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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kevin Patrick, MD, MS, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01200459
First received: September 10, 2010
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

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 Intervention
Obesity
Behavioral: Social/mobile weight loss promotion intervention.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: SMART: A Social and Mobile Weight Control Program for Young Adults

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Change in weight status [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: May 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200459

Locations
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

No publications provided by University of California, San Diego

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kevin Patrick, MD, MS, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01200459     History of Changes
Other Study ID Numbers: 090640
Study First Received: September 10, 2010
Last Updated: October 22, 2013
Health Authority: United States: Institutional Review Board
United States: National Heart Lung and Blood Institute

Keywords provided by University of California, San Diego:
Obesity
Weight Loss
Healthy Lifestyle
Social
Mobile
Facebook
Text Messages

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014