NCT03121508

Brief Summary

The program will consist of diabetes self-management sessions, led by an occupational therapist. The sessions will be held in an individualized format. Sessions will focus on diabetes education, self-management education, and education on behaviors and adaptive techniques to optimize participation in daily life with type II diabetes. As occupational therapists, the investigators and facilitator, aim to focus on establishing healthy habits, roles, and routines for individuals with type 2 diabetes.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

April 24, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2018

Completed
Last Updated

July 12, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

April 13, 2017

Last Update Submit

July 10, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Diabetes Self-Management Questionnaire

    16-item self-report to assess self-care activities associated with diabetes

    through the end of the intervention period, up to one year

Study Arms (1)

TODAY Project

OTHER

All participants will attend individualized self-management sessions led by an occupational therapist. The classes will focus on promoting modifying daily activities, habits, roles, and routines to promote healthy lifestyles for individuals with type 2 diabetes.

Behavioral: Taking on Diabetes to Advance You (TODAY) Project

Interventions

This is an individualized educational intervention with activity components designed to assist in modifying habits, roles, and routines to promote healthy lifestyle patterns for individuals with type 2 diabetes.

TODAY Project

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes
  • or older
  • patient at the Family Medicine Center in Fort Collins

You may not qualify if:

  • reading level below 6th grade
  • inability to understand written or verbal instructions regarding questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Medicine Center

Fort Collins, Colorado, 80524, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Matt Malcolm, PhD

    Colorado State University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: The investigators will utilize an evidence-based self-management program, and all individuals will be assigned to the prevention group to promote healthy lifestyles.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Co-Investigator

Study Record Dates

First Submitted

April 13, 2017

First Posted

April 20, 2017

Study Start

April 24, 2017

Primary Completion

April 24, 2018

Study Completion

June 24, 2018

Last Updated

July 12, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations