Pet Ownership and Glucose Control in Type 1 Diabetes | NCT01733524

Studies
Pet Ownership and Glucose Control in Type 1 Diabetes

NCT01733524

Sponsor

University of Texas Southwestern Medical Center

Status

Completed

Last Update Posted

Jun 2, 2016Estimated

Enrollment

29Actual

Phase

Not Applicable

Conditions

Type 1 Diabetes Mellitus

Interventions

Pet Fish
Picture of a fish

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Nov 2, 2012

First Submission Date that Met QC Criteria

Nov 20, 2012

First Posted Date

Nov 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2016

Last Update Posted Date

Jun 2, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Olga Gupta, Assistant Professor, University of Texas Southwestern Medical CenterPrincipal Investigator

Lead Sponsor

University of Texas Southwestern Medical CenterOTHER

Collaborators

Name	Class
University of Massachusetts, Worcester	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Picture of a fish	Sham Comparator	Participants will receive a picture of a betta fish.	Behavioral: Picture of a fish
Pet fish	Active Comparator	Participants will receive a betta fish and the supplies to care for the fish for a one year time period.	Behavioral: Pet Fish

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pet Fish	Behavioral	Participants will receive a betta fish and the supplies to care for the fish for a one year time period.	Pet fish

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glycemic control	Hemoglobin A1c values	12 months

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olga T Gupta, MD	UT Southwestern	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas Southwestern Medical Center		Dallas	Texas	75390	United States

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided