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

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).

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Standard weight loss intervention; Behavioral: Standard weight loss intervention plus technology; Behavioral: Technology only

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard weight loss intervention	Behavioral: 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.
Experimental: Standard weight loss intervention plus technology	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.
Experimental: Technology only	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0, 6, 12, months
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.	0, 6, 12 months
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.	0, 6, 12 months
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.	0, 6, 12 months
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.).	0, 6, 12 months
Weight change	Body weight measured on a digital scale	weight at 0, 6, and 12 months

Collaborators and Investigators

• Sponsor: John M. Jakicic, PhD
• Investigators: Study Director: Steve Verba, MS, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: May 25, 2010
• First Submitted That Met QC Criteria: May 28, 2010
• First Posted (Estimate): June 2, 2010

Study Record Updates

• Last Update Posted (Estimate): August 5, 2015
• Last Update Submitted That Met QC Criteria: August 4, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: PRO09040121