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Completed

NCT Number: NCT03385265

Iterative Beta Testing of Videos for the DIPPer Academy

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.

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Key information

Conditions

Age range

3 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center, Kansas City, Kansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

DIPPer Academy

Behavioral

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

Other

Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by the diabetes team.

Primary outcomes

  1. Child Glycemic Control

    Time frame: absolute value Post-treatment (Week 33)

    Measure of hemoglobin A1c (HbA1c).

  2. 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.

  3. 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

Secondary outcomes

  1. Family Mealtime behaviors_Frequency

    Time frame: 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.

  2. Parents' Hypoglycemia Fear

    Time frame: 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.

  3. Parenting Stress- Frequency

    Time frame: 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

  4. Parents' T1D Self-efficacy

    Time frame: 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.

  5. Parent Knowledge of T1D

    Time frame: 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.

  6. Behavioral Pediatric Feeding Assessment Scale_Problem

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

An Interactive mHealth App for Better Glycemic Control in Parents of Young Kids With T1D

Acronym: DIPPer Academy

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 28, 2017
Registry last updated
Mar 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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