Activity Monitoring and Counseling in a Geriatric Population

This study has been completed.
Sponsor:
Collaborator:
JR Albert Foundation
Information provided by (Responsible Party):
Warren G. Thompson, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01502007
First received: November 29, 2011
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

The goal of the study is to determine if an activity measurement device (accelerometer) which provides feedback to subjects combined with an activity counseling program will result in an increase in physical activity of at least 20%.


Condition Intervention
Overweight
Obesity
Device: Fitbit Accelerometer (Fitbit, inc.)
Device: Accelerometer without Feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Activity Monitoring and Counseling in a Geriatric Population: a Randomized Trial

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in Activity units as determined by Accelerometry [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body weight in kilograms [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Body fat by DEXA scan [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Waist to hip ratio [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Fasting glucose [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Hemoglobin A1c [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Fasting insulin [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Fasting lipid profile [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • high sensitivity c-reactive protein [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Body Mass Index [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: April 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 device and receive feedback about their activity levels for an additional 24 weeks, but they will no longer receive counseling.
Device: Fitbit Accelerometer (Fitbit, inc.)
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.
Experimental: 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.
Device: Accelerometer without Feedback
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 device 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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 PARQ-R (Physical Activity Readiness Questionnaire - Revised) 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 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01502007

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
JR Albert Foundation
Investigators
Principal Investigator: Warren Thompson, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Warren G. Thompson, Associate Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01502007     History of Changes
Other Study ID Numbers: 09-008672
Study First Received: November 29, 2011
Last Updated: June 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Activity Level
Overweight
Obesity

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014