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

Phase 2

Completed

• Conditions: Obesity
• Interventions: Behavioral: Standard weight loss intervention plus technology; Behavioral: Technology only; Behavioral: Standard weight loss intervention

• Registration Number: NCT01134874
• Lead Sponsor: John M. Jakicic, PhD

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-05-25
• Study First Submitted QC: 2010-05-28
• Study First Posted: 2010-06-02
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-04
• Last Update Posted: 2015-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard weight loss intervention plus technology	Standard weight loss intervention plus technology	-
Technology only	Technology only	-
Standard weight loss intervention	Standard weight loss intervention	-

Primary Outcome Measures

Name	Time	Method
weight	change from 0 to 6 months	Body weight will be assessed on a digital scale to assess change in body weight over the intervention period.

Secondary Outcome Measures

Name	Time	Method
physical activity	0, 6, 12 months	A questionnaire and a portable device worn on the upper arm will be used to measure and quantify energy expenditure from physical activity.
cardiorespiratory fitness	0, 6, 12, months	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	0, 6, 12 months	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.
dietary intake	0, 6, 12 months	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	0, 6, 12 months	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	weight at 0, 6, and 12 months	Body weight measured on a digital scale

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States