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Clinical Trials/NCT01134874
NCT01134874
Completed
Phase 2

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

John M. Jakicic, PhD1 site in 1 country51 target enrollmentAugust 2009
ConditionsObesity

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Obesity
Sponsor
John M. Jakicic, PhD
Enrollment
51
Locations
1
Primary Endpoint
weight
Status
Completed
Last Updated
10 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
September 2010
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
John M. Jakicic, PhD
Responsible Party
Sponsor Investigator
Principal Investigator

John M. Jakicic, PhD

Professor and Chair

University of Pittsburgh

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.

Outcomes

Primary Outcomes

weight

Time Frame: 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 Outcomes

  • physical activity(0, 6, 12 months)
  • cardiorespiratory fitness(0, 6, 12, months)
  • body composition(0, 6, 12 months)
  • dietary intake(0, 6, 12 months)
  • psychosocial and behavioral measures(0, 6, 12 months)
  • Weight change(weight at 0, 6, and 12 months)

Study Sites (1)

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