Clinical trial NCT03385265: Iterative Beta Testing of Videos for the DIPPer Academy
Official title: An Interactive mHealth App for Better Glycemic Control in Parents of Young Kids With T1D
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1diabetes
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-12-28
Enrollment: 62
Sex: ALL
Minimum age (years): 3
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Child Glycemic Control
timeFrame: absolute value Post-treatment (Week 33)
measure: Parent Depressive Symptoms
timeFrame: absolute value Post-treatment (Week 33)
measure: Parent Diabetes Distress
timeFrame: Absolute value at Post-treatment (Week 33)
Secondary outcomes:
measure: Family Mealtime behaviors_Frequency
timeFrame: absolute value at Post-treatment (Week 33)
measure: Parents' Hypoglycemia Fear
timeFrame: absolute value at Post-treatment (Week 33)
measure: Parenting Stress- Frequency
timeFrame: Absolute value at Post-treatment (Week 33)
measure: Parents' T1D Self-efficacy
timeFrame: Absolute value at Post-treatment (Week 33)
measure: Parent Knowledge of T1D
timeFrame: Absolute value at Post-treatment (Week 33)
measure: Behavioral Pediatric Feeding Assessment Scale_Problem
timeFrame: Absolute value at Post-treatment (Week 33)
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Kansas City
country: United States
facility: The Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: University of Kansas Medical Center
name: Eve-Lynn Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
References: