NCT01200459

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
404

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started May 2011

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2010

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

3.1 years

First QC Date

September 10, 2010

Last Update Submit

December 5, 2014

Conditions

Keywords

ObesityWeight LossHealthy LifestyleSocialMobileFacebookText Messages

Outcome Measures

Primary Outcomes (1)

  • Change in weight status

    24 months

Study Arms (2)

Social/Mobile Intervention

EXPERIMENTAL

Theory-based intervention to promote weight loss utilizing web, mobile phone and social media.

Behavioral: Social/mobile weight loss promotion intervention.

Control

NO INTERVENTION

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.

Interventions

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

Social/Mobile Intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093-0811, United States

Location

Related Publications (5)

  • Godino JG, Merchant G, Norman GJ, Donohue MC, Marshall SJ, Fowler JH, Calfas KJ, Huang JS, Rock CL, Griswold WG, Gupta A, Raab F, Fogg BJ, Robinson TN, Patrick K. Using social and mobile tools for weight loss in overweight and obese young adults (Project SMART): a 2 year, parallel-group, randomised, controlled trial. Lancet Diabetes Endocrinol. 2016 Sep;4(9):747-755. doi: 10.1016/S2213-8587(16)30105-X. Epub 2016 Jul 14.

  • Kolodziejczyk JK, Norman GJ, Rock CL, Arredondo EM, Madanat H, Roesch SC, Patrick K. Strategies that predict weight loss among overweight/obese young adults. Am J Health Behav. 2014 Nov;38(6):871-80. doi: 10.5993/AJHB.38.6.9.

  • Davila EP, Kolodziejczyk JK, Norman GJ, Calfas K, Huang JS, Rock CL, Griswold W, Fowler JH, Marshall SJ, Gupta A, Patrick K. Relationships between depression, gender, and unhealthy weight loss practices among overweight or obese college students. Eat Behav. 2014 Apr;15(2):271-4. doi: 10.1016/j.eatbeh.2014.03.010. Epub 2014 Mar 27.

  • Kolodziejczyk JK, Norman GJ, Roesch SC, Rock CL, Arredondo EM, Madanat H, Patrick K. Exploratory and confirmatory factor analyses and demographic correlate models of the strategies for weight management measure for overweight or obese adults. Am J Health Promot. 2015 Mar-Apr;29(4):e147-57. doi: 10.4278/ajhp.130731-QUAN-391. Epub 2014 Mar 26.

  • Patrick K, Marshall SJ, Davila EP, Kolodziejczyk JK, Fowler JH, Calfas KJ, Huang JS, Rock CL, Griswold WG, Gupta A, Merchant G, Norman GJ, Raab F, Donohue MC, Fogg BJ, Robinson TN. Design and implementation of a randomized controlled social and mobile weight loss trial for young adults (project SMART). Contemp Clin Trials. 2014 Jan;37(1):10-8. doi: 10.1016/j.cct.2013.11.001. Epub 2013 Nov 9.

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 10, 2010

First Posted

September 13, 2010

Study Start

May 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

December 8, 2014

Record last verified: 2014-12

Locations