NCT03761251

Brief Summary

This study evaluates the short-term effects of incorporating the structured care of a pet fish into a diabetes self-care routine on glucose control in early adolescents with type 1 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 31, 2018

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2019

Completed
Last Updated

October 2, 2019

Status Verified

September 1, 2019

Enrollment Period

8 months

First QC Date

November 28, 2018

Last Update Submit

September 30, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

    Glycated hemoglobin test provides an average level of blood sugar over the past 3 months.

    3 months

Study Arms (1)

Pet Fish

EXPERIMENTAL

Participants will be instructed to partner thrice daily and once weekly fish care activities with diabetes care activities for 3 months

Behavioral: Pet Fish

Interventions

Pet FishBEHAVIORAL

Participants will be provided a fish tank with supplies to care for the fish and access to a fish (Betta splendens) from a local pet store. All participants will receive specific instructions for coupling the fish care and diabetes care: 1. feed fish one pellet in the morning after waking; check and record BG reading at that time 2. feed fish one pellet in the evening before dinner; check and record BG reading at that time 3. feed fish one pellet at night before bedtime; check and record BG reading at that time 4. every week clean the tank alternating with test the water quality in partnership with caregiver; review blood glucose readings with caregiver with each weekly fish care activity and problem solve any issues related to the blood glucose pattern. Each child will also receive two books intended to supplement and enrich their pet fish experience.

Pet Fish

Eligibility Criteria

Age10 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age 10-13 years
  • diagnosis of T1DM
  • duration of T1DM for at least one year
  • fluency in English
  • two recent consecutive HbA1c values 8.0 - 13%

You may not qualify if:

  • clinical or laboratory characteristics suggestive of type 2 diabetes mellitus
  • involvement in foster care
  • dual-home living situation
  • severe psychiatric disorders
  • developmental delay or cognitive impairment
  • current participation in another study that may impact glycemic control
  • regular usage of a continuous glucose monitor
  • HbA1c \> 13% (because these individuals may need a more intensive intervention than this is intended to provide).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Adolescent Behavior

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 28, 2018

First Posted

December 3, 2018

Study Start

October 31, 2018

Primary Completion

July 9, 2019

Study Completion

September 25, 2019

Last Updated

October 2, 2019

Record last verified: 2019-09

Locations