Trial Outcomes & Findings for Iterative Beta Testing of Videos for the DIPPer Academy (NCT NCT03385265)
NCT ID: NCT03385265
Last Updated: 2022-03-11
Results Overview
Measure of hemoglobin A1c (HbA1c).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
absolute value Post-treatment (Week 33)
Results posted on
2022-03-11
Participant Flow
recruited in clinic or by telephone.
pre-assignment all parents completed baseline assessment measures
Participant milestones
| Measure |
DIPPer Academy- Parents
Parents randomized to this group will participate in the DIPPer Academy curriculum via the internet.
|
Standard of Care Control- Parents
Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team.
|
DIPPer Academy- Children
Parents randomized to this group will participate in DIPPer Academy via the internet. We collect Child HbA1c levels. Children do not receive treatment.
|
Standard of Care- Children
Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team. We collect Child HbA1c levels.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
11
|
20
|
11
|
|
Overall Study
COMPLETED
|
15
|
9
|
15
|
9
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
5
|
2
|
Reasons for withdrawal
| Measure |
DIPPer Academy- Parents
Parents randomized to this group will participate in the DIPPer Academy curriculum via the internet.
|
Standard of Care Control- Parents
Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team.
|
DIPPer Academy- Children
Parents randomized to this group will participate in DIPPer Academy via the internet. We collect Child HbA1c levels. Children do not receive treatment.
|
Standard of Care- Children
Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team. We collect Child HbA1c levels.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
5
|
2
|
Baseline Characteristics
Iterative Beta Testing of Videos for the DIPPer Academy
Baseline characteristics by cohort
| Measure |
DIPPer Academy- Parents
n=20 Participants
Parents randomized to this group will participate in the DIPPer Academy curriculum.
DIPPer Academy: The DIPPer Academy curricula will build on treatment models guided by the Health Beliefs Model (HBM) and Social Cognitive Theory (SCT). The curricula includes video microlectures, personalize progress reports, and other features delivered via the internet.
|
Standard of Care Control- Parents
n=11 Participants
Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team.
|
DIPPer Academy- Children
n=20 Participants
Parents randomized to this group will participate in the DIPPer Academy curriculum. We collect children's HbA1c level.
DIPPer Academy: The DIPPer Academy curricula will build on treatment models guided by the Health Beliefs Model (HBM) and Social Cognitive Theory (SCT). The curricula includes video microlectures, personalize progress reports, and other features delivered via the internet. Children do not receive treatment.
|
Standard of Care Control- Children
n=11 Participants
Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team. We collect children's HbA1c level.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
36.25 years
STANDARD_DEVIATION 4.82 • n=5 Participants
|
32.64 years
STANDARD_DEVIATION 5.98 • n=7 Participants
|
4.98 years
STANDARD_DEVIATION .89 • n=5 Participants
|
4.42 years
STANDARD_DEVIATION .89 • n=4 Participants
|
19.87 years
STANDARD_DEVIATION 15.70 • n=21 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: absolute value Post-treatment (Week 33)Population: lost to follow-up n=5 parents in DIPPer group and n=2 parents in standard care at 33 weeks; parents withdrew themselves
Measure of hemoglobin A1c (HbA1c).
Outcome measures
| Measure |
DIPPer Academy
n=15 Participants
Parents randomized to this group will participate in the DIPPer Academy curriculum.
DIPPer Academy: The DIPPer Academy curricula will build on treatment models guided by the Health Beliefs Model (HBM) and Social Cognitive Theory (SCT). The curricula includes video microlectures, personalize progress reports, and other features delivered via the internet.
|
Standard of Care Control
n=9 Participants
Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team.
|
|---|---|---|
|
Child Glycemic Control
|
7.56 percentage of glycated hemoglobin cells
Standard Deviation 1.17
|
8.14 percentage of glycated hemoglobin cells
Standard Deviation 0.73
|
PRIMARY outcome
Timeframe: absolute value Post-treatment (Week 33)Population: lost to follow-up n=5 parents in DIPPer group and n=2 parents in standard care at 33 weeks; parents withdrew themselves.
Center for Epidemiological Studies-Depression Scale Revised (CES-D); higher scores suggest worse outcome. Range 0-60.
Outcome measures
| Measure |
DIPPer Academy
n=15 Participants
Parents randomized to this group will participate in the DIPPer Academy curriculum.
DIPPer Academy: The DIPPer Academy curricula will build on treatment models guided by the Health Beliefs Model (HBM) and Social Cognitive Theory (SCT). The curricula includes video microlectures, personalize progress reports, and other features delivered via the internet.
|
Standard of Care Control
n=9 Participants
Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team.
|
|---|---|---|
|
Parent Depressive Symptoms
|
10.0 units on a scale
Standard Deviation 9.35
|
7.33 units on a scale
Standard Deviation 8.28
|
PRIMARY outcome
Timeframe: Absolute value at Post-treatment (Week 33)Population: lost to follow-up n=5 parents in DIPPer group and n=2 parents in standard care at 33 weeks; parents withdrew themselves.
Problem Areas in Diabetes Distress- Parent Report Questionnaire. Higher scores reflect worse outcome. Range 0-72
Outcome measures
| Measure |
DIPPer Academy
n=15 Participants
Parents randomized to this group will participate in the DIPPer Academy curriculum.
DIPPer Academy: The DIPPer Academy curricula will build on treatment models guided by the Health Beliefs Model (HBM) and Social Cognitive Theory (SCT). The curricula includes video microlectures, personalize progress reports, and other features delivered via the internet.
|
Standard of Care Control
n=9 Participants
Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team.
|
|---|---|---|
|
Parent Diabetes Distress
|
29.23 units on a scale
Standard Deviation 18.86
|
27.36 units on a scale
Standard Deviation 10.29
|
SECONDARY outcome
Timeframe: absolute value at Post-treatment (Week 33)Population: lost to follow-up n=5 parents in DIPPer group and n=2 parents in standard care at 33 weeks; parents withdrew themselves.
Behavioral Pediatrics Feeding Assessment Scale. This is a 35 item scale. This subscale reflects the frequency of perceived mealtime behavior problems (possible range: 35-175). Higher scores represent a worse outcome.
Outcome measures
| Measure |
DIPPer Academy
n=15 Participants
Parents randomized to this group will participate in the DIPPer Academy curriculum.
DIPPer Academy: The DIPPer Academy curricula will build on treatment models guided by the Health Beliefs Model (HBM) and Social Cognitive Theory (SCT). The curricula includes video microlectures, personalize progress reports, and other features delivered via the internet.
|
Standard of Care Control
n=9 Participants
Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team.
|
|---|---|---|
|
Family Mealtime behaviors_Frequency
|
78.23 units on a scale
Standard Deviation 13.81
|
92.67 units on a scale
Standard Deviation 14.93
|
SECONDARY outcome
Timeframe: absolute value at Post-treatment (Week 33)Population: lost to follow-up n=5 parents in DIPPer group and n=2 parents in standard care at 33 weeks; parents withdrew themselves.
Measured using the Hypoglycemia Fear Survey (HFS-PYC). This is a 26 item measure and higher values represent a worse outcome. Range: 26-130.
Outcome measures
| Measure |
DIPPer Academy
n=15 Participants
Parents randomized to this group will participate in the DIPPer Academy curriculum.
DIPPer Academy: The DIPPer Academy curricula will build on treatment models guided by the Health Beliefs Model (HBM) and Social Cognitive Theory (SCT). The curricula includes video microlectures, personalize progress reports, and other features delivered via the internet.
|
Standard of Care Control
n=9 Participants
Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team.
|
|---|---|---|
|
Parents' Hypoglycemia Fear
|
71.08 units on a scale
Standard Deviation 15.96
|
64.00 units on a scale
Standard Deviation 12.75
|
SECONDARY outcome
Timeframe: Absolute value at Post-treatment (Week 33)Population: lost to follow-up n=5 families in DIPPer group and n=2 families in standard care at 33 weeks; families withdrew themselves.
Measured using the Pediatric Inventory for Parents. This is a 42 item measure. Measure is scored so that higher values represent a worse outcome. Range: 42-210
Outcome measures
| Measure |
DIPPer Academy
n=15 Participants
Parents randomized to this group will participate in the DIPPer Academy curriculum.
DIPPer Academy: The DIPPer Academy curricula will build on treatment models guided by the Health Beliefs Model (HBM) and Social Cognitive Theory (SCT). The curricula includes video microlectures, personalize progress reports, and other features delivered via the internet.
|
Standard of Care Control
n=9 Participants
Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team.
|
|---|---|---|
|
Parenting Stress- Frequency
|
95.77 units on a scale
Standard Deviation 32.78
|
90.44 units on a scale
Standard Deviation 27.55
|
SECONDARY outcome
Timeframe: Absolute value at Post-treatment (Week 33)Population: lost to follow-up n=5 parents in DIPPer group and n=2 parents in standard care at 33 weeks; parents withdrew themselves.
Measured using the Parental Self-Efficacy Scale for Diabetes Management. This is an 8 item measure of self-efficacy. It has only a total score (items are summed for the total). Range 8-40. Higher scores represent a better outcome.
Outcome measures
| Measure |
DIPPer Academy
n=15 Participants
Parents randomized to this group will participate in the DIPPer Academy curriculum.
DIPPer Academy: The DIPPer Academy curricula will build on treatment models guided by the Health Beliefs Model (HBM) and Social Cognitive Theory (SCT). The curricula includes video microlectures, personalize progress reports, and other features delivered via the internet.
|
Standard of Care Control
n=9 Participants
Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team.
|
|---|---|---|
|
Parents' T1D Self-efficacy
|
34.62 units on a scale
Standard Deviation 3.91
|
33.67 units on a scale
Standard Deviation 3.54
|
SECONDARY outcome
Timeframe: Absolute value at Post-treatment (Week 33)Population: lost to follow-up n=5 parents in DIPPer group and n=2 parents in standard care at 33 weeks; parents withdrew themselves.
Test of Diabetes Knowledge-5. This is a 41 item measure. There is general knowledge (0-29) and Problem solving (0-11). This is scored based on percent of items correct, so higher scores represent a better outcome.
Outcome measures
| Measure |
DIPPer Academy
n=15 Participants
Parents randomized to this group will participate in the DIPPer Academy curriculum.
DIPPer Academy: The DIPPer Academy curricula will build on treatment models guided by the Health Beliefs Model (HBM) and Social Cognitive Theory (SCT). The curricula includes video microlectures, personalize progress reports, and other features delivered via the internet.
|
Standard of Care Control
n=9 Participants
Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team.
|
|---|---|---|
|
Parent Knowledge of T1D
|
98.94 percentage of correct items
Standard Deviation 2.17
|
97.70 percentage of correct items
Standard Deviation 2.99
|
SECONDARY outcome
Timeframe: Absolute value at Post-treatment (Week 33)Population: lost to follow-up n=5 parents in DIPPer group and n=2 parents in standard care at 33 weeks; parents withdrew themselves.
Measured using the Behavioral Pediatrics Feeding Assessment Scale. This is a 35 item scale. This subscale reflects the number of mealtime behaviors that parents identify as problematic (possible range: 0-35). Higher scores represent a worse outcome.
Outcome measures
| Measure |
DIPPer Academy
n=15 Participants
Parents randomized to this group will participate in the DIPPer Academy curriculum.
DIPPer Academy: The DIPPer Academy curricula will build on treatment models guided by the Health Beliefs Model (HBM) and Social Cognitive Theory (SCT). The curricula includes video microlectures, personalize progress reports, and other features delivered via the internet.
|
Standard of Care Control
n=9 Participants
Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team.
|
|---|---|---|
|
Behavioral Pediatric Feeding Assessment Scale_Problem
|
2.15 score on a scale
Standard Deviation 2.85
|
7.18 score on a scale
Standard Deviation 9.48
|
Adverse Events
DIPPer Academy- Parents
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care Control- Parents
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DIPPer Academy- Children
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care Control- Children
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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