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N/A N=194 Randomized Double-blind Treatment

Randomized Controlled Clinical Trial of Weight Loss Programs in Obese Persons

Obesity

Enrolled (actual)
194
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Change in Weight From Baseline to 18 Months — -5.0; -3.2 kg

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
SHINE (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of California, San Francisco
Primary completion
Aug 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Weight From Baseline to 18 Months
-5.0; -3.2
SECONDARY
Fat Distribution
-4.8; -3.6
SECONDARY
Insulin Sensitivity
-.011; 0.50
SECONDARY
Change in Perceived Stress From Baseline to 18 Months
-1.03; -0.11
SECONDARY
Change in Positive Emotions Subscale of the Differential Emotions Scale
2.49; -0.21
SECONDARY
Stress Hormones
SECONDARY
Autonomic Nervous System Function
SECONDARY
Adipocyte Activity
SECONDARY
Influenza Vaccine Response

Summary

The purpose of this study is to compare two approaches to a diet and exercise-based weight loss program.

Eligibility Criteria

Inclusion Criteria

  • Age 18+ years old
  • BMI > 30-45
  • Waist circumference > 102 cm (men) or > 88 cm (women)
  • Live in San Francisco Bay Area and able to attend more than 16 classes and up to 12 assessment visits in San Francisco over an 18 month period

Exclusion Criteria

  • Inability to provide informed consent
  • Age 4mU/mL (or the upper limit of normal reference defined by the lab doing the assay)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00960414). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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