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Pet Ownership and Glucose Control in Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01733524
Recruitment Status : Completed
First Posted : November 27, 2012
Last Update Posted : June 2, 2016
Sponsor:
Collaborator:
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Olga Gupta, University of Texas Southwestern Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Behavioral: Pet Fish Behavioral: Picture of a fish Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Pet Ownership on Glycemic Control in Youth With Type 1 Diabetes
Study Start Date : October 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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.




Primary Outcome Measures :
  1. Glycemic control [ Time Frame: 12 months ]
    Hemoglobin A1c values


Secondary Outcome Measures :
  1. HRQoL [ Time Frame: 9 months ]
    Generic and diabetes-specific health related quality of life

  2. Self Management of Diabetes in Adolescents [ Time Frame: 12 months ]
    Self management of diabetes in adolescence questionnaire


Other Outcome Measures:
  1. Health care burden [ Time Frame: 12 months ]
    Number of visits to the Emergency Department and inpatient hospitalizations for poor glycemic control



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733524


Locations
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United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
University of Massachusetts, Worcester
Investigators
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Principal Investigator: Olga T Gupta, MD UT Southwestern
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Responsible Party: Olga Gupta, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01733524    
Other Study ID Numbers: 1R03HD071263-01 ( U.S. NIH Grant/Contract )
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: June 2, 2016
Last Verified: June 2016
Keywords provided by Olga Gupta, University of Texas Southwestern Medical Center:
adolescence
self care
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases