NCT00970294

Brief Summary

Limited participation in health promotion activities is noted in people with diabetes, even though lifestyle changes have been found to be essential in decreasing the risk of complications of the disease. The purpose of this study is to gather preliminary data to assess the feasibility of an intense, customized health promotion program in people with diabetes, and to evaluate outcome measures following participation to determine effect size for future studies. Subjects with type 2 diabetes will participate in a 10-week health promotion program, at a frequency of 3-4 days per week. The intervention will include aerobic and strength training exercises with a schedule of progression, individual nutrition counseling, and diabetes health education sessions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Jul 2007

Shorter than P25 for not_applicable diabetes

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

July 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
3 years until next milestone

Results Posted

Study results publicly available

August 21, 2012

Completed
Last Updated

August 21, 2012

Status Verified

July 1, 2012

Enrollment Period

10 months

First QC Date

September 1, 2009

Results QC Date

May 29, 2012

Last Update Submit

July 18, 2012

Conditions

Diabetes

Keywords

diabetes

Outcome Measures

Primary Outcomes (1)

  • Recruitment, Retention, Adherence

    % of enrolled subjects who completed the trial

    10 weeks

Secondary Outcomes (2)

  • Aerobic Fitness

    Baseline and at 10 weeks (change score)

  • Glycemic Control

    Baseline and at 10 weeks (change score)

Study Arms (1)

Health Promotion Program

EXPERIMENTAL

Supervised exercise, educational sessions, dietary counseling

Behavioral: Health Promotion Program

Interventions

Health Promotion ProgramBEHAVIORAL

10 week health promotion program 3-4 times per week

Health Promotion Program

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diabetes type II
  • age 40-70

You may not qualify if:

  • hospitalization for myocardial infarction, heart surgery, or congestive heart failure during the preceding 3 months
  • significant cardiac arrythmia, hypertrophic cardiomyopathy, severe aortic stenosis, or pulmonary embolus
  • recent symptoms of chest discomfort
  • currently smoking or significant pulmonary pathology
  • serious musculoskeletal problems that would limit ability to exercise
  • current active involvement in a regular exercise program (\> 3 times per week)
  • open wounds on the weight bearing surface of the feet
  • not able to ambulate independently
  • stroke or other central nervous system pathology
  • stage 2 hypertension (resting blood pressure \> 160 systolic or \> 100 diastolic)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Patricia Kluding PhD

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

  • Kluding PM, Singh R, Goetz J, Rucker J, Bracciano S, Curry N. Feasibility and effectiveness of a pilot health promotion program for adults with type 2 diabetes: lessons learned. Diabetes Educ. 2010 Jul-Aug;36(4):595-602. doi: 10.1177/0145721710370718. Epub 2010 Jun 8.

    PMID: 20530663RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Patricia Kluding PT PhD
Organization
University of Kansas Medical Center
pkluding@kumc.edu
913-588-6918

Study Officials

  • Patricia Kluding, PhD

    University of Kansas Medical Center

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 1, 2009

First Posted

September 2, 2009

Study Start

July 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

August 21, 2012

Results First Posted

August 21, 2012

Record last verified: 2012-07

Locations

US(1)