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

J

John M. Jakicic, PhD

Status and phase

Completed
Phase 2

Conditions

Obesity

Treatments

Behavioral: Standard weight loss intervention
Behavioral: Technology only
Behavioral: Standard weight loss intervention plus technology

Study type

Interventional

Funder types

Other

Identifiers

NCT01134874
PRO09040121

Details and patient eligibility

About

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).

Enrollment

51 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

51 participants in 3 patient groups

Standard weight loss intervention
Experimental group
Treatment:
Behavioral: Standard weight loss intervention
Standard weight loss intervention plus technology
Experimental group
Treatment:
Behavioral: Standard weight loss intervention plus technology
Technology only
Experimental group
Treatment:
Behavioral: Technology only

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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