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Clinical Trials/NCT01200459
NCT01200459
Completed
Not Applicable

SMART: A Social and Mobile Weight Control Program for Young Adults

University of California, San Diego1 site in 1 country404 target enrollmentMay 2011
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
University of California, San Diego
Enrollment
404
Locations
1
Primary Endpoint
Change in weight status
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The Social/Mobile Approach to Reduce Weight (SMART) study is a 24-month randomized control trial designed to evaluate the hypothesis that weight status at 24 months will be significantly better for the SMART intervention recipients than for those who receive the comparison condition.

Detailed Description

The focus of the SMART study is to develop an intervention to promote weight loss in overweight or obese young adults. The investigators will recruit college and university students to evaluate the effects of SMART on weight status and other metabolic, behavioral and psychosocial outcomes up to and including 24 months. The Primary aim of the study is to evaluate between condition differences in weight status at 24 months. Secondary aims will assess the impact of the SMART intervention on: Diet, physical activity, sedentary behaviors, quality of life and depression at 6, 12, 18 and 24 months; Anthropometric measures (BP, waist circumference) at 6, 12, 18 and 24 months; Differences in weight status at 6, 18 and 24 months; Level of satisfaction and amount of use of the intervention components. These aims will be applied to overweight/obese young adults. Among overweight/obese young adults, the investigators will determine whether SMART produces weight loss.

Registry
clinicaltrials.gov
Start Date
May 2011
End Date
June 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kevin Patrick, MD, MS

Professor

University of California, San Diego

Eligibility Criteria

Inclusion Criteria

  • Age 18 to 35 years
  • Intending to be available for a 24 month intervention
  • Full-time student enrollment at one of the designated San Diego college or university campuses: UCSD, SDSU, and CSU San Marcos
  • Facebook user or willingness to begin using Facebook
  • Owns personal computer
  • Owns mobile phone and uses text messaging
  • Willing to attend required research measurement visits in San Diego over the 2 year RCT
  • Participants must meet overweight and obesity criteria: 25 \< BMI \<35 kg/m2
  • English-speaking
  • Able to ambulate unassisted

Exclusion Criteria

  • Those unable to provide informed consent
  • Those with a BMI of \<25 kg/m2 or \>35 kg/m2
  • Those who have a household member on the study staff
  • Those with any comorbidities of obesity who require immediate sub-specialist referral including pseudo-tumor cerebri, sleep apnea/hypoventilation syndrome, orthopedic problems, and meeting American Diabetes Association criteria for diabetes
  • Cardiovascular event within the last 6 months
  • Systolic BP at screening of \>160 mmHg OR diastolic BP \> 100 mmHg
  • Current treatment for malignancy other than non-melanoma skin cancer
  • Psychiatric or medical condition that prohibit compliance with study protocol, prescribed dietary changes and/or moderate physical activity
  • Current treatment for eating disorder
  • Taking medications that alter weight

Outcomes

Primary Outcomes

Change in weight status

Time Frame: 24 months

Study Sites (1)

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