ObesityIMPACTNCT01869348
IMPACT: Inactivity Monitoring and Physical Activity Controlled Trial
A study testing Monitor intervention in people with Obesity and Cardiovascular Disease, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
As individuals age, their physical activity decreases and sedentary time increases. Even small changes in these two behaviors can greatly decrease risks for several major health problems, including cardiovascular disease, diabetes, and many cancers. Read more about this study
- Who is it for?
- Ages 55 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Cardiovascular Disease, Cancer
- What is being tested?
- Monitor intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 15 Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Willing to be randomized to either group
Who cannot join
- Age below 55 or above 79
- Unable to read and understand English
- Unable to read words in standard applications on a mobile device 5 - 10" large
- Unable to find transportation to the study location
- Investigator overseeing initial fitness test does not approve participation in the study
- Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q, items 1 - 4). Reporting taking medicine for blood pressure on this questionnaire will require a doctor's note to participate.
Show all 20Show fewer
- Unable to walk for exercise (self-report)
- Report current symptoms of alcohol or substance dependence
- Plans to move away from the Galveston-Houston area or to be out of town for more than 1 week during the study period
- Unwillingness to report drugs taken for comorbidities such as hypertension or diabetes
- Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
- Participant is active (60 minutes of moderate-vigorous intensity activity per week or more)
- Participant watches little television (120 minutes per day or less)
- BMI is under 25 kg/m2 or over 35 kg/m2
- Another member of the household is a participant or staff member on this trial
- Currently a participant in a physical activity research trial
- Recently (less than six months ago) completed a physical activity research trial
- Report a history of orthopedic complications that would prevent optimal participation in the physical activities prescribed (e.g., heel spurs, severe arthritis - may be eligible, but a doctor's note will be required)
- Current smoker
- Currently uses a Jawbone Up or similar activity monitor device
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Medical Branch
Galveston, Texas, 77550
About this study
As individuals age, their physical activity decreases and sedentary time increases. Even small changes in these two behaviors can greatly decrease risks for several major health problems, including cardiovascular disease, diabetes, and many cancers. Studies that use pedometers to encourage walking have successfully increased physical activity, but do not address sedentary behaviors such as television watching. The investigators propose to use a novel pedometer-like device (Jawbone Up) that encourages both increased physical activity and decreased sedentary time. First, the investigators will recruit 10 adults to participate in a brief intervention for six weeks. They will wear the wrist-based activity monitor and use a mini-tablet device to see feedback on their activity and sedentary time. They will also receive brief counseling weekly. The investigators will use this first study to investigate the basic feasibility of the intervention materials. Next, the investigators will recruit 20 adults and randomize them to receive the intervention for 12 weeks or to a waiting list. Here, the investigators will test the intervention with refinements made based on participant responses from the first small study. Our primary outcomes will be measures of feasibility and acceptability across all parts of the study. The investigators hypothesize that the intervention will be feasible and acceptable to the participants. The investigators will also measure physical activity, sedentary behavior, fitness, body fat, and psychological feelings of motivation.
Read the detailed description
Inadequate physical activity and extended bouts of sedentary time are prevalent in adults, increasing from middle age into older adulthood. Even small changes in behavior, such as standing or walking in place periodically to break up sedentary bouts, can have large effects on cardiometabolic risk factors. Pedometer-based walking interventions have demonstrated effectiveness in increasing physical activity in this population, but these interventions have not targeted sedentary behavior. Recent technological advances have produced activity monitors that are capable of intervening on both behaviors. These wrist-worn monitors provide feedback and motivation for walking as well as cues to action in the form of idle alerts. These idle alerts vibrate when the wearer has remained sedentary for an extended period of time. Several preliminary studies have shown that older adults are willing to break up their sedentary time if prompted, but interventions thus far have relied upon television commercials as a cue to action. Use of these monitors would allow idle alerts to occur throughout the day, not only during television watching periods. The purpose of the IMPACT study (Inactivity Monitoring and Physical Activity Controlled Trial) is to investigate the feasibility of using activity monitors to simultaneously target both physical activity and sedentary behavior. First, we will conduct a pre-pilot test (N = 10) over six weeks. This brief study will provide basic feasibility and acceptability information on the monitor, content for weekly sessions, and assessments. Results will be used to refine the intervention for use in a larger pilot two-arm randomized controlled trial (N = 20, 12 weeks). This trial, comparing the intervention to a wait-list control group, will test feasibility, acceptability, and health, behavioral, and psychological outcomes. The primary outcome will be physical activity, operationalized as objectively-measured minutes of moderate-vigorous intensity physical activity over seven days (SenseWear armband). We will also measure cardiorespiratory fitness, physical function, body composition, and psychosocial variables such as autonomous motivation. The results of this innovative project will provide a foundation for future intervention in sedentary behavior and potentially create a large public health impact in a population at unique risk.
- Conditions
- Obesity, Cardiovascular Disease, Cancer, Diabetes, Sarcopenia
- Being tested
- Monitor intervention
- Keywords
- Physical activity, Activity monitor, Technology, Obesity, Aging muscle
- Medical subject headings
- Obesity, Cardiovascular Diseases, Neoplasms, Diabetes Mellitus, Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitor interventionBehavioural
Investigators will lend each participant 1 Jawbone Up activity monitor and 1 mini tablet device. Participants will receive weekly brief phone calls with counseling related to self-efficacy and self-regulation. The monitors will be programmed to provide "idle alerts" that vibrate when participants have reached a cut point for a bout of sedentary behavior (e.g., 30 minutes). Participants will monitor their progress using an app on the tablet that provides graphical feedback on physical activity and sedentary behavior.
| Study group | Role | What they receive |
|---|---|---|
| Wait list control | No intervention | This group will receive no intervention until after data collection for the randomized trial is completed. Then, they will receive the monitor intervention. |
| Monitor intervention | Experimental | This arm will receive the monitor intervention, including provision of a wristband activity monitor and mini-tablet as well as weekly counseling phone calls Receives: Behavioral: Monitor intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Activity From Baseline to 12 Weeks
Minutes of physical activity measured over a seven day period
Measured: 12 weeks
Secondary outcomes (6)
Change in Sedentary Behavior From Baseline to 12 Weeks
Minutes of total sedentary time measured over a seven day period
Measured: 12 weeks
Change in Autonomous Motivation From Baseline to 12 Weeks
We will measure feelings of autonomous and controlled motivation/regulation for physical activity
Measured: 12 weeks
Change in Physical Fitness From Baseline to 12 Weeks
We will use the six minute walk test to measure physical fitness
Measured: 12 weeks
Change in Body Composition From Baseline to 12 Weeks
We will use dual x-ray absorptiometry (DEXA) to measure body composition, including body fat percentage and lean mass
Measured: 12 weeks
Change in Physical Function From Baseline to 12 Weeks
Functional measurements will be made using the Senior Fitness Test
Measured: 12 weeks
Change in Weight From Baseline to 12 Weeks
We will measure weight (and height at baseline) using a calibrated scale
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startJun 2014
- Primary completion15 Apr 2016
- Study completion15 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth J Lyons, PhD, MPH, Principal investigator, The University of Texas Medical Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869348
- Sponsor's protocol ID
- 13-071
- Acronym
- IMPACT
- Status last verified
- May 2015
- First submitted
- 24 May 2013
- Last updated
- 4 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lewis ZH, Swartz MC, Martinez E, Lyons EJ. Social Support Patterns of Middle-Aged and Older Adults Within a Physical Activity App: Secondary Mixed Method Analysis. JMIR Aging. 2019 Aug 23;2(2):e12496. doi: 10.2196/12496.
PubMed 31518281Lyons EJ, Swartz MC, Lewis ZH, Martinez E, Jennings K. Feasibility and Acceptability of a Wearable Technology Physical Activity Intervention With Telephone Counseling for Mid-Aged and Older Adults: A Randomized Controlled Pilot Trial. JMIR Mhealth Uhealth. 2017 Mar 6;5(3):e28. doi: 10.2196/mhealth.6967.
PubMed 28264796
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT: Inactivity Monitoring and Physical Activity Controlled Trial
- ClinicalTrials.gov ID
- NCT01869348
- Acronym / sponsor ID
- IMPACT / 13-071
- Conditions
- Obesity, Cardiovascular Disease, Cancer, Diabetes, Sarcopenia
- Keywords
- Physical activity, Activity monitor, Technology, Obesity, Aging muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- 15 Apr 2016 (actual)
- Study completion
- 15 Apr 2016 (actual)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Posted 4 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As individuals age, their physical activity decreases and sedentary time increases. Even small changes in these two behaviors can greatly decrease risks for several major health problems, including cardiovascular disease, diabetes, and many cancers. Studies that use pedometers to encourage walking have successfully increased physical activity, but do not address sedentary behaviors such as television watching. The investigators propose to use a novel pedometer-like device (Jawbone Up) that encourages both increased physical activity and decreased sedentary time. First, the investigators will recruit 10 adults to participate in a brief intervention for six weeks. They will wear the wrist-based activity monitor and use a mini-tablet device to see feedback on their activity and sedentary time. They will also receive brief counseling weekly. The investigators will use this first study to investigate the basic feasibility of the intervention materials. Next, the investigators will recruit 20 adults and randomize them to receive the intervention for 12 weeks or to a waiting list. Here, the investigators will test the intervention with refinements made based on participant responses from the first small study. Our primary outcomes will be measures of feasibility and acceptability across all parts of the study. The investigators hypothesize that the intervention will be feasible and acceptable to the participants. The investigators will also measure physical activity, sedentary behavior, fitness, body fat, and psychological feelings of motivation.
Detailed description
Inadequate physical activity and extended bouts of sedentary time are prevalent in adults, increasing from middle age into older adulthood. Even small changes in behavior, such as standing or walking in place periodically to break up sedentary bouts, can have large effects on cardiometabolic risk factors. Pedometer-based walking interventions have demonstrated effectiveness in increasing physical activity in this population, but these interventions have not targeted sedentary behavior. Recent technological advances have produced activity monitors that are capable of intervening on both behaviors. These wrist-worn monitors provide feedback and motivation for walking as well as cues to action in the form of idle alerts. These idle alerts vibrate when the wearer has remained sedentary for an extended period of time. Several preliminary studies have shown that older adults are willing to break up their sedentary time if prompted, but interventions thus far have relied upon television commercials as a cue to action. Use of these monitors would allow idle alerts to occur throughout the day, not only during television watching periods. The purpose of the IMPACT study (Inactivity Monitoring and Physical Activity Controlled Trial) is to investigate the feasibility of using activity monitors to simultaneously target both physical activity and sedentary behavior. First, we will conduct a pre-pilot test (N = 10) over six weeks. This brief study will provide basic feasibility and acceptability information on the monitor, content for weekly sessions, and assessments. Results will be used to refine the intervention for use in a larger pilot two-arm randomized controlled trial (N = 20, 12 weeks). This trial, comparing the intervention to a wait-list control group, will test feasibility, acceptability, and health, behavioral, and psychological outcomes. The primary outcome will be physical activity, operationalized as objectively-measured minutes of moderate-vigorous intensity physical activity over seven days (SenseWear armband). We will also measure cardiorespiratory fitness, physical function, body composition, and psychosocial variables such as autonomous motivation. The results of this innovative project will provide a foundation for future intervention in sedentary behavior and potentially create a large public health impact in a population at unique risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait list control | No intervention | –This group will receive no intervention until after data collection for the randomized trial is completed. Then, they will receive the monitor intervention. |
| Monitor intervention | Experimental | Behavioral: Monitor interventionThis arm will receive the monitor intervention, including provision of a wristband activity monitor and mini-tablet as well as weekly counseling phone calls |
Who may qualify
- Ages
- 55 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Willing to be randomized to either group
Key exclusion criteria (20 listed)
- Age below 55 or above 79
- Unable to read and understand English
- Unable to read words in standard applications on a mobile device 5 - 10" large
- Unable to find transportation to the study location
- Investigator overseeing initial fitness test does not approve participation in the study
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 |
|---|---|---|
| Monitor interventionInvestigators will lend each participant 1 Jawbone Up activity monitor and 1 mini tablet device. Participants will receive weekly brief phone calls with counseling related to self-efficacy and self-regulation. The monitors will be programmed to provide "idle alerts" that vibrate when participants have reached a cut point for a bout of sedentary behavior (e.g., 30 minutes). Participants will monitor their progress using an app on the tablet that provides graphical feedback on physical activity and sedentary behavior. | Behavioural | Monitor intervention |
Primary outcome
Change in Physical Activity From Baseline to 12 Weeks
Time frame: 12 weeks
Minutes of physical activity measured over a seven day period
6 secondary outcomes
Change in Sedentary Behavior From Baseline to 12 Weeks
Time frame: 12 weeks
Change in Autonomous Motivation From Baseline to 12 Weeks
Time frame: 12 weeks
Change in Physical Fitness From Baseline to 12 Weeks
Time frame: 12 weeks
Change in Body Composition From Baseline to 12 Weeks
Time frame: 12 weeks
Change in Physical Function From Baseline to 12 Weeks
Time frame: 12 weeks
Change in Weight From Baseline to 12 Weeks
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31518281Lewis ZH, Swartz MC, Martinez E, Lyons EJ. Social Support Patterns of Middle-Aged and Older Adults Within a Physical Activity App: Secondary Mixed Method Analysis. JMIR Aging. 2019 Aug 23;2(2):e12496. doi: 10.2196/12496.
- Derived from this study: PubMed 28264796Lyons EJ, Swartz MC, Lewis ZH, Martinez E, Jennings K. Feasibility and Acceptability of a Wearable Technology Physical Activity Intervention With Telephone Counseling for Mid-Aged and Older Adults: A Randomized Controlled Pilot Trial. JMIR Mhealth Uhealth. 2017 Mar 6;5(3):e28. doi: 10.2196/mhealth.6967.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Elizabeth J Lyons, PhD, MPH principal investigator
The University of Texas Medical Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitor intervention in people with Obesity and Cardiovascular Disease, run by The University of Texas Medical Branch, Galveston 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 1 inclusion and 20 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 4 Oct 2017. 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?
Yes. Results are posted in the registry (first posted 4 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Physical Activity From Baseline to 12 Weeks (time frame: 12 weeks). 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 NCT01869348, which also lists 2 linked publications.
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 4 Oct 2017.