Operations Enduring Freedom and Iraqi Freedom (OEF/OIF)Veteran Preferences for Automated Physical Activity Interventions

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
VA Ann Arbor Healthcare System
ClinicalTrials.gov Identifier:
NCT01358643
First received: May 19, 2011
Last updated: June 1, 2011
Last verified: May 2011
  Purpose

The purpose of this pilot is to assess the feasibility and potential effectiveness of three specific e-health approaches. One approach, SparkPeople.com, involves the use of social media and can be accessed through a free website. This approach has the potential to provide support through an on-line community as well as a number of diet/weight and physical activity related tools. A mobile phone application is also available for those with smart phones. The second approach, BodyMedia, involves the use of an objective monitoring device that tracks all activity. This information can be uploaded to a website to provide ongoing monitoring and feedback about activity and energy expenditure. The third approach, P90X, involves a DVD based resistance focused exercise program. While DVD programs are not necessarily considered e-health, participants will be encouraged to participate in online community forums associated with the program. All participants, regardless of randomization, will be given 4 point of decision prompts that are laminated 8.5x11 posters encouraging healthier behaviors to display in various areas of their home.

The specific aims are:

  1. To assess the effect of the intervention on weight, activity levels, depression, and adherence.
  2. To determine level of interest, perceptions, feasibility and satisfaction of the proposed interventions (i.e. SparkPeople.com vs. BodyMedia vs. P90X) with particular attention to: 1) social media; 2) food logs; 3) objective monitoring of physical activity; 4) use of point systems

Condition Intervention
Physical Activity
Other: Three home-based diet and exercise programs

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) Veteran Preferences for and Feasibility of Automated Physical Activity Interventions: A Pilot Study

Resource links provided by NLM:


Further study details as provided by VA Ann Arbor Healthcare System:

Primary Outcome Measures:
  • Perceptions of Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans of Different Physical Activity Interventions: Change from Baseline in perceptions of physical activity at 6 weeks and 12 weeks [ Time Frame: 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
    Perceptions of OEF/OIF Veterans of different physical activity interventions in an e-health program for promoting weight loss and increasing physical activity are the main outcome. Change from Baseline in perceptions of physical activity at 6 weeks and 12 weeks will be measured. These data will be used as pilot information for a larger study to assess the effectiveness of using an e-health approach to promote weight loss and increase physical activity among post-deployment Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) veterans who are at risk for developing diabetes.


Secondary Outcome Measures:
  • Other health-related outcomes: Change from Baseline in health-related outcomes at 6 weeks and 12 weeks [ Time Frame: 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
    Additionally, we seek to recognize any effects of the intervention on other health-related outcomes, such as stress, depression or other mental health measures, chronic pain, sleep, quality of life, satisfaction with care/Veteran Affairs Healthsystem, employment status, social support/connectedness. Change from Baseline in health-related outcomes (mentioned above) at 6 weeks and 12 weeks will be measured.


Estimated Enrollment: 30
Study Start Date: January 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
P90X + Sparkpeople

For six weeks of the study participants will use the P90X tools and for the other six weeks participants will use Sparkpeople tools.

Sparkpeople is a web based diet and exercise program in which the participant can track their diet and exercise progress and read and post messages to a large online community of others who are also trying to lose weight.

P90X is A DVD based home exercise program that guides the participant through a daily exercise routine.

Other: Three home-based diet and exercise programs

All research activities are outpatient. This pilot study will be a crossover study of two 6-week programs. The participant will be involved for 15 weeks.

Thirty OEF/OIF veterans with BMI > 30 will be recruited to test the diet and exercise programs. Each veteran will test only two of the three programs described above. The participants will use the the programs for six weeks then crossover and use a second program.

P90X + BodyMedia Fit

For six weeks participants will use the P90X tools and for the other six weeks participants will use the BodyMedia Fit Device.

P90X is a DVD based home exercise program that guides the participant through a daily exercise routine.

BodyMedia Fit is a program in which the participants wears a small device on their arm that measures their physical activity and allows you to upload detailed physical activity data to a web site to help them track your progress.

Other: Three home-based diet and exercise programs

All research activities are outpatient. This pilot study will be a crossover study of two 6-week programs. The participant will be involved for 15 weeks.

Thirty OEF/OIF veterans with BMI > 30 will be recruited to test the diet and exercise programs. Each veteran will test only two of the three programs described above. The participants will use the the programs for six weeks then crossover and use a second program.

BodyMedia Fit + Sparkpeople

For six weeks participants will use the BodyMedia Fit devise and for the other six weeks participants will use the Sparkpeople program.

BodyMedia Fit is a program in which the participants wears a small device on their arm that measures their physical activity and allows you to upload detailed physical activity data to a web site to help them track your progress.

Sparkpeople is A web based diet and exercise program in which the participant can track their diet and exercise progress and read and post messages to a large online community of others who are also trying to lose weight

Other: Three home-based diet and exercise programs

All research activities are outpatient. This pilot study will be a crossover study of two 6-week programs. The participant will be involved for 15 weeks.

Thirty OEF/OIF veterans with BMI > 30 will be recruited to test the diet and exercise programs. Each veteran will test only two of the three programs described above. The participants will use the the programs for six weeks then crossover and use a second program.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Identified as an Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) veteran;
  2. BMI of 30 or greater;
  3. Able to walk at least one block without stopping;
  4. Access to a computer on a daily basis with an available USB (universal serial bus) port with high-speed Internet access;
  5. Have a working email address;
  6. Have a working DVD player to view standard DVDs;
  7. be able to communicate in English.

Exclusion Criteria:

  1. Currently pregnant;
  2. Cannot walk at least one block;
  3. Have been referred to the ASPIRE program or are participating in the ASIPRE program;
  4. Have dial-up internet access only;
  5. Any medical condition that might make it dangerous or medically inappropriate to engage in a diet and exercise program as deemed by the study physician.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01358643

Locations
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
VA Ann Arbor Healthcare System
Investigators
Principal Investigator: Caroline Richardson, MD VA Ann Arbor Healthcare System
  More Information

No publications provided

Responsible Party: Caroline Richarson, MD, Va Ann Arbor Healthcare System
ClinicalTrials.gov Identifier: NCT01358643     History of Changes
Other Study ID Numbers: LIP 41-114
Study First Received: May 19, 2011
Last Updated: June 1, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by VA Ann Arbor Healthcare System:
OEF/OIF
Physical Activity
Preferences

ClinicalTrials.gov processed this record on September 18, 2014