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The Comparison of a Technology-Based System and an In-Person Behavioral Weight Loss Intervention

Primary Purpose

Obesity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Standard weight loss intervention
Standard weight loss intervention plus technology
Technology only
Sponsored by
John M. Jakicic, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Standard weight loss intervention

Standard weight loss intervention plus technology

Technology only

Arm Description

Outcomes

Primary Outcome Measures

weight
Body weight will be assessed on a digital scale to assess change in body weight over the intervention period.

Secondary Outcome Measures

cardiorespiratory fitness
A graded exercise test on a treadmill along with indirect calorimetry will be used to measure cardiorespiratory fitness. This will provide a measure of oxygen consumption and metabolic equivalents of work at the time of test termination.
body composition
Body composition will be assessed using dual energy X-ray absorptiometry (DXA). This will provide a measure of lean body mass, fat mass, bone mineral content, and percent body fat.
physical activity
A questionnaire and a portable device worn on the upper arm will be used to measure and quantify energy expenditure from physical activity.
dietary intake
A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.
psychosocial and behavioral measures
Questionnaires will be used to assess self-efficacy for weight loss and physical activity, barriers to physical activity and weight loss, expected outcomes resulting from physical activity and weight loss, perceived body image, depressive symptomotology, weight history, dietary disinhibition and restraint, and behaviors typically related to weight loss (e.g., self-weighing, meal planning, etc.).
Weight change
Body weight measured on a digital scale

Full Information

First Posted
May 25, 2010
Last Updated
August 4, 2015
Sponsor
John M. Jakicic, PhD
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1. Study Identification

Unique Protocol Identification Number
NCT01134874
Brief Title
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

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
John M. Jakicic, PhD

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard weight loss intervention
Arm Type
Experimental
Arm Title
Standard weight loss intervention plus technology
Arm Type
Experimental
Arm Title
Technology only
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Standard weight loss intervention
Intervention Description
In-person weight loss sessions, dietary intake prescription of 1200-1500 kcal per day, exercise progressing to 300 minutes per week.
Intervention Type
Behavioral
Intervention Name(s)
Standard weight loss intervention plus technology
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Technology only
Intervention Description
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.
Primary Outcome Measure Information:
Title
weight
Description
Body weight will be assessed on a digital scale to assess change in body weight over the intervention period.
Time Frame
change from 0 to 6 months
Secondary Outcome Measure Information:
Title
cardiorespiratory fitness
Description
A graded exercise test on a treadmill along with indirect calorimetry will be used to measure cardiorespiratory fitness. This will provide a measure of oxygen consumption and metabolic equivalents of work at the time of test termination.
Time Frame
0, 6, 12, months
Title
body composition
Description
Body composition will be assessed using dual energy X-ray absorptiometry (DXA). This will provide a measure of lean body mass, fat mass, bone mineral content, and percent body fat.
Time Frame
0, 6, 12 months
Title
physical activity
Description
A questionnaire and a portable device worn on the upper arm will be used to measure and quantify energy expenditure from physical activity.
Time Frame
0, 6, 12 months
Title
dietary intake
Description
A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.
Time Frame
0, 6, 12 months
Title
psychosocial and behavioral measures
Description
Questionnaires will be used to assess self-efficacy for weight loss and physical activity, barriers to physical activity and weight loss, expected outcomes resulting from physical activity and weight loss, perceived body image, depressive symptomotology, weight history, dietary disinhibition and restraint, and behaviors typically related to weight loss (e.g., self-weighing, meal planning, etc.).
Time Frame
0, 6, 12 months
Title
Weight change
Description
Body weight measured on a digital scale
Time Frame
weight at 0, 6, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John M. Jakicic, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steve Verba, MS
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Director
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States

12. IPD Sharing Statement

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The Comparison of a Technology-Based System and an In-Person Behavioral Weight Loss Intervention

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