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Comparison of Weight Loss Programs for Individuals With Severe Obesity

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Lifespan

Status

Completed

Conditions

Weight Loss
Obesity

Treatments

Behavioral: SBT + technology system (SBT+FIT)
Behavioral: Standard behavioral treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT01330329
0209-10

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of a technology-based system (the Body Media FIT system) for enhancing weight loss in severely obese individuals (BMI: ≥ 40 kg/m2). The investigators will compare two 6-month interventions: 1) a standard behavioral weight loss program (SBT) and 2) a standard behavioral weight loss program plus the use of the Body Media FIT system (SBT+FIT). The Body Media® FIT system is a novel weight loss tool consisting of an armband that measures energy expenditure, a digital display watch that provides "real time" physical activity and energy expenditure feedback, and access to a system website which allows individuals to track their food intake and set exercise and dietary goals. We will examine differences in physical activity, weight loss, and program adherence between groups.

Enrollment

29 patients

Sex

All

Ages

21 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 21-55
  • Body mass index (BMI) ≥40kg/m2 (or no more than 440 lbs)

Exclusion criteria

  • Recent weight loss (≥ 10 pounds within the past 6 months)
  • Currently pregnant, pregnant within the last 6 months, or planning on becoming pregnant in the next 6 months.
  • Presence of any condition that would limit exercise participation (assessed by the Physical Activity Readiness Questionnaire (PAR-Q)).
  • A history of myocardial infarction or other heart-related surgeries.
  • Currently enrolled in a commercial weight loss program.
  • A recent (< 1 year) diagnosis or hospitalization for a psychological condition or history of psychosis (e.g. - Schizophrenia, Bipolar, Eating Disorder)
  • Diagnosed with cancer within the past year or currently undergoing cancer treatment.
  • Currently taking weight loss medications.
  • Currently do not have daily access to a computer or Internet.
  • Individuals with diabetes

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

29 participants in 2 patient groups

SBT + technology system (SBT+FIT)
Experimental group
Description:
Participants will receive a standard behavioral weight loss program and will also be asked to use the Body Media FIT system as part of their weight loss intervention.
Treatment:
Behavioral: SBT + technology system (SBT+FIT)
Standard behavioral treatment (SBT)
Experimental group
Description:
Participants receive a standard behavioral weight loss program similar to that used in other large trials such as Look AHEAD and the Diabetes Prevention Program.
Treatment:
Behavioral: Standard behavioral treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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