Clinical trial NCT01502007: Activity Monitoring and Counseling in a Geriatric Population
Official title: Activity Monitoring and Counseling in a Geriatric Population: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Activity Level
Overweight
Obesity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: JR Albert Foundation
First posted: 2011-12-30
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.


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)

Primary outcomes:
measure: Change in Activity units as determined by Accelerometry
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Body weight in kilograms
timeFrame: 6 and 12 months
measure: Body fat by bone density scan (DEXA)
timeFrame: 6 and 12 months
measure: Waist to hip ratio
timeFrame: 6 and 12 months
measure: Fasting glucose
timeFrame: 6 and 12 months
measure: Hemoglobin A1c
timeFrame: 6 and 12 months
measure: Fasting insulin
timeFrame: 6 and 12 months
measure: Fasting lipid profile
timeFrame: 6 and 12 months
measure: high sensitivity c-reactive protein
timeFrame: 6 and 12 months
measure: Body Mass Index
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Warren Thompson, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.