Body Weight ChangesLEANNCT00957008
Lifestyle Education for Activity and Nutrition for a Leaner You
A study testing Group weight loss program, Group weight loss program plus use of the Senseware Armband and Use of the senseware armband alone program in people with Body Weight Changes and Overweight, run by University of South Carolina at 1 site in United States.
Trial summary
Although weight loss programs are effective in the short-term, maintaining weight loss is more challenging. Regularly tracking and logging physical activity (PA) and diet is related to greater improvements in PA and diet and to greater weight loss over time. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight Changes, Overweight
- What is being tested?
- Group weight loss program, Group weight loss program plus use of the Senseware Armband and Use of the senseware armband alone program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Dec 2009
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years older men \& women
- Body mass index 25.0-39.9
- Ability to provide informed consent
Who cannot join
- Type I Diabetes
- Type II diabetes taking insulin
- Surgery or Hospitalization in last year (unless minor outpatient surgery)
- Blood pressure >159/94
- Cancer (other than non-melanoma skin cancer) in last 5 years
- History of bariatric surgery
Show all 23Show fewer
- Current treatment with herbal, over-the-counter, or prescription weight loss drugs
- Current treatment with ant-metabolite medications or other medications that affect weight
- Current pregnancy or breastfeeding, or plans pregnancy in next 18 months gastrointestinal disorders including ulcerative colitis, Crohn's disease, malabsorption syndromes)
- Chronic renal insufficiency
- Chronic liver disease
- History of anorexia nervosa, bulimia, laxative abuse
- Current alcohol or substance abuse
- Chronic heart failure, New York Heart Association Class III or IV
- Uncontrolled arrythmia
- Uncontrolled hyper- or hypothyroidism
- Large weight loss of 20 or more kilograms in the past year
- Hospitalization for mental illness within the past 5 years or currently undergoing treatment for severe mental illness
- Center for Epidemiologic Studies Depression Scale Score ≥ 16
- Musculoskeletal problems interfering with exercise.
- Autoimmune or collagen vascular diseases.
- Immunodeficiency diseases or a positive Human immunodeficiency virus test
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina Department of Exercise Science
Columbia, South Carolina, 29208
About this study
Official title: Use of Electronic Feedback on Diet and Physical Activity to Enhance Weight Management
Although weight loss programs are effective in the short-term, maintaining weight loss is more challenging. Regularly tracking and logging physical activity (PA) and diet is related to greater improvements in PA and diet and to greater weight loss over time. Receiving continuous real-time feedback regarding calories burned and calories consumed could enhance weight loss maintenance. This study will examine whether a device that provides such feedback, called the SenseWear armband, enhances weight maintenance.
200 overweight adults aged 18 to 65 years will be randomly assigned to one of four groups: (1) a standard behavior change weight loss group-based program (14 group sessions over a 4 month period followed by 6 phone calls over a 5 month period), (2) a standard behavior change weight loss group-based program (15 group session over a 4 month period followed by 6 phone calls over a 5 month period) combined with the armband, (3) the armband alone (training in the use of the armband and a follow up telephone call), or (4) a self-directed weight loss control group.
Participants will be recruited through USC through listserv emails, flyers, and worksite advertisements. Interested individuals will take part in a telephone screen, an orientation, a run-in visit (which includes 2 weeks of PA and dietary logging), a baseline assessment, and a randomization visit. The intervention will then take place over a 9-month period with eligible participants. Participants will take part in follow-up assessments at month 4 and 9. Assessments at all three times will include questionnaires assessing diet, PA, psychosocial factors related to diet and PA, and quality of life related measures. They will also have their fasting blood drawn to assess lipids, glucose, and insulin, and staff will measure their blood pressure, waist circumference (size), skinfold, height, and weight.
Read the detailed description
Use of Electronic Feedback on Diet and Physical Activity to Enhance Weight Management Research Summary Steven N. Blair, PED, Principal Investigator
Primary Aim
Dr. Blair and the investigative team will evaluate the contribution of the BodyMedia metabolic monitoring system to weight loss within the context of a standard behavioral weight loss program, and also as a stand alone system. The BodyMedia system consists of a metabolic monitor (armband) and computer software that analyzes energy expenditure, duration and level of physical activity, and other metabolic processes in free-living conditions. The proposed study will test the following hypotheses:
- The standard behavioral weight loss program (Standard), BodyMedia augmented program (Armband), and the Armband Alone will produce more weight loss and reduction in waist circumference over 4 months and maintain greater weight loss and reduction in waist circumference than does a usual care self-help program (Usual Care).
- The Armband program will produce weight loss and reduction in waist circumference comparable to the Standard program over 4 months.
- The Armband Alone program will produce weight loss and reduction in waist circumference comparable to the Standard program after 9 months.
- The Armband program will produce weight loss and reduction in waist circumference greater than the Standard program after 9 months.
Primary Outcomes
- Body weight
- Waist circumference
Secondary Outcomes
- Weekly energy expenditure in physical activity.
- Weekly caloric intake.
- Percent of participants losing ≥5% of baseline body weight.
- Stages of Motivational Readiness for physical activity and diet changes.
Tertiary Outcomes
- Blood pressure.
- Fasting lipid profile.
- Fasting blood glucose.
- Fasting blood insulin
- Quality of life.
Study Design
The design will be a randomized controlled trial with four arms:
- Standard behavioral weight loss intervention program.
- Armband (standard behavioral weight loss intervention program augmented by using the BodyMedia armband and monitoring system to reinforce and support making changes in these behaviors).
- Armband Alone that includes a one-hour orientation at baseline on how to use the armband, with a one week follow-up telephone call to answer questions.
- Usual care (self-help with a diet and physical activity manual that provides guidance on changing these behaviors).
Fifty participants will be assigned to each of the study arms. The Standard and Armband groups will participate in weekly group counseling sessions for four months. During months 5-7 study staff will contact participants weekly via email or telephone to monitor their reports of dietary and physical activity logging, and to provide counseling support as necessary. During months 8 and 9, these contacts will be monthly. For the Armband Alone group, study staff will make monthly contact by telephone or email to answer questions and provide encouragement.
Data collection for outcomes will occur at baseline, 4 months (no blood chemistry analyses will be performed at 4 months), and 9 months. Participants will be recruited into the study over several months, and all participants will have completed the follow-up (month 9) data collection by the end of the 18-month study period.
- Conditions
- Body Weight Changes, Overweight
- Being tested
- Group weight loss program, Group weight loss program plus use of the Senseware Armband, Use of the senseware armband alone program
- Medical subject headings
- Body Weight Changes, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group weight loss programBehavioural
Also called Standard bahavior weight loss
Participants will be asked to attend 14 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 16 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a weight loss manual.
Group weight loss program plus use of the Senseware ArmbandOther
Also called Standard behavioral weight loss plus Armband
Participants will be asked to attend 15 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 17 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a SenseWear Armband to wear during their 6 months in the program. One of these group sessions will be devoted to learning how to use the SenseWear Armband. They will be asked to wear the Armband regularly, upload data from the Armband to a web-based application, and input nutritional and health information into a personalized web account. They will receive a weight loss manual in addition to the group sessions and Armband.
Use of the senseware armband alone programDevice
Also called Armband Alone
Participants will be asked to attend a one-hour group session at the University of South Carolina's Public Health Research Center (PHRC) to learn how to use the SenseWear Armband. They will then be asked to take part in a follow-up telephone call one week after they start wearing the armband. For the 6 months they are in the program, they will be asked to wear the Armband regularly, upload data from the Armband to a web-based application, and input nutritional and health information into a personalized web account. They will also receive a weight loss manual in addition to the Armband.
| Study group | Role | What they receive |
|---|---|---|
| A - GWL | Experimental | Group Weight Loss Program (GWL) - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator. Receives: Behavioral: Group weight loss program |
| B - GWL+SWA | Experimental | Group weight loss program plus use of the Senseware Armband - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator and wore a SenseWear Armband. The SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day. Receives: Other: Group weight loss program plus use of the Senseware Armband |
| C - SWA Alone | Experimental | Use of the senseware armband alone program - The intervention for the SWA Alone group was the SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day. Receives: Device: Use of the senseware armband alone program |
| D - Standard Care | No intervention | Standard Care - Participants in this group received a self-directed weight loss manual that focused on cognitive and behavior change principles and learning activities based on Active Living Every Day and Healthy Eating Every Day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist Circumference
Waist circumference was measured at the level of the umbilicus with a plastic tape measure.
Measured: Month 9
Body Weight
Body weight was assessed using a calibrated balance-beam scale.
Measured: nine month
Body Weight
Measured: 4 month
Waist Circumference
Measured: 4 month
Secondary outcomes (1)
Blood Fasting Glucose
Measured: Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startFeb 2008
- Primary completionDec 2009
- Study completionDec 2009
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 (1)Papers the sponsor has linked to this study.
- Other trials for Body Weight ChangesStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven N. Blair, University of South Carolina
- Investigators
- Steven N Blair, PED, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957008
- Sponsor's protocol ID
- Pro00005091
- Acronym
- LEAN
- Status last verified
- Apr 2019
- First submitted
- 7 Aug 2009
- Last updated
- 19 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Shuger SL, Barry VW, Sui X, McClain A, Hand GA, Wilcox S, Meriwether RA, Hardin JW, Blair SN. Electronic feedback in a diet- and physical activity-based lifestyle intervention for weight loss: a randomized controlled trial. Int J Behav Nutr Phys Act. 2011 May 18;8:41. doi: 10.1186/1479-5868-8-41.
PubMed 21592351
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Electronic Feedback on Diet and Physical Activity to Enhance Weight Management
- ClinicalTrials.gov ID
- NCT00957008
- Acronym / sponsor ID
- LEAN / Pro00005091
- Conditions
- Body Weight Changes, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 11 Aug 2009 (estimated)
- Results
- Posted 23 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although weight loss programs are effective in the short-term, maintaining weight loss is more challenging. Regularly tracking and logging physical activity (PA) and diet is related to greater improvements in PA and diet and to greater weight loss over time. Receiving continuous real-time feedback regarding calories burned and calories consumed could enhance weight loss maintenance. This study will examine whether a device that provides such feedback, called the SenseWear armband, enhances weight maintenance.
200 overweight adults aged 18 to 65 years will be randomly assigned to one of four groups: (1) a standard behavior change weight loss group-based program (14 group sessions over a 4 month period followed by 6 phone calls over a 5 month period), (2) a standard behavior change weight loss group-based program (15 group session over a 4 month period followed by 6 phone calls over a 5 month period) combined with the armband, (3) the armband alone (training in the use of the armband and a follow up telephone call), or (4) a self-directed weight loss control group.
Participants will be recruited through USC through listserv emails, flyers, and worksite advertisements. Interested individuals will take part in a telephone screen, an orientation, a run-in visit (which includes 2 weeks of PA and dietary logging), a baseline assessment, and a randomization visit. The intervention will then take place over a 9-month period with eligible participants. Participants will take part in follow-up assessments at month 4 and 9. Assessments at all three times will include questionnaires assessing diet, PA, psychosocial factors related to diet and PA, and quality of life related measures. They will also have their fasting blood drawn to assess lipids, glucose, and insulin, and staff will measure their blood pressure, waist circumference (size), skinfold, height, and weight.
Detailed description
Use of Electronic Feedback on Diet and Physical Activity to Enhance Weight Management Research Summary Steven N. Blair, PED, Principal Investigator
Primary Aim
Dr. Blair and the investigative team will evaluate the contribution of the BodyMedia metabolic monitoring system to weight loss within the context of a standard behavioral weight loss program, and also as a stand alone system. The BodyMedia system consists of a metabolic monitor (armband) and computer software that analyzes energy expenditure, duration and level of physical activity, and other metabolic processes in free-living conditions. The proposed study will test the following hypotheses:
- The standard behavioral weight loss program (Standard), BodyMedia augmented program (Armband), and the Armband Alone will produce more weight loss and reduction in waist circumference over 4 months and maintain greater weight loss and reduction in waist circumference than does a usual care self-help program (Usual Care).
- The Armband program will produce weight loss and reduction in waist circumference comparable to the Standard program over 4 months.
- The Armband Alone program will produce weight loss and reduction in waist circumference comparable to the Standard program after 9 months.
- The Armband program will produce weight loss and reduction in waist circumference greater than the Standard program after 9 months.
Primary Outcomes
- Body weight
- Waist circumference
Secondary Outcomes
- Weekly energy expenditure in physical activity.
- Weekly caloric intake.
- Percent of participants losing ≥5% of baseline body weight.
- Stages of Motivational Readiness for physical activity and diet changes.
Tertiary Outcomes
- Blood pressure.
- Fasting lipid profile.
- Fasting blood glucose.
- Fasting blood insulin
- Quality of life.
Study Design
The design will be a randomized controlled trial with four arms:
- Standard behavioral weight loss intervention program.
- Armband (standard behavioral weight loss intervention program augmented by using the BodyMedia armband and monitoring system to reinforce and support making changes in these behaviors).
- Armband Alone that includes a one-hour orientation at baseline on how to use the armband, with a one week follow-up telephone call to answer questions.
- Usual care (self-help with a diet and physical activity manual that provides guidance on changing these behaviors).
Fifty participants will be assigned to each of the study arms. The Standard and Armband groups will participate in weekly group counseling sessions for four months. During months 5-7 study staff will contact participants weekly via email or telephone to monitor their reports of dietary and physical activity logging, and to provide counseling support as necessary. During months 8 and 9, these contacts will be monthly. For the Armband Alone group, study staff will make monthly contact by telephone or email to answer questions and provide encouragement.
Data collection for outcomes will occur at baseline, 4 months (no blood chemistry analyses will be performed at 4 months), and 9 months. Participants will be recruited into the study over several months, and all participants will have completed the follow-up (month 9) data collection by the end of the 18-month study period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A - GWL | Experimental | Behavioral: Group weight loss programGroup Weight Loss Program (GWL) - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator. |
| B - GWL+SWA | Experimental | Other: Group weight loss program plus use of the Senseware ArmbandGroup weight loss program plus use of the Senseware Armband - Participants in this group attended a 14-session group weight loss program administered by trained facilitators plus 6 one-on-one telephone sessions with a facilitator and wore a SenseWear Armband. The SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day. |
| C - SWA Alone | Experimental | Device: Use of the senseware armband alone programUse of the senseware armband alone program - The intervention for the SWA Alone group was the SenseWear system includes the Armband, a real-time display device, and a personalized Weight Management Solutions web account. Participants received training in using the Armband and were asked to wear it at least 16 hours per day. |
| D - Standard Care | No intervention | –Standard Care - Participants in this group received a self-directed weight loss manual that focused on cognitive and behavior change principles and learning activities based on Active Living Every Day and Healthy Eating Every Day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years older men \& women
- Body mass index 25.0-39.9
- Ability to provide informed consent
Key exclusion criteria (23 listed)
- Type I Diabetes
- Type II diabetes taking insulin
- Surgery or Hospitalization in last year (unless minor outpatient surgery)
- Blood pressure >159/94
- Cancer (other than non-melanoma skin cancer) in last 5 years
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 |
|---|---|---|
| Group weight loss programAlso: Standard bahavior weight lossParticipants will be asked to attend 14 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 16 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a weight loss manual. | Behavioural | A - GWL |
| Group weight loss program plus use of the Senseware ArmbandAlso: Standard behavioral weight loss plus ArmbandParticipants will be asked to attend 15 one-and-half-hour group sessions at the University of South Carolina's Public Health Research Center (PHRC) over a 17 week period. After the groups end, they will be asked to take part in 6 telephone calls during their remaining 2 months in the program. They will also receive a SenseWear Armband to wear during their 6 months in the program. One of these group sessions will be devoted to learning how to use the SenseWear Armband. They will be asked to wear the Armband regularly, upload data from the Armband to a web-based application, and input nutritional and health information into a personalized web account. They will receive a weight loss manual in addition to the group sessions and Armband. | Other | B - GWL+SWA |
| Use of the senseware armband alone programAlso: Armband AloneParticipants will be asked to attend a one-hour group session at the University of South Carolina's Public Health Research Center (PHRC) to learn how to use the SenseWear Armband. They will then be asked to take part in a follow-up telephone call one week after they start wearing the armband. For the 6 months they are in the program, they will be asked to wear the Armband regularly, upload data from the Armband to a web-based application, and input nutritional and health information into a personalized web account. They will also receive a weight loss manual in addition to the Armband. | Device | C - SWA Alone |
Primary outcome
Waist Circumference
Time frame: Month 9
Waist circumference was measured at the level of the umbilicus with a plastic tape measure.
Body Weight
Time frame: nine month
Body weight was assessed using a calibrated balance-beam scale.
Body Weight
Time frame: 4 month
Waist Circumference
Time frame: 4 month
1 secondary outcome
Blood Fasting Glucose
Time frame: Month 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21592351Shuger SL, Barry VW, Sui X, McClain A, Hand GA, Wilcox S, Meriwether RA, Hardin JW, Blair SN. Electronic feedback in a diet- and physical activity-based lifestyle intervention for weight loss: a randomized controlled trial. Int J Behav Nutr Phys Act. 2011 May 18;8:41. doi: 10.1186/1479-5868-8-41.
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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.
Steven N Blair, PED principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group weight loss program, Group weight loss program plus use of the Senseware Armband and Use of the senseware armband alone program in people with Body Weight Changes and Overweight, run by University of South Carolina 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 3 inclusion and 23 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 19 Apr 2019. 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 23 Mar 2011). 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?
Waist Circumference (time frame: Month 9). The study lists 4 primary outcomes in all. 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 NCT00957008, 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 19 Apr 2019.