Together Overcoming Diabetes (TOD).
Group A participant dyads will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
|
Together Overcoming Diabetes (TOD) Curriculum - YOUTH
n=41 participants at risk
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth).
41 youth were randomly assigned to the Intervention group (Group A): Together Overcoming Diabetes (TOD).
Group A participant dyads will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
|
Waitlist Control - ADULTS
n=40 participants at risk
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth).
40 adults were randomly assigned to the Waitlist Control group (Group B).
Waitlist family dyads will not initially receive the intervention. They will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
Waitlist participant dyads will begin to receive the intervention program (TOD) approximately 24 months (2 years) after enrollment in the RCT.
|
Waitlist Control - YOUTH
n=40 participants at risk
A randomized waitlist control trial (RCT) design will be employed with 81 family dyads (adult caregiver and youth).
40 youth were randomly assigned to the Waitlist Control group (Group B).
Waitlist family dyads will not initially receive the intervention. They will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.
Waitlist participant dyads will begin to receive the intervention program (TOD) approximately 24 months (2 years) after enrollment in the RCT.
|
|---|---|---|---|---|
|
General disorders
Participant became ineligible due to progression of memory loss
|
2.4%
1/41 • From enrollment (baseline assessment) up to 24 month assessment
|
0.00%
0/41 • From enrollment (baseline assessment) up to 24 month assessment
|
0.00%
0/40 • From enrollment (baseline assessment) up to 24 month assessment
|
0.00%
0/40 • From enrollment (baseline assessment) up to 24 month assessment
|
Other adverse events
Adverse event data not reported
Additional Information
Melissa Walls, PhD
Johns Hopkins Bloomberg School of Public Health, Center for Indigenous Health
Phone: 218-724-1665
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place