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

December 5, 2014 updated by: Kevin Patrick, MD, MS, University of California, San Diego
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

404

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093-0811
        • University of California, San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in weight status
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

September 10, 2010

First Submitted That Met QC Criteria

September 10, 2010

First Posted (Estimate)

September 13, 2010

Study Record Updates

Last Update Posted (Estimate)

December 8, 2014

Last Update Submitted That Met QC Criteria

December 5, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 090640

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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