Type1diabetesDIPPer AcademyNCT03385265
Iterative Beta Testing of Videos for the DIPPer Academy
A study testing DIPPer Academy in people with Type1diabetes, run by University of Kansas Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 65 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- DIPPer Academy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2018to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kansas Medical Center
Kansas City, Kansas, 66160
The Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: An Interactive mHealth App for Better Glycemic Control in Parents of Young Kids With T1D
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.
Read the 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.
- Conditions
- Type1diabetes
- Being tested
- DIPPer Academy, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIPPer AcademyBehavioural
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 CareOther
Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by the diabetes team.
| Study group | Role | What they receive |
|---|---|---|
| DIPPer Academy | Experimental | Parents randomized to this group will participate in the DIPPer Academy curriculum. Receives: Behavioral: DIPPer Academy |
| Standard of Care Control | Active comparator | Parents randomized to this group will receive care as usual from their child's diabetes provider Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Glycemic Control
Measure of hemoglobin A1c (HbA1c).
Measured: absolute value Post-treatment (Week 33)
Parent Depressive Symptoms
Center for Epidemiological Studies-Depression Scale Revised (CES-D); higher scores suggest worse outcome. Range 0-60.
Measured: absolute value Post-treatment (Week 33)
Parent Diabetes Distress
Problem Areas in Diabetes Distress- Parent Report Questionnaire. Higher scores reflect worse outcome. Range 0-72
Measured: Absolute value at Post-treatment (Week 33)
Secondary outcomes (6)
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.
Measured: absolute value at Post-treatment (Week 33)
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.
Measured: absolute value at Post-treatment (Week 33)
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
Measured: Absolute value at Post-treatment (Week 33)
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.
Measured: Absolute value at Post-treatment (Week 33)
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.
Measured: Absolute value at Post-treatment (Week 33)
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.
Measured: Absolute value at Post-treatment (Week 33)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start1 Jan 2018
- Primary completion29 Jul 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eve-Lynn Nelson, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385265
- Sponsor's protocol ID
- 15040153
- Other IDs
- 1DP3DK108211-01
- Acronym
- DIPPer Academy
- Status last verified
- Mar 2022
- First submitted
- 20 Dec 2017
- Last updated
- 11 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interactive mHealth App for Better Glycemic Control in Parents of Young Kids With T1D
- ClinicalTrials.gov ID
- NCT03385265
- Acronym / sponsor ID
- DIPPer Academy / 15040153
- Conditions
- Type1diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 29 Jul 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 28 Dec 2017 (actual)
- Results
- Posted 11 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DIPPer Academy | Experimental | Behavioral: DIPPer AcademyParents randomized to this group will participate in the DIPPer Academy curriculum. |
| Standard of Care Control | Active comparator | Other: Standard of CareParents randomized to this group will receive care as usual from their child's diabetes provider |
Who may qualify
- Ages
- 3 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIPPer AcademyThe 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. | Behavioural | DIPPer Academy |
| Standard of CareParents in the standard of care control group will be instructed to manage their child's T1D as recommended by the diabetes team. | Other | Standard of Care Control |
Primary outcome
Child Glycemic Control
Time frame: absolute value Post-treatment (Week 33)
Measure of hemoglobin A1c (HbA1c).
Parent Depressive Symptoms
Time frame: 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
Time frame: Absolute value at Post-treatment (Week 33)
Problem Areas in Diabetes Distress- Parent Report Questionnaire. Higher scores reflect worse outcome. Range 0-72
6 secondary outcomes
Family Mealtime behaviors_Frequency
Time frame: absolute value at Post-treatment (Week 33)
Parents' Hypoglycemia Fear
Time frame: absolute value at Post-treatment (Week 33)
Parenting Stress- Frequency
Time frame: Absolute value at Post-treatment (Week 33)
Parents' T1D Self-efficacy
Time frame: Absolute value at Post-treatment (Week 33)
Parent Knowledge of T1D
Time frame: Absolute value at Post-treatment (Week 33)
Behavioral Pediatric Feeding Assessment Scale_Problem
Time frame: Absolute value at Post-treatment (Week 33)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eve-Lynn Nelson, PhD principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIPPer Academy in people with Type1diabetes, run by University of Kansas Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Glycemic Control (time frame: absolute value Post-treatment (Week 33)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.