Pet Ownership and Glucose Control in Type 1 Diabetes

June 1, 2016 updated by: Olga Gupta, University of Texas Southwestern Medical Center

Impact of Pet Ownership on Glycemic Control in Youth With Type 1 Diabetes

The investigators' long-term goal is to discover novel, inexpensive and feasible strategies to improve the management and well-being of youth with T1DM. The specific objective of this proposal is to quantify the impact of responsible pet ownership on the glycemic control and health related quality of life in youth with T1DM.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Type 1 diabetes mellitus (T1DM) affects 151,000 children and adolescents in the United States. Youth with T1DM are at a high risk for multiple psychosocial co-morbidities including poor health related quality of life (HRQoL) which is linked to medication non-compliance and increased risk for diabetes-related complications. Any reduction in the psychosocial adjustment difficulties related to T1DM could improve the medical outcome of children with T1DM.

Current standards for diabetes management reflect the need to maintain glucose control within a normal range. However, numerous reports indicate that normalization of blood glucose levels is seldom attainable in children and adolescents. Family cohesion, positive coping strategies, younger age of onset, social support and adequate self-regulatory behavior are found to favorably influence glycemic control. One may conclude that the presence of a companion animal, capable of enhancing the positive factors named above, would augment the array of tools available for the successful management of chronic illnesses such as T1DM.

There is a lack of studies assessing the impact of pet ownership on the health and well-being of adolescents. The process of caring for, loving and being loved by a companion animal could offer direct and/or indirect benefits to the HRQoL in children with T1DM. To the investigators' knowledge, there are no studies examining the impact of pet ownership on glycemic control and HRQoL in youth with T1DM.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • English-speaking patients
  • 10 to 18 years
  • diagnosed with type 1 diabetes for at least 12 months
  • poor diabetes control as defined by having a hemoglobin A1c value > 8%

Exclusion Criteria:

  • type 2 diabetes
  • developmental delay
  • current participation in another study that may impact glycemic control

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Picture of a fish
Participants will receive a picture of a betta fish.
Behavioral: Picture of a fish
Participants will receive a picture of a betta fish.
Active Comparator: Pet fish
Participants will receive a betta fish and the supplies to care for the fish for a one year time period.
Behavioral: Pet Fish
Participants will receive a betta fish and the supplies to care for the fish for a one year time period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: 12 months
Hemoglobin A1c values
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HRQoL
Time Frame: 9 months
Generic and diabetes-specific health related quality of life
9 months
Self Management of Diabetes in Adolescents
Time Frame: 12 months
Self management of diabetes in adolescence questionnaire
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health care burden
Time Frame: 12 months
Number of visits to the Emergency Department and inpatient hospitalizations for poor glycemic control
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

University of Massachusetts, Worcester

Investigators

  • Principal Investigator: Olga T Gupta, MD, UT Southwestern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

November 2, 2012

First Submitted That Met QC Criteria

November 20, 2012

First Posted (Estimate)

November 27, 2012

Study Record Updates

Last Update Posted (Estimate)

June 2, 2016

Last Update Submitted That Met QC Criteria

June 1, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R03HD071263-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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