Clinical trial NCT01134874: The Comparison of a Technology-Based System and an In-Person Behavioral Weight Loss Intervention
Official title: The Comparison of a Technology-Based System and an In-Person Behavioral Weight Loss Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2010-06-02
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to compare the changes in body weight between a technology-based system, an in-person behavioral weight loss intervention, and a combination of both during a 12 month behavioral weight loss intervention in adults. Sedentary, healthy overweight and obese adults will be recruited to participate. Assessments will be conducted at 0, 6, and 12 months. This is a randomized trial in which participants will be randomized to one of three groups: standard behavioral weight loss (SBWL), standard behavioral weight loss plus technology (SBWL+TECH), and technology alone alone (TECH).


Eligibility criteria: Inclusion Criteria:

* ages of 21-55 years
* Body mass index (BMI) between 25-39.9 kg/m2

Exclusion Criteria:

* Currently pregnant, pregnant in the last 6 months, or plan on becoming pregnant in the next 6 months.
* Currently participating in regular exercise for over 60 minutes/week.
* Taking any medications that affect body weight or metabolism (e.g. synthroid).
* Have any physical limitations that would prevent exercise.
* Currently being treated for coronary heart disease, diabetes mellitus, hypertension, or cancer.
* Have a history of myocardial infarction or other heart-related surgeries.
* Have a resting systolic blood pressure \> 150 mmHg or diastolic blood pressure of \> 100 mmHg or currently taking any medications that affect blood pressure or heart rate (e.g. beta blockers).
* Currently enrolled in a commercial weight loss program, participating in another weight loss study, or in a weight loss study in the last 12 months.
* Have lost \> 5% of current body weight in the past 6 months.
* Currently being treated for any psychological problems or taking any psychotropic medication.
* Currently do not have access to a computer and the Internet that can be used for this study. This requires a PC computer, the ability to load software for the technology system, an existing internet connection provided by the participant, and a dedicated USB port to allow the armband from the technology system to be connected to the computer for the download of information.

Primary outcomes:
measure: weight
timeFrame: change from 0 to 6 months
Secondary outcomes:
measure: cardiorespiratory fitness
timeFrame: 0, 6, 12, months
measure: body composition
timeFrame: 0, 6, 12 months
measure: physical activity
timeFrame: 0, 6, 12 months
measure: dietary intake
timeFrame: 0, 6, 12 months
measure: psychosocial and behavioral measures
timeFrame: 0, 6, 12 months
measure: Weight change
timeFrame: weight at 0, 6, and 12 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: Steve Verba, MS
role: STUDY_DIRECTOR
References: