Activity Monitoring and Counseling in a Geriatric Population

NCT ID: NCT01502007

Last Updated: 2014-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2013-03-31

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%.

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Accelerometer feedback and lifestyle counseling

Intervention Type: OTHER

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. The control group will receive no counseling for the first 26 weeks of the study and will then crossover to get accelerometry feedback and counseling for the last 24 weeks of the study.

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.

Group Type: EXPERIMENTAL

Accelerometer without Feedback

Intervention Type: OTHER

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. This group will receive feedback from the accelerometer for the remainder of the study. The control group will wear the Fitbit but receive no feedback for the first 26 weeks of the study. For the last 24 weeks they will crossover and receive feedback from the Fitbit accelerometer.

Interventions

Accelerometer feedback and lifestyle counseling

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. The control group will receive no counseling for the first 26 weeks of the study and will then crossover to get accelerometry feedback and counseling for the last 24 weeks of the study.

Intervention Type: OTHER

Accelerometer without Feedback

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. This group will receive feedback from the accelerometer for the remainder of the study. The control group will wear the Fitbit but receive no feedback for the first 26 weeks of the study. For the last 24 weeks they will crossover and receive feedback from the Fitbit accelerometer.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Volunteers from the public including subjects in the independent living section of Assisted Living Facilities between the ages of 65 and 85.
• Those over 85 may participate with their personal physician's consent.
• BMI 25-40 kg/m2 OR a waist circumference 88 cm or greater in women or 102 cm or greater in men
• Sedentary (no more than 30 minutes of vigorous or 90 minutes of moderate activity per week)
• Complete a Timed Get Up and Go test in <= 20 seconds
• If walking is done with an assistive device, the subject must have no history of falling with the use of said device)
• Subjects will complete the Physical Activity Readiness Questionnaire - Revised (PARQ-R) which is as follows:

1. Has your doctor ever said that you have a heart condition and that you should only do physical activity recommended by a doctor?

2. Do you feel pain in your chest when you do physical activity?

3. In the past month, have you had chest pain when you were not doing physical activity?

4. Do you lose your balance because of dizziness, or do you ever lose consciousness?

5. Do you have a bone or joint problem that could be made worse by a change in your physical activity?

6. Is your doctor currently prescribing drugs (for example, water pills) for your blood pressure or heart condition?

7. Do you know of any other reason why you should not do physical activity? Subjects who respond "yes" to any of the above questions will require written permission from their physician to participate in this study.

Exclusion Criteria

• Significant cognitive impairment (score on Mini-Cog less than 3).
• Diabetics on medication
• Subjects who should not participate in an exercise program will not be eligible for the study.
• Angina or a history of myocardial infarction
• Cancer (other than non-melanoma skin cancer) will not be eligible.
• Uncompensated liver disease
• Uncompensated thyroid disease
• Severe osteoporosis
• Any medical condition which might lead to weight loss or weight gain
• Patients on the following medications: antidepressants (those on bupropion and stable doses of selective serotonin re-uptake inhibitors (SSRIs) and trazodone will be included), antipsychotics, topiramate, orlistat, or phentermine (Patients on statins will be eligible if no change in their medication is planned over the next 6 months)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

JR Albert Foundation

UNKNOWN

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Warren G. Thompson

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Warren Thompson, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

References

Thompson WG, Kuhle CL, Koepp GA, McCrady-Spitzer SK, Levine JA. "Go4Life" exercise counseling, accelerometer feedback, and activity levels in older people. Arch Gerontol Geriatr. 2014 May-Jun;58(3):314-9. doi: 10.1016/j.archger.2014.01.004. Epub 2014 Jan 15.

Reference Type: DERIVED

PMID: 24485546 (View on PubMed)

Other Identifiers

09-008672

Identifier Type: -

Identifier Source: org_study_id