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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01200459
Recruitment Status : Completed
First Posted : September 13, 2010
Last Update Posted : December 8, 2014
Sponsor:
Information provided by (Responsible Party):
Kevin Patrick, MD, MS, University of California, San Diego

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Social/mobile weight loss promotion intervention. Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: SMART: A Social and Mobile Weight Control Program for Young Adults
Study Start Date : May 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Social/Mobile Intervention
Theory-based intervention to promote weight loss utilizing web, mobile phone and social media.
 Behavioral: Social/mobile weight loss promotion intervention.
Social/mobile intervention for weight loss promotion, compared to control group.
No Intervention: Control
Participants randomized to this group will have access to "usual care" health information via the SMART study website. This arm will be compared to our intervention group.


Outcome Measures
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Primary Outcome Measures :
  1. Change in weight status [ Time Frame: 24 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • Regular use of systemic steroids
  • Currently pregnant, gave birth within the last 6 months, currently lactating or breastfeeding within the last 3 months or intending to get pregnant over the next two years
  • Enrolled in or planning to enroll in another weight loss program
  • Past or planned (within the next 24 months) weight loss surgery
  • Current participation in a commercial weight loss program
  • Investigator discretion
  • Non-English speaking
  • Not able to ambulate unassisted
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200459


Locations
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United States, California
University of California, San Diego
La Jolla, California, United States, 92093-0811
Sponsors and Collaborators
University of California, San Diego
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kevin Patrick, MD, MS, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01200459    
Other Study ID Numbers: 090640
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014
Keywords provided by Kevin Patrick, MD, MS, University of California, San Diego:
Obesity
Weight Loss
Healthy Lifestyle
Social
 Mobile
Facebook
Text Messages
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight