Activity Monitoring and Counseling in a Geriatric Population

Not Applicable

Completed

• Conditions: Overweight; Obesity
• Interventions: Other: Accelerometer feedback and lifestyle counseling; Other: Accelerometer without Feedback

• Registration Number: NCT01502007
• Lead Sponsor: Mayo Clinic

Brief Summary

The goal of the study is to determine if a Fitbit, a kind of accelerometer, provides feedback to subjects combined with an activity counseling program will result in an increase in physical activity of at least 20%.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-11-29
• Study First Submitted QC: 2011-12-29
• Study First Posted: 2011-12-30
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-05
• Last Update Posted: 2014-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Accelerometer feedback and lifestyle counseling	Accelerometer feedback and lifestyle counseling	The accelerometer, Fitbit, will be worn continuously. Fitbit can provide feedback to subjects about their physical activity. Subjects will wear the Fitbit for two weeks (without feedback) to obtain baseline activity data. The experimental group will then be instructed on use of the fitbit. Subjects will meet with the exercise counselor who will use accelerometer data to provide feedback and counseling to help the user increase their activity by at least 20% each day. In subjects who achieve an increase of 20%, the counseling will focus either on maintaining activity levels or increasing activity further depending on the desire of the subject. Counseling will be provided once weekly by phone and in person at least once a month. Following the 26th week the experimental subjects will continue to wear the Fitbit and receive feedback about their activity levels for an additional 24 weeks, but they will no longer receive counseling.
Accelerometer without Feedback	Accelerometer without Feedback	The accelerometer, Fitbit, will be worn continuously. Subjects will wear the Fitbit for two weeks (without feedback) to obtain baseline activity data. The control group will continue to wear the fitbit for the next 24 weeks without any feedback or activity counseling. Following the 26th week of the study, the subjects in the control group will complete the same program given to the experimental group in weeks 2 through 26.

Primary Outcome Measures

Name	Time	Method
Change in Activity units as determined by Accelerometry	6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Fasting insulin	6 and 12 months
Body weight in kilograms	6 and 12 months
Body fat by bone density scan (DEXA)	6 and 12 months
Fasting lipid profile	6 and 12 months
Waist to hip ratio	6 and 12 months
Fasting glucose	6 and 12 months
Hemoglobin A1c	6 and 12 months
high sensitivity c-reactive protein	6 and 12 months
Body Mass Index	6 and 12 months

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States