Iterative Beta Testing of Videos for the DIPPer Academy (DIPPer Academy)

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.

Study Overview

• Status: Completed
• Conditions: Type1diabetes
• Intervention / Treatment: Behavioral: DIPPer Academy; Other: Standard of Care

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • The Children's Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DIPPer Academy; Parents randomized to this group will participate in the DIPPer Academy curriculum.	Behavioral: 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.
Active Comparator: Standard of Care Control; Parents randomized to this group will receive care as usual from their child's diabetes provider	Other: Standard 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Glycemic Control	Measure of hemoglobin A1c (HbA1c).	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.	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	Absolute value at Post-treatment (Week 33)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	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.	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.	Absolute value at Post-treatment (Week 33)

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Eve-Lynn Nelson, PhD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): July 29, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 28, 2017

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 15040153; 1DP3DK108211-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No