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Pet Ownership and Glucose Control in Type 1 Diabetes

This study is currently recruiting participants.
Verified November 2012 by University of Texas Southwestern Medical Center
Sponsor:
Collaborator:
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Olga Gupta, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01733524
First received: November 2, 2012
Last updated: November 20, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Type 1 Diabetes Mellitus
 Behavioral: Pet Fish
Behavioral: Picture of a fish

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Impact of Pet Ownership on Glycemic Control in Youth With Type 1 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Glycemic control [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Hemoglobin A1c values


Secondary Outcome Measures:
  • HRQoL [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Generic and diabetes-specific health related quality of life

  • Self Management of Diabetes in Adolescents [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Self management of diabetes in adolescence questionnaire


Other Outcome Measures:
  • Health care burden [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of visits to the Emergency Department and inpatient hospitalizations for poor glycemic control


Estimated Enrollment: 80
Study Start Date: October 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733524

Contacts
Contact: Olga Gupta, M.D. (214) 648-8718 olga.gupta@utsouthwestern.edu

Locations
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Olga Gupta, M.D.         olga.gupta@utsouthwestern.edu    
Sponsors and Collaborators
University of Texas Southwestern Medical Center
University of Massachusetts, Worcester
Investigators
Principal Investigator: Olga T Gupta, MD UT Southwestern
  More Information

No publications provided

Responsible Party: Olga Gupta, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01733524     History of Changes
Other Study ID Numbers: 1-R03-HD071263-01
Study First Received: November 2, 2012
Last Updated: November 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
adolescence
self care

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013