ObesityNCT01537796
Comparison of a Technology-based System and an In-person Behavioral Weight Loss Intervention in the Severely Obese
A study testing In-Person weight loss, FIT weight loss and FIT-BT weight loss in people with Obesity, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to examine the effect of an enhanced technology-based system, that involves a wearable device to measure calories burned combined with a website, in comparison to previous versions of similar technology and a standard behavioral weight loss on body weight across 6 months in obese adults. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- In-Person weight loss, FIT weight loss and FIT-BT weight loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jul 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 21-55 years of age
- Body mass index (BMI) between 35.0-45.0 kg/m2
Who cannot join
- Reports not having access to a computer, access to the Internet, or the availability to download software onto a computer.
- Reports not having a smart phone device that is compatible with the BodyMedia® FIT Bluetooth® System that will be examined in this study.
- Has a physical limitation that would prevent engaging in physical activity.
- Participates in structured aerobic exercise for ≥ 60 minutes per week over the prior ≥ 3 months.
- Reports being treated for a current medical condition that could affect body weight. These may include the following: cancer; diabetes mellitus; hyperthyroidism; inadequately controlled hypothyroidism; chronic renal insufficiency; chronic liver disease; gastrointestinal disorders including ulcerative colitis, Crohn's disease, or malabsorption syndromes, etc.
- Reports current congestive heart failure, angina, uncontrolled arrhythmia, symptoms indicative of increase risk of an acute cardiovascular event, coronary artery bypass grafting or angioplasty, prior myocardial infarction, and conditions requiring anticoagulation therapy (i.e. deep vein thrombosis).
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- Has a resting systolic blood pressure ≥ 150 mmHg or resting diastolic blood pressure of ≥ 100 mmHg or taking medications to control blood pressure.
- Being treated for any psychological issues (i.e., depression, bipolar disorder, etc) or taking psychotropic medications within the previous 12 months.
- Taking prescription or over-the-counter medications that affect body weight and metabolism.
- Has lost > 5% of current body weight in the past 3 months and maintained this weight loss at the time of recruitment for this study.
- Currently participating in an exercise or weight control study, had participated in an exercise or weight control study within the previous 6 months, or a current participant in a commercial weight reduction program.
- Has undergone bariatric surgery (e.g., gastric bypass, lap-band) for weight loss.
- Currently being treated for an eating disorder.
- Currently pregnant, pregnant in the last 6 months, breast feeding in the last 3 months, lactating, to planning on becoming pregnant in the next 3 months.
- Planning on relocating outside of the greater Pittsburgh area within the next 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
The purpose of this study is to examine the effect of an enhanced technology-based system, that involves a wearable device to measure calories burned combined with a website, in comparison to previous versions of similar technology and a standard behavioral weight loss on body weight across 6 months in obese adults.
Read the detailed description
The primary aim of this study is to compare changes in body weight between an in-person behavioral weight loss program, a technology-based system, and an enhanced version of a technology-based system during a 6 month behavioral weight loss intervention in obese adults. Additional aims will compare changes in body composition, physical activity, dietary intake, and the frequency of self-monitoring of weight loss behaviors between the 3 groups. A total of 84 sedentary, healthy obese adults (BMI: 35.0-45.0 kg/m2) between the ages of 21-55 will be recruited to participate. Assessments will be conducted at 0, 3, and 6 months and will include measurements of height, weight, body composition, blood pressure, physical activity, dietary intake, and eating behaviors. This is a randomized controlled trial in which participants will be randomized after the completion of assessments to one of three groups: standard behavioral weight loss (SBWL), BodyMedia® FIT System (FIT), and BodyMedia® FIT System with Bluetooth® enhancements (FIT-BT). Subjects in SBWL will participate in a behavioral weight loss intervention which includes weekly group sessions throughout the 6 month program. FIT and FIT-BT will not attend weekly group sessions, but will have identical intervention materials mailed each week. FIT will receive the BodyMedia® FIT System, and FIT-BT will receive the BodyMedia® FIT System with Bluetooth® enhancements to use throughout the 6 month program. FIT and FIT-BT will receive a telephone intervention call 1x per month.
- Conditions
- Obesity
- Being tested
- In-Person weight loss, FIT weight loss, FIT-BT weight loss
- Keywords
- Obesity, Exercise
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Person weight lossBehavioural
Participants will attend weekly group intervention meetings. These sessions will address barriers associated with altering physical activity participation and dietary intake. Group discussions will be facilitated by the interventionist and interactive participation will be encouraged. Participants will be provided with written materials at each meeting to supplement group discussions. Paper diaries will be provided each week to assist participants with self-monitoring of calorie and fat consumption, and physical activity minutes and intensity. Participants will return the diary to the intervention staff each week for review and constructive feedback.
FIT weight lossBehavioural
Intervention materials will be provided and mailed weekly to participants. Participants will be provided with the BodyMedia® FIT System that includes a wearable device to monitor physical activity and energy expenditure, a display device to provide feedback on achievement of energy expenditure and physical activity goals, and web-based software to assist with self-monitoring of dietary intake and to provide feedback on goal achievement. Participants will attend one introductory session in which a tutorial of the components of the enhanced FIT System will be provided. Participants will receive a one-hour lesson on basic guidelines of the weight loss intervention. Once per month participants will receive a scheduled 10 minute intervention telephone call with the intervention staff.
FIT-BT weight lossBehavioural
Participants will be provided with intervention materials that are mailed weekly to them. Participants will be provided with the enhanced BodyMedia® FIT System that includes a wearable device with Bluetooth® technology to allow participants to receive real-time feedback on calories expended and physical activity on their smart phone. This also supports self-monitoring of dietary behaviors and body weight. Participants will attend one introductory session in which a tutorial of the components of the enhanced FIT System will be provided. Participants will also receive a one-hour lesson on basic guidelines of the weight loss intervention. Once per month participants will receive a scheduled 10 minute intervention telephone call with the intervention staff.
| Study group | Role | What they receive |
|---|---|---|
| In-Person weight loss | Experimental | Participants will attend weekly group intervention meetings. These sessions will address barriers associated with altering physical activity participation and dietary intake. Group discussions will be facilitated by the interventionist and interactive participation will be encouraged. Participants will be provided with written materials at each meeting to supplement group discussions. Paper diaries will be provided each week to assist participants with self-monitoring of calorie and fat consumption, and physical activity minutes and intensity. Participants will return the diary to the intervention staff each week for review and constructive feedback. Receives: Behavioral: In-Person weight loss |
| FIT weight loss | Experimental | Intervention materials will be provided and mailed weekly to participants. Participants will be provided with the BodyMedia® FIT System that includes a wearable device to monitor physical activity and energy expenditure, a display device to provide feedback on achievement of energy expenditure and physical activity goals, and web-based software to assist with self-monitoring of dietary intake and to provide feedback on goal achievement. Participants will attend one introductory session in which a tutorial of the components of the enhanced FIT System will be provided. Participants will receive a one-hour lesson on basic guidelines of the weight loss intervention. Once per month participants will receive a scheduled 10 minute intervention telephone call with the intervention staff. Receives: Behavioral: FIT weight loss |
| FIT-BT weight loss | Experimental | Participants will be provided with intervention materials that are mailed weekly to them. Participants will be provided with the enhanced BodyMedia® FIT System that includes a wearable device with Bluetooth® technology to allow participants to receive real-time feedback on calories expended and physical activity on their smart phone. This also supports self-monitoring of dietary behaviors and body weight. Participants will attend one introductory session in which a tutorial of the components of the enhanced FIT System will be provided. Participants will also receive a one-hour lesson on basic guidelines of the weight loss intervention. Once per month participants will receive a scheduled 10 minute intervention telephone call with the intervention staff. Receives: Behavioral: FIT-BT weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (5)
Change in body composition
Measured: Baseline, 3 months, and 6 months
Change in moderate-to-vigorous intensity physical activity
Measured: Baseline, 3 months, and 6 months
Change in dietary intake
Measured: Baseline, 3 months, and 6 months
Completion of self-monitoring of eating behavior
The frequency that participants engaged in the self-monitoring of eating behavior as measured by either completion of an eating diary or the use of the BodyMedia Fit system software.
Measured: Baseline to 6 months
Frequency of self-monitoring of physical activity behavior
The frequency that participants engaged in the self-monitoring of physical activity as measured by either completion of an exercise diary or the use of the BodyMedia Fit system.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2013
- Study completionJul 2013
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.
- More trials run by University of PittsburghThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John M. Jakicic, PhD, University of Pittsburgh
- Investigators
- John M Jakicic, PhD, Principal investigator, University of PittsburghRenee J Rogers, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537796
- Sponsor's protocol ID
- PRO11120127
- Status last verified
- Aug 2015
- First submitted
- 15 Feb 2012
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Technology-based System and an In-person Behavioral Weight Loss Intervention in the Severely Obese
- ClinicalTrials.gov ID
- NCT01537796
- Acronym / sponsor ID
- PRO11120127
- Conditions
- Obesity
- Keywords
- Obesity, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 23 Feb 2012 (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 purpose of this study is to examine the effect of an enhanced technology-based system, that involves a wearable device to measure calories burned combined with a website, in comparison to previous versions of similar technology and a standard behavioral weight loss on body weight across 6 months in obese adults.
Detailed description
The primary aim of this study is to compare changes in body weight between an in-person behavioral weight loss program, a technology-based system, and an enhanced version of a technology-based system during a 6 month behavioral weight loss intervention in obese adults. Additional aims will compare changes in body composition, physical activity, dietary intake, and the frequency of self-monitoring of weight loss behaviors between the 3 groups. A total of 84 sedentary, healthy obese adults (BMI: 35.0-45.0 kg/m2) between the ages of 21-55 will be recruited to participate. Assessments will be conducted at 0, 3, and 6 months and will include measurements of height, weight, body composition, blood pressure, physical activity, dietary intake, and eating behaviors. This is a randomized controlled trial in which participants will be randomized after the completion of assessments to one of three groups: standard behavioral weight loss (SBWL), BodyMedia® FIT System (FIT), and BodyMedia® FIT System with Bluetooth® enhancements (FIT-BT). Subjects in SBWL will participate in a behavioral weight loss intervention which includes weekly group sessions throughout the 6 month program. FIT and FIT-BT will not attend weekly group sessions, but will have identical intervention materials mailed each week. FIT will receive the BodyMedia® FIT System, and FIT-BT will receive the BodyMedia® FIT System with Bluetooth® enhancements to use throughout the 6 month program. FIT and FIT-BT will receive a telephone intervention call 1x per month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In-Person weight loss | Experimental | Behavioral: In-Person weight lossParticipants will attend weekly group intervention meetings. These sessions will address barriers associated with altering physical activity participation and dietary intake. Group discussions will be facilitated by the interventionist and interactive participation will be encouraged. Participants will be provided with written materials at each meeting to supplement group discussions. Paper diaries will be provided each week to assist participants with self-monitoring of calorie and fat consumption, and physical activity minutes and intensity. Participants will return the diary to the intervention staff each week for review and constructive feedback. |
| FIT weight loss | Experimental | Behavioral: FIT weight lossIntervention materials will be provided and mailed weekly to participants. Participants will be provided with the BodyMedia® FIT System that includes a wearable device to monitor physical activity and energy expenditure, a display device to provide feedback on achievement of energy expenditure and physical activity goals, and web-based software to assist with self-monitoring of dietary intake and to provide feedback on goal achievement. Participants will attend one introductory session in which a tutorial of the components of the enhanced FIT System will be provided. Participants will receive a one-hour lesson on basic guidelines of the weight loss intervention. Once per month participants will receive a scheduled 10 minute intervention telephone call with the intervention staff. |
| FIT-BT weight loss | Experimental | Behavioral: FIT-BT weight lossParticipants will be provided with intervention materials that are mailed weekly to them. Participants will be provided with the enhanced BodyMedia® FIT System that includes a wearable device with Bluetooth® technology to allow participants to receive real-time feedback on calories expended and physical activity on their smart phone. This also supports self-monitoring of dietary behaviors and body weight. Participants will attend one introductory session in which a tutorial of the components of the enhanced FIT System will be provided. Participants will also receive a one-hour lesson on basic guidelines of the weight loss intervention. Once per month participants will receive a scheduled 10 minute intervention telephone call with the intervention staff. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 21-55 years of age
- Body mass index (BMI) between 35.0-45.0 kg/m2
Key exclusion criteria (15 listed)
- Reports not having access to a computer, access to the Internet, or the availability to download software onto a computer.
- Reports not having a smart phone device that is compatible with the BodyMedia® FIT Bluetooth® System that will be examined in this study.
- Has a physical limitation that would prevent engaging in physical activity.
- Participates in structured aerobic exercise for ≥ 60 minutes per week over the prior ≥ 3 months.
- Reports being treated for a current medical condition that could affect body weight. These may include the following: cancer; diabetes mellitus; hyperthyroidism; inadequately controlled hypothyroidism; chronic renal insufficiency; chronic liver disease; gastrointestinal disorders including ulcerative colitis, Crohn's disease, or malabsorption syndromes, etc.
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 |
|---|---|---|
| In-Person weight lossParticipants will attend weekly group intervention meetings. These sessions will address barriers associated with altering physical activity participation and dietary intake. Group discussions will be facilitated by the interventionist and interactive participation will be encouraged. Participants will be provided with written materials at each meeting to supplement group discussions. Paper diaries will be provided each week to assist participants with self-monitoring of calorie and fat consumption, and physical activity minutes and intensity. Participants will return the diary to the intervention staff each week for review and constructive feedback. | Behavioural | In-Person weight loss |
| FIT weight lossIntervention materials will be provided and mailed weekly to participants. Participants will be provided with the BodyMedia® FIT System that includes a wearable device to monitor physical activity and energy expenditure, a display device to provide feedback on achievement of energy expenditure and physical activity goals, and web-based software to assist with self-monitoring of dietary intake and to provide feedback on goal achievement. Participants will attend one introductory session in which a tutorial of the components of the enhanced FIT System will be provided. Participants will receive a one-hour lesson on basic guidelines of the weight loss intervention. Once per month participants will receive a scheduled 10 minute intervention telephone call with the intervention staff. | Behavioural | FIT weight loss |
| FIT-BT weight lossParticipants will be provided with intervention materials that are mailed weekly to them. Participants will be provided with the enhanced BodyMedia® FIT System that includes a wearable device with Bluetooth® technology to allow participants to receive real-time feedback on calories expended and physical activity on their smart phone. This also supports self-monitoring of dietary behaviors and body weight. Participants will attend one introductory session in which a tutorial of the components of the enhanced FIT System will be provided. Participants will also receive a one-hour lesson on basic guidelines of the weight loss intervention. Once per month participants will receive a scheduled 10 minute intervention telephone call with the intervention staff. | Behavioural | FIT-BT weight loss |
Primary outcome
Change in body weight
Time frame: Baseline, 3 months, and 6 months
5 secondary outcomes
Change in body composition
Time frame: Baseline, 3 months, and 6 months
Change in moderate-to-vigorous intensity physical activity
Time frame: Baseline, 3 months, and 6 months
Change in dietary intake
Time frame: Baseline, 3 months, and 6 months
Completion of self-monitoring of eating behavior
Time frame: Baseline to 6 months
Frequency of self-monitoring of physical activity behavior
Time frame: Baseline to 6 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 5 Aug 2015.
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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.
John M Jakicic, PhD principal investigator
University of Pittsburgh
Renee J Rogers, MS principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-Person weight loss, FIT weight loss and FIT-BT weight loss in people with Obesity, run by University of Pittsburgh 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 15 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 5 Aug 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 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 body weight (time frame: Baseline, 3 months, and 6 months). 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 5 Aug 2015.