Comparison of a Technology-based System and an In-person Behavioral Weight Loss Intervention in the Severely Obese
NCT ID: NCT01537796
Last Updated: 2015-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
39 participants
INTERVENTIONAL
2012-02-29
2013-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Comparison of a Technology-Based System and an In-Person Behavioral Weight Loss Intervention
NCT01134874
The Effect of HealthWear on Short-Term Weight Loss
NCT00177593
Comparison of Weight Loss Programs for Individuals With Severe Obesity
NCT01330329
Evaluation of Alternative Exercise Treatments on Weight Loss in Overweight Women.
NCT00177632
Comparison of Supervised and Unsupervised Physical Activity Programs During a Weight Loss Intervention for Adults
NCT02693132
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
In-Person weight loss
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.
In-Person weight loss
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 loss
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 weight loss
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 loss
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.
FIT-BT weight loss
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
In-Person weight loss
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 loss
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 loss
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Body mass index (BMI) between 35.0-45.0 kg/m2
Exclusion Criteria
* 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).
* 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.
21 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Pittsburgh
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
John M. Jakicic, PhD
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John M Jakicic, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Renee J Rogers, MS
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRO11120127
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.