Pet Ownership and Glucose Control in Early Adolescents With Type 1 Diabetes

NCT ID: NCT03761251

Last Updated: 2019-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-31
• Study Completion Date: 2019-09-25

Brief Summary

This study evaluates the short-term effects of incorporating the structured care of a pet fish into a diabetes self-care routine on glucose control in early adolescents with type 1 diabetes.

Detailed Description

Efficacy of treatment for Type 1 diabetes mellitus (T1DM) is dependent on adherence to self-care behaviors and collaborative parental involvement. Adolescence is a vulnerable time for the deterioration of glycemic control in patients with T1DM. In particular, parental monitoring declines during early adolescence. This often occurs before the child has developed self-efficacy and competence in independently performing diabetes-related tasks, including blood glucose monitoring. Consequently, there is a great need for innovative strategies in early adolescents that promote self-efficacy development and facilitate parental involvement.

Conditions

Diabetes Mellitus, Type 1; Adolescent Behavior

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pet Fish

Participants will be instructed to partner thrice daily and once weekly fish care activities with diabetes care activities for 3 months

Group Type: EXPERIMENTAL

Pet Fish

Intervention Type: BEHAVIORAL

Participants will be provided a fish tank with supplies to care for the fish and access to a fish (Betta splendens) from a local pet store. All participants will receive specific instructions for coupling the fish care and diabetes care:

1. feed fish one pellet in the morning after waking; check and record BG reading at that time

2. feed fish one pellet in the evening before dinner; check and record BG reading at that time

3. feed fish one pellet at night before bedtime; check and record BG reading at that time

4. every week clean the tank alternating with test the water quality in partnership with caregiver; review blood glucose readings with caregiver with each weekly fish care activity and problem solve any issues related to the blood glucose pattern.

Each child will also receive two books intended to supplement and enrich their pet fish experience.

Interventions

Pet Fish

Participants will be provided a fish tank with supplies to care for the fish and access to a fish (Betta splendens) from a local pet store. All participants will receive specific instructions for coupling the fish care and diabetes care:

1. feed fish one pellet in the morning after waking; check and record BG reading at that time

2. feed fish one pellet in the evening before dinner; check and record BG reading at that time

3. feed fish one pellet at night before bedtime; check and record BG reading at that time

4. every week clean the tank alternating with test the water quality in partnership with caregiver; review blood glucose readings with caregiver with each weekly fish care activity and problem solve any issues related to the blood glucose pattern.

Each child will also receive two books intended to supplement and enrich their pet fish experience.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• age 10-13 years
• diagnosis of T1DM
• duration of T1DM for at least one year
• fluency in English
• two recent consecutive HbA1c values 8.0 - 13%

Exclusion Criteria

• clinical or laboratory characteristics suggestive of type 2 diabetes mellitus
• involvement in foster care
• dual-home living situation
• severe psychiatric disorders
• developmental delay or cognitive impairment
• current participation in another study that may impact glycemic control
• regular usage of a continuous glucose monitor
• HbA1c > 13% (because these individuals may need a more intensive intervention than this is intended to provide).

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Olga Gupta

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

2018-0044

Identifier Type: -

Identifier Source: org_study_id