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Activity Monitoring and Counseling in a Geriatric Population

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Accelerometer feedback and lifestyle counseling
Accelerometer without Feedback
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Activity Level, Overweight, Obesity

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Accelerometer feedback and lifestyle counseling

Accelerometer without Feedback

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Activity units as determined by Accelerometry

Secondary Outcome Measures

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

Full Information

First Posted
November 29, 2011
Last Updated
June 5, 2014
Sponsor
Mayo Clinic
Collaborators
JR Albert Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01502007
Brief Title
Activity Monitoring and Counseling in a Geriatric Population
Official Title
Activity Monitoring and Counseling in a Geriatric Population: a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
JR Albert Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Activity Level, Overweight, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Accelerometer feedback and lifestyle counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Accelerometer without Feedback
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Accelerometer feedback and lifestyle counseling
Intervention Description
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
Intervention Name(s)
Accelerometer without Feedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Activity units as determined by Accelerometry
Time Frame
6 and 12 months
Secondary Outcome Measure Information:
Title
Body weight in kilograms
Time Frame
6 and 12 months
Title
Body fat by bone density scan (DEXA)
Time Frame
6 and 12 months
Title
Waist to hip ratio
Time Frame
6 and 12 months
Title
Fasting glucose
Time Frame
6 and 12 months
Title
Hemoglobin A1c
Time Frame
6 and 12 months
Title
Fasting insulin
Time Frame
6 and 12 months
Title
Fasting lipid profile
Time Frame
6 and 12 months
Title
high sensitivity c-reactive protein
Time Frame
6 and 12 months
Title
Body Mass Index
Time Frame
6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: Has your doctor ever said that you have a heart condition and that you should only do physical activity recommended by a doctor? Do you feel pain in your chest when you do physical activity? In the past month, have you had chest pain when you were not doing physical activity? Do you lose your balance because of dizziness, or do you ever lose consciousness? Do you have a bone or joint problem that could be made worse by a change in your physical activity? Is your doctor currently prescribing drugs (for example, water pills) for your blood pressure or heart condition? 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warren Thompson, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24485546
Citation
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.
Results Reference
derived

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Activity Monitoring and Counseling in a Geriatric Population

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