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Completed

NCT Number: NCT01200459

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

La Jolla, California, 92093-0811, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Social/mobile weight loss promotion intervention.

Behavioral

Social/mobile intervention for weight loss promotion, compared to control group.

Primary outcomes

  1. Change in weight status

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Acronym: SMART

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 13, 2010
Registry last updated
Dec 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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