The Comparison of a Technology-Based System and an In-Person Behavioral Weight Loss Intervention
1 other identifier
interventional
51
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 obesity
Started Aug 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 25, 2010
CompletedFirst Posted
Study publicly available on registry
June 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedAugust 5, 2015
August 1, 2015
1.1 years
May 25, 2010
August 4, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
weight
Body weight will be assessed on a digital scale to assess change in body weight over the intervention period.
change from 0 to 6 months
Secondary Outcomes (6)
cardiorespiratory fitness
0, 6, 12, months
body composition
0, 6, 12 months
physical activity
0, 6, 12 months
dietary intake
0, 6, 12 months
psychosocial and behavioral measures
0, 6, 12 months
- +1 more secondary outcomes
Study Arms (3)
Standard weight loss intervention
EXPERIMENTALStandard weight loss intervention plus technology
EXPERIMENTALTechnology only
EXPERIMENTALInterventions
In-person weight loss sessions, dietary intake prescription of 1200-1500 kcal per day, exercise progressing to 300 minutes per week.
In-person weight loss sessions, dietary intake prescription of 1200-1500 kcal per day, exercise progressing to 300 minutes per week, plus technology to provide real-time feedback on energy expenditure, plus a website to log dietary intake.
One intervention telephone call per month, dietary intake prescription of 1200-1500 kcal per day, exercise progressing to 300 minutes per week, plus technology to provide real-time feedback on energy expenditure, plus a website to log dietary intake.
Eligibility Criteria
You may qualify if:
- ages of 21-55 years
- Body mass index (BMI) between 25-39.9 kg/m2
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John M. Jakicic, PhD
University of Pittsburgh
- STUDY DIRECTOR
Steve Verba, MS
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor and Chair
Study Record Dates
First Submitted
May 25, 2010
First Posted
June 2, 2010
Study Start
August 1, 2009
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
August 5, 2015
Record last verified: 2015-08