NCT01358643

Brief Summary

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. 1.To assess the effect of the intervention on weight, activity levels, depression, and adherence.
  2. 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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

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, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 24, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

June 2, 2011

Status Verified

May 1, 2011

Enrollment Period

1 year

First QC Date

May 19, 2011

Last Update Submit

June 1, 2011

Conditions

Keywords

OEF/OIFPhysical ActivityPreferences

Outcome Measures

Primary Outcomes (1)

  • 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

    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.

    6 weeks, 12 weeks

Secondary Outcomes (1)

  • Other health-related outcomes: Change from Baseline in health-related outcomes at 6 weeks and 12 weeks

    6 weeks, 12 weeks

Study Arms (3)

P90X + Sparkpeople

OTHER

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

P90X + BodyMedia Fit

OTHER

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

BodyMedia Fit + Sparkpeople

OTHER

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

Interventions

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 + SparkpeopleP90X + BodyMedia FitP90X + Sparkpeople

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Currently pregnant;
  • Cannot walk at least one block;
  • Have been referred to the ASPIRE program or are participating in the ASIPRE program;
  • Have dial-up internet access only;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Caroline Richardson, MD

    VA Ann Arbor Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
FED

Study Record Dates

First Submitted

May 19, 2011

First Posted

May 24, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

May 1, 2012

Last Updated

June 2, 2011

Record last verified: 2011-05

Locations