NCT01790724

Brief Summary

The propose of the study is to test the hypothesis that an eight week program consisting of walking exercise and social cognitive theory based group workshops will increase physical activity adherence six months later in older adults with type 2 diabetes or metabolic syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

11 months

First QC Date

February 11, 2013

Last Update Submit

February 21, 2017

Conditions

Diabetes Type 2Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Physical Activity

    Change from baseline to month six in physical activity. Participants will wear an accelerometer to measure physical activity.

    Month 6

Secondary Outcomes (5)

  • Self-efficacy

    Month 6

  • Executive function

    Month 6

  • Self-regulatory strategy use

    Month 6

  • Physical function

    Month 6

  • Psychosocial outcomes

    Month 6

Study Arms (2)

Walking exercise

EXPERIMENTAL

Participants will be instructed in safe walking exercise. They will participate in an eight week, tapered, on-site program. Participants will also attend group workshops where they will learn self-regulatory skills such as goal-setting, self-monitoring, barrier trouble-shooting, rewarding, and relapse prevention and recovery.

Behavioral: Walking exercise

Metabolic health education

ACTIVE COMPARATOR

Participants will complete an eight-week online metabolic health education course. Topics will include glucose control, insulin, weight management, nutrition, physical activity, eye/kidney/foot health, stress reduction, and doctor-patient communication.

Behavioral: Walking exercise

Interventions

Walking exerciseBEHAVIORAL
Metabolic health educationWalking exercise

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults between the ages of 50-75 years
  • individuals diagnosed with type 2 diabetes or metabolic syndrome (presence of 3 of the 5 criteria)
  • physician consent to participate.

You may not qualify if:

  • below age 50 or above age 75 at the beginning of the intervention
  • exercising regularly more than twice per week for the last six months
  • diagnosis of type 1 diabetes mellitus
  • failing the Telephone Interview of Cognitive Status
  • inability to communicate in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

Related Publications (1)

  • Olson EA, Mullen SP, Raine LB, Kramer AF, Hillman CH, McAuley E. Integrated Social- and Neurocognitive Model of Physical Activity Behavior in Older Adults with Metabolic Disease. Ann Behav Med. 2017 Apr;51(2):272-281. doi: 10.1007/s12160-016-9850-4.

    PMID: 27844326DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Metabolic Syndrome

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinism

Study Officials

  • Edward McAuley, PhD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 11, 2013

First Posted

February 13, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2013

Study Completion

May 1, 2014

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

US(1)