NCT03385265

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 28, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
6 months until next milestone

Results Posted

Study results publicly available

March 11, 2022

Completed
Last Updated

March 11, 2022

Status Verified

March 1, 2022

Enrollment Period

3.6 years

First QC Date

December 20, 2017

Results QC Date

January 3, 2022

Last Update Submit

March 10, 2022

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • Family Mealtime behaviors_Frequency

    absolute value at Post-treatment (Week 33)

  • Parents' Hypoglycemia Fear

    absolute value at Post-treatment (Week 33)

  • Parenting Stress- Frequency

    Absolute value at Post-treatment (Week 33)

  • Parents' T1D Self-efficacy

    Absolute value at Post-treatment (Week 33)

  • Parent Knowledge of T1D

    Absolute value at Post-treatment (Week 33)

  • +1 more secondary outcomes

Study Arms (2)

DIPPer Academy

EXPERIMENTAL

Parents randomized to this group will participate in the DIPPer Academy curriculum.

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

Other: Standard of Care

Interventions

DIPPer AcademyBEHAVIORAL

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.

DIPPer Academy
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.

Standard of Care Control

Eligibility Criteria

Age3 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

The Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Limitations and Caveats

Small sample size leading to limited power to examine for treatment effects.

Results Point of Contact

Title
Dr. Susana Patton
Organization
Nemours Children's Health
susana.patton@nemours.org
904-697-2000

Study Officials

  • Eve-Lynn Nelson, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2017

First Posted

December 28, 2017

Study Start

January 1, 2018

Primary Completion

July 29, 2021

Study Completion

September 1, 2021

Last Updated

March 11, 2022

Results First Posted

March 11, 2022

Record last verified: 2022-03

Locations

US(2)