Pet Ownership and Glucose Control in Type 1 Diabetes

NCT ID: NCT01733524

Last Updated: 2016-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Picture of a fish

Participants will receive a picture of a betta fish.

Group Type SHAM_COMPARATOR

Picture of a fish

Intervention Type BEHAVIORAL

Participants will receive a picture of a betta fish.

Pet fish

Participants will receive a betta fish and the supplies to care for the fish for a one year time period.

Group Type ACTIVE_COMPARATOR

Pet Fish

Intervention Type BEHAVIORAL

Participants will receive a betta fish and the supplies to care for the fish for a one year time period.

Interventions

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Pet Fish

Participants will receive a betta fish and the supplies to care for the fish for a one year time period.

Intervention Type BEHAVIORAL

Picture of a fish

Participants will receive a picture of a betta fish.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Massachusetts, Worcester

OTHER

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Olga Gupta

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olga T Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern

Locations

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University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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1R03HD071263-01

Identifier Type: NIH

Identifier Source: org_study_id

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