NCT00334113

Brief Summary

The overarching objective of this study is to develop an innovative strategy to address the problems of obesity and diabetes by promoting exercise adoption. An automated telephone intervention will be developed that can be used to enhance exercise adoption over a twelve month period in a population of overweight or obese veterans with Type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable diabetes-mellitus-type-2

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

First Submitted

Initial submission to the registry

June 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2006

Completed
2.6 years until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

November 27, 2014

Completed
Last Updated

January 6, 2015

Status Verified

December 1, 2014

Enrollment Period

3.2 years

First QC Date

June 2, 2006

Results QC Date

November 21, 2014

Last Update Submit

December 16, 2014

Conditions

Diabetes Mellitus, Type 2Obesity

Keywords

Diabetes MellitusExerciseObesityTelemedicine

Outcome Measures

Primary Outcomes (1)

  • 7-Day Physical Activity Recall (PAR)

    A self-report measure of minutes of physical activity over the previous 7 days.

    six months

Study Arms (2)

Arm 1

EXPERIMENTAL

Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will recieve an intervention that will be delivered over an automated telephone system (TLC-PED). These automated phone calls with voice response and voice recognition capabilities will occur weekly over a 6 month period. During these calls, participants' physical activity will be monitored, new physical activities goals will be set, information about physical activity and the associated health benefits will be provided, and barriers to physical activity will be explored.

Behavioral: TLC-PED

Arm 2

NO INTERVENTION

This is the "treatment as usual" condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity.

Interventions

TLC-PEDBEHAVIORAL

Telephone-Linked Care - Promoting Exercise for Diabetes (TLC-PED), a method that uses interactive voice response and speech recognition technologies, will be developed to provide individualized and personalized motivational messages using automated telephone calls for veterans with Type 2 diabetes who participate in a home based walking program.

Arm 1

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of type 2 diabetes mellitus
  • Receive a medical clearance from physician
  • Be sedentary
  • Be interested in exercising
  • Have a BMI \> 25 kg/m2
  • Have an HbA1c between 7 \& 10%
  • Be on medication for diabetes

You may not qualify if:

  • Significant peripheral neuropathy
  • Active psychosis
  • Psych admission or substance abuse in the last 6 months
  • Severe brain dysfunction
  • Abnormal ECG
  • Orthopedic related limitations
  • Unable to understand English
  • No direct access to telephone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Jamaica Plain Campus

Boston, Massachusetts, 02130, United States

Location

Related Publications (1)

  • Seligowski AV, Pless Kaiser AP, Niles BL, Mori DL, King LA, King DW. Sleep quality as a potential mediator between psychological distress and diabetes quality of life in veterans with type 2 diabetes. J Clin Psychol. 2013 Oct;69(10):1121-31. doi: 10.1002/jclp.21866. Epub 2012 May 25.

    PMID: 22638910RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityDiabetes MellitusMotor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Results Point of Contact

Title
Dr. DeAnna Mori
Organization
VA Boston Healthcare System
deanna.mori@va.gov
857-364-4121

Study Officials

  • Deanna L Mori, PhD

    VA Medical Center, Jamaica Plain Campus

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2006

First Posted

June 6, 2006

Study Start

January 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

January 6, 2015

Results First Posted

November 27, 2014

Record last verified: 2014-12

Locations

US(1)