Clinical trial NCT01537796: Comparison of a Technology-based System and an In-person Behavioral Weight Loss Intervention in the Severely Obese
Official title: Comparison of a Technology-based System and an In-person Behavioral Weight Loss Intervention in the Severely Obese
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Exercise
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2012-02-23
Enrollment: 39
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 21-55 years of age
* Body mass index (BMI) between 35.0-45.0 kg/m2

Exclusion Criteria:

* 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).
* 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.

Primary outcomes:
measure: Change in body weight
timeFrame: Baseline, 3 months, and 6 months
Secondary outcomes:
measure: Change in body composition
timeFrame: Baseline, 3 months, and 6 months
measure: Change in moderate-to-vigorous intensity physical activity
timeFrame: Baseline, 3 months, and 6 months
measure: Change in dietary intake
timeFrame: Baseline, 3 months, and 6 months
measure: Completion of self-monitoring of eating behavior
timeFrame: Baseline to 6 months
measure: Frequency of self-monitoring of physical activity behavior
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: John M Jakicic, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Renee J Rogers, MS
role: PRINCIPAL_INVESTIGATOR
References: