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

NCT ID: NCT01134874

Last Updated: 2015-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard weight loss intervention

Group Type EXPERIMENTAL

Standard weight loss intervention

Intervention Type BEHAVIORAL

In-person weight loss sessions, dietary intake prescription of 1200-1500 kcal per day, exercise progressing to 300 minutes per week.

Standard weight loss intervention plus technology

Group Type EXPERIMENTAL

Standard weight loss intervention plus technology

Intervention Type BEHAVIORAL

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.

Technology only

Group Type EXPERIMENTAL

Technology only

Intervention Type BEHAVIORAL

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.

Interventions

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Standard weight loss intervention

In-person weight loss sessions, dietary intake prescription of 1200-1500 kcal per day, exercise progressing to 300 minutes per week.

Intervention Type BEHAVIORAL

Standard weight loss intervention plus technology

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

Technology only

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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John M. Jakicic, PhD

OTHER

Sponsor Role lead

Responsible Party

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John M. Jakicic, PhD

Professor and Chair

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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John M. Jakicic, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Steve Verba, MS

Role: STUDY_DIRECTOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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PRO09040121

Identifier Type: -

Identifier Source: org_study_id

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