OverweightNCT01502007
Activity Monitoring and Counseling in a Geriatric Population
A study testing Accelerometer feedback and lifestyle counseling and Accelerometer without Feedback in people with Overweight and Obesity, run by Mayo Clinic at 1 site in United States.
Trial 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%. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Accelerometer feedback and lifestyle counseling and Accelerometer without Feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Activity Monitoring and Counseling in a Geriatric Population: a Randomized Trial
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
- Being tested
- Accelerometer feedback and lifestyle counseling, Accelerometer without Feedback
- Keywords
- Activity Level, Overweight, Obesity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerometer feedback and lifestyle counselingOther
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 FeedbackOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Accelerometer feedback and lifestyle counseling | Experimental | 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. Receives: Other: Accelerometer feedback and lifestyle counseling |
| Accelerometer without Feedback | Experimental | 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. Receives: Other: Accelerometer without Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Activity units as determined by Accelerometry
Measured: 6 and 12 months
Secondary outcomes (9)
Body weight in kilograms
Measured: 6 and 12 months
Body fat by bone density scan (DEXA)
Measured: 6 and 12 months
Waist to hip ratio
Measured: 6 and 12 months
Fasting glucose
Measured: 6 and 12 months
Hemoglobin A1c
Measured: 6 and 12 months
Fasting insulin
Measured: 6 and 12 months
Fasting lipid profile
Measured: 6 and 12 months
high sensitivity c-reactive protein
Measured: 6 and 12 months
Body Mass Index
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- JR Albert Foundation
- Responsible party
- Principal investigator, Warren G. Thompson, Mayo Clinic
- Investigators
- Warren Thompson, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502007
- Sponsor's protocol ID
- 09-008672
- Status last verified
- Jun 2014
- First submitted
- 29 Nov 2011
- Last updated
- 6 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24485546
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activity Monitoring and Counseling in a Geriatric Population: a Randomized Trial
- ClinicalTrials.gov ID
- NCT01502007
- Acronym / sponsor ID
- 09-008672
- Conditions
- Overweight, Obesity
- Keywords
- Activity Level, Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- JR Albert Foundation
- Study start
- Apr 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 30 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accelerometer feedback and lifestyle counseling | Experimental | Other: Accelerometer feedback and lifestyle counselingThe 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 | Experimental | Other: Accelerometer without FeedbackThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerometer feedback and lifestyle counselingSubjects 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. | Other | Accelerometer feedback and lifestyle counseling |
| Accelerometer without FeedbackThe 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. | Other | Accelerometer without Feedback |
Primary outcome
Change in Activity units as determined by Accelerometry
Time frame: 6 and 12 months
9 secondary outcomes
Body weight in kilograms
Time frame: 6 and 12 months
Body fat by bone density scan (DEXA)
Time frame: 6 and 12 months
Waist to hip ratio
Time frame: 6 and 12 months
Fasting glucose
Time frame: 6 and 12 months
Hemoglobin A1c
Time frame: 6 and 12 months
Fasting insulin
Time frame: 6 and 12 months
Fasting lipid profile
Time frame: 6 and 12 months
high sensitivity c-reactive protein
Time frame: 6 and 12 months
Body Mass Index
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
- Derived from this study: PubMed 24485546Thompson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warren Thompson, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerometer feedback and lifestyle counseling and Accelerometer without Feedback in people with Overweight and Obesity, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Activity units as determined by Accelerometry (time frame: 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01502007, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2014.