Type1diabetes
Conditions
Brief summary
The purpose of this research is to develop DIPPer Academy, a parent-focused, mobile health (mHealth) behavioral intervention to promote glycemic control in young children.
Detailed description
Because many young children with T1D have glucose levels that exceed targets, investigators need to develop efficacious, accessible, and readily disseminable interventions to help them to improve their glycemic control. To do this, the investigators need efficacious interventions that specifically address the challenges that parents of young children face in daily T1D management. Providers need mHealth interventions that minimize barriers that parents experience when trying to access face-to-face or in clinic interventions. Finally, interventions are needed that are packaged to be easily deployable by other diabetes centers. The investigator's proposed intervention, DIPPer Academy, will include all of these recommended advancements.
Interventions
BEHAVIORALDIPPer 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.
OTHERStandard of Care
Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by the diabetes team.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Parents of a young child who is between 3-5.99 years old and at least 6 months post T1D diagnosis * Parents who are English-speaking.
Exclusion criteria
* Parents of young children with evidence of type 2 diabetes or monogenic diabetes. * Parents with evidence of severe psychiatric disorder. * Parents of young children with a comorbid chronic illness (e.g., renal disease) that requires ongoing care beyond T1D. * Parents of young children with a history of anemia or medication use that may interact with glycemic control (e.g., systemic steroids).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Glycemic Control | absolute value Post-treatment (Week 33) | Measure of hemoglobin A1c (HbA1c). |
| Parent Depressive Symptoms | absolute value Post-treatment (Week 33) | Center for Epidemiological Studies-Depression Scale Revised (CES-D); higher scores suggest worse outcome. Range 0-60. |
| Parent Diabetes Distress | Absolute value at Post-treatment (Week 33) | Problem Areas in Diabetes Distress- Parent Report Questionnaire. Higher scores reflect worse outcome. Range 0-72 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parents' T1D Self-efficacy | Absolute value at Post-treatment (Week 33) | 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. |
| Family Mealtime behaviors_Frequency | absolute value at Post-treatment (Week 33) | 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. |
| Behavioral Pediatric Feeding Assessment Scale_Problem | Absolute value at Post-treatment (Week 33) | 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. |
| Parent Knowledge of T1D | Absolute value at Post-treatment (Week 33) | 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. |
| Parents' Hypoglycemia Fear | absolute value at Post-treatment (Week 33) | Measured using the Hypoglycemia Fear Survey (HFS-PYC). This is a 26 item measure and higher values represent a worse outcome. Range: 26-130. |
| Parenting Stress- Frequency | Absolute value at Post-treatment (Week 33) | 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 |
Countries
United States
Participant flow
Recruitment details
recruited in clinic or by telephone.
Pre-assignment details
pre-assignment all parents completed baseline assessment measures
Participants by arm
| Arm | Count |
|---|---|
| DIPPer Academy- Parents 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. | 20 |
| 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. | 11 |
| DIPPer Academy- Children 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. | 20 |
| Standard of Care Control- 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 children's HbA1c level. | 11 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 5 | 2 | 5 | 2 |
Baseline characteristics
| Characteristic | DIPPer Academy- Parents | Standard of Care Control- Parents | DIPPer Academy- Children | Standard of Care Control- Children | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 20 Participants | 11 Participants | 31 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 11 Participants | 0 Participants | 0 Participants | 31 Participants |
| Age, Continuous | 36.25 years STANDARD_DEVIATION 4.82 | 32.64 years STANDARD_DEVIATION 5.98 | 4.98 years STANDARD_DEVIATION 0.89 | 4.42 years STANDARD_DEVIATION 0.89 | 19.87 years STANDARD_DEVIATION 15.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 10 Participants | 20 Participants | 10 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 11 Participants | 17 Participants | 11 Participants | 56 Participants |
| Sex: Female, Male Female | 19 Participants | 11 Participants | 9 Participants | 4 Participants | 43 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 11 Participants | 7 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 9 | 0 / 15 | 0 / 9 |
| other Total, other adverse events | 0 / 15 | 0 / 9 | 0 / 15 | 0 / 9 |
| serious Total, serious adverse events | 0 / 15 | 0 / 9 | 0 / 15 | 0 / 9 |
Outcome results
Primary
Child Glycemic Control
Measure of hemoglobin A1c (HbA1c).
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DIPPer Academy | Child Glycemic Control | 7.56 percentage of glycated hemoglobin cells | Standard Deviation 1.17 |
| Standard of Care Control | Child Glycemic Control | 8.14 percentage of glycated hemoglobin cells | Standard Deviation 0.73 |
repeated measures ANOVA
Primary
Parent Depressive Symptoms
Center for Epidemiological Studies-Depression Scale Revised (CES-D); higher scores suggest worse outcome. Range 0-60.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DIPPer Academy | Parent Depressive Symptoms | 10.0 units on a scale | Standard Deviation 9.35 |
| Standard of Care Control | Parent Depressive Symptoms | 7.33 units on a scale | Standard Deviation 8.28 |
repeated measures ANOVA
Primary
Parent Diabetes Distress
Problem Areas in Diabetes Distress- Parent Report Questionnaire. Higher scores reflect worse outcome. Range 0-72
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DIPPer Academy | Parent Diabetes Distress | 29.23 units on a scale | Standard Deviation 18.86 |
| Standard of Care Control | Parent Diabetes Distress | 27.36 units on a scale | Standard Deviation 10.29 |
repeated measures ANOVA
Secondary
Behavioral Pediatric Feeding Assessment Scale_Problem
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DIPPer Academy | Behavioral Pediatric Feeding Assessment Scale_Problem | 2.15 score on a scale | Standard Deviation 2.85 |
| Standard of Care Control | Behavioral Pediatric Feeding Assessment Scale_Problem | 7.18 score on a scale | Standard Deviation 9.48 |
repeated measures ANOVA
Secondary
Family Mealtime behaviors_Frequency
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DIPPer Academy | Family Mealtime behaviors_Frequency | 78.23 units on a scale | Standard Deviation 13.81 |
| Standard of Care Control | Family Mealtime behaviors_Frequency | 92.67 units on a scale | Standard Deviation 14.93 |
repeated measures ANOVA
Secondary
Parenting Stress- Frequency
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DIPPer Academy | Parenting Stress- Frequency | 95.77 units on a scale | Standard Deviation 32.78 |
| Standard of Care Control | Parenting Stress- Frequency | 90.44 units on a scale | Standard Deviation 27.55 |
p-value: <0.05repeated measures ANOVA
Secondary
Parent Knowledge of T1D
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DIPPer Academy | Parent Knowledge of T1D | 98.94 percentage of correct items | Standard Deviation 2.17 |
| Standard of Care Control | Parent Knowledge of T1D | 97.70 percentage of correct items | Standard Deviation 2.99 |
repeated measures ANOVA
Secondary
Parents' Hypoglycemia Fear
Measured using the Hypoglycemia Fear Survey (HFS-PYC). This is a 26 item measure and higher values represent a worse outcome. Range: 26-130.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DIPPer Academy | Parents' Hypoglycemia Fear | 71.08 units on a scale | Standard Deviation 15.96 |
| Standard of Care Control | Parents' Hypoglycemia Fear | 64.00 units on a scale | Standard Deviation 12.75 |
repeated measures ANOVA
Secondary
Parents' T1D Self-efficacy
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DIPPer Academy | Parents' T1D Self-efficacy | 34.62 units on a scale | Standard Deviation 3.91 |
| Standard of Care Control | Parents' T1D Self-efficacy | 33.67 units on a scale | Standard Deviation 3.54 |
repeated measures ANOVA