ObesityB-MOBILENCT02160834
Reducing Sedentary Time in Obese Adults (Study 2)
A study testing B-MOBILE Smartphone-Based Intervention (3-min break) and B-MOBILE Smartphone-Based Intervention (6-min break) in people with Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
Greater time spent in sedentary behaviors, independent of physical activity level, can increase risk of morbidity and mortality. Objective assessments indicate that bariatric surgery patients spend large amounts of time in sedentary behaviors. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- B-MOBILE Smartphone-Based Intervention (3-min break) and B-MOBILE Smartphone-Based Intervention (6-min break)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2014
- 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Bariatric surgery patients and other obese individuals will be considered
- Body mass index >= 25 kg/m2
Who cannot join
- Report being unable to engage in daily activities and walk continuously for >= 10 minutes without assistance
- Are currently involved in a physical activity intervention.
- Are unable to read or understand the study materials
- Are currently taking medications that cause dizziness and/or feeling faint when sitting or standing.
- Report any condition that in the opinion of investigators would preclude adherence to the intervention protocol including plans to relocate, history of substance abuse or other significant psychiatric problems, or terminal illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
About this study
Official title: A Mobile Health Approach to Reducing Sedentary Time in Bariatric Surgery Patients
Greater time spent in sedentary behaviors, independent of physical activity level, can increase risk of morbidity and mortality. Objective assessments indicate that bariatric surgery patients spend large amounts of time in sedentary behaviors. The present study is the first to test whether a mobile health (mHealth) approach that employs widely adopted smartphone technology to monitor and modify sedentary behaviors as they occur is a feasible and acceptable method of reducing sedentary time in these patients and other obese populations.
- Conditions
- Obesity
- Being tested
- B-MOBILE Smartphone-Based Intervention (3-min break), B-MOBILE Smartphone-Based Intervention (6-min break)
- Keywords
- Sedentary behavior, Physical activity, Obesity, Mobile health, Smartphone, Time spent sedentary
- Medical subject headings
- Obesity, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-MOBILE Smartphone-Based Intervention (3-min break)Behavioural
Participants will receive a smartphone with B-MOBILE app that automatically monitors their sedentary time and prompts them after every 30 continuous sedentary minutes to walk for at least 3 minutes. Participants who meet this goal will receive reinforcing feedback in "real time."
B-MOBILE Smartphone-Based Intervention (6-min break)Behavioural
Participants will receive a smartphone with B-MOBILE app that automatically monitors their sedentary time and prompts them after every 60 continuous sedentary minutes to walk for at least 6 minutes. Participants who meet this goal will receive reinforcing feedback in "real time."
| Study group | Role | What they receive |
|---|---|---|
| B-MOBILE smartphone-based intervention (3-min break) | Experimental | Participants will receive a smartphone with B-MOBILE app that automatically monitors their sedentary time and prompts them after every 30 continuous sedentary minutes to walk for at least 3 minutes. Participants who meet this goal will receive reinforcing feedback in "real time." Receives: Behavioral: B-MOBILE Smartphone-Based Intervention (3-min break) |
| B-MOBILE Smartphone-Based Intervention (6-min break) | Experimental | Participants will receive a smartphone with B-MOBILE app that automatically monitors their sedentary time and prompts them after every 60 continuous sedentary minutes to walk for at least 6 minutes. Participants who meet this goal will receive reinforcing feedback in "real time." Receives: Behavioral: B-MOBILE Smartphone-Based Intervention (6-min break) |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percentage of daily sedentary time from baseline to post-intervention.
Measured: 8 weeks
Secondary outcomes (1)
Change in percentage of daily sedentary time from baseline to follow-up
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 posted11 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: study not initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dale S Bond, PhD, Principal investigator, The Miriam Hospital/Brown Alpert Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160834
- Sponsor's protocol ID
- 1R03KD095740-02
- Other IDs
- R03DK095740
- Acronym
- B-MOBILE
- Status last verified
- Jun 2014
- First submitted
- 9 Jun 2014
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Health Approach to Reducing Sedentary Time in Bariatric Surgery Patients
- ClinicalTrials.gov ID
- NCT02160834
- Acronym / sponsor ID
- B-MOBILE / 1R03KD095740-02
- Conditions
- Obesity
- Keywords
- Sedentary behavior, Physical activity, Obesity, Mobile health, Smartphone, Time spent sedentary
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study not initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Jun 2014 (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.
Greater time spent in sedentary behaviors, independent of physical activity level, can increase risk of morbidity and mortality. Objective assessments indicate that bariatric surgery patients spend large amounts of time in sedentary behaviors. The present study is the first to test whether a mobile health (mHealth) approach that employs widely adopted smartphone technology to monitor and modify sedentary behaviors as they occur is a feasible and acceptable method of reducing sedentary time in these patients and other obese populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| B-MOBILE smartphone-based intervention (3-min break) | Experimental | Behavioral: B-MOBILE Smartphone-Based Intervention (3-min break)Participants will receive a smartphone with B-MOBILE app that automatically monitors their sedentary time and prompts them after every 30 continuous sedentary minutes to walk for at least 3 minutes. Participants who meet this goal will receive reinforcing feedback in "real time." |
| B-MOBILE Smartphone-Based Intervention (6-min break) | Experimental | Behavioral: B-MOBILE Smartphone-Based Intervention (6-min break)Participants will receive a smartphone with B-MOBILE app that automatically monitors their sedentary time and prompts them after every 60 continuous sedentary minutes to walk for at least 6 minutes. Participants who meet this goal will receive reinforcing feedback in "real time." |
| Control | No intervention | – |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Bariatric surgery patients and other obese individuals will be considered
- Body mass index >= 25 kg/m2
Key exclusion criteria (5 listed)
- Report being unable to engage in daily activities and walk continuously for >= 10 minutes without assistance
- Are currently involved in a physical activity intervention.
- Are unable to read or understand the study materials
- Are currently taking medications that cause dizziness and/or feeling faint when sitting or standing.
- Report any condition that in the opinion of investigators would preclude adherence to the intervention protocol including plans to relocate, history of substance abuse or other significant psychiatric problems, or terminal illness.
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 |
|---|---|---|
| B-MOBILE Smartphone-Based Intervention (3-min break)Participants will receive a smartphone with B-MOBILE app that automatically monitors their sedentary time and prompts them after every 30 continuous sedentary minutes to walk for at least 3 minutes. Participants who meet this goal will receive reinforcing feedback in "real time." | Behavioural | B-MOBILE smartphone-based intervention (3-min break) |
| B-MOBILE Smartphone-Based Intervention (6-min break)Participants will receive a smartphone with B-MOBILE app that automatically monitors their sedentary time and prompts them after every 60 continuous sedentary minutes to walk for at least 6 minutes. Participants who meet this goal will receive reinforcing feedback in "real time." | Behavioural | B-MOBILE Smartphone-Based Intervention (6-min break) |
Primary outcome
Change in percentage of daily sedentary time from baseline to post-intervention.
Time frame: 8 weeks
1 secondary outcome
Change in percentage of daily sedentary time from baseline to follow-up
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
Related trials for Obesity
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
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.
Dale S Bond, PhD principal investigator
The Miriam Hospital/Brown Alpert Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-MOBILE Smartphone-Based Intervention (3-min break) and B-MOBILE Smartphone-Based Intervention (6-min break) in people with Obesity, run by The Miriam Hospital 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 2 inclusion and 5 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: withdrawn, as of the sponsor's last update on 24 Mar 2015. 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 was withdrawn before enrolling participants, so there are no results.
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 percentage of daily sedentary time from baseline to post-intervention. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2015.