ObesitySMARTNCT01200459
SMART: A Social and Mobile Weight Control Program for Young Adults
A study testing Social/mobile weight loss promotion intervention. in people with Obesity, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Social/mobile weight loss promotion intervention.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093-0811
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Social/mobile weight loss promotion intervention.
- Keywords
- Obesity, Weight Loss, Healthy Lifestyle, Social, Mobile, Facebook, Text Messages
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social/mobile weight loss promotion intervention.Behavioural
Social/mobile intervention for weight loss promotion, compared to control group.
| Study group | Role | What they receive |
|---|---|---|
| Social/Mobile Intervention | Experimental | Theory-based intervention to promote weight loss utilizing web, mobile phone and social media. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight status
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startMay 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Patrick, MD, MS, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200459
- Sponsor's protocol ID
- 090640
- Acronym
- SMART
- Status last verified
- Dec 2014
- First submitted
- 10 Sep 2010
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27426247Kolodziejczyk 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.
PubMed 25207513Davila 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.
PubMed 24854817Kolodziejczyk 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.
PubMed 24670075Patrick 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.
PubMed 24215774
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART: A Social and Mobile Weight Control Program for Young Adults
- ClinicalTrials.gov ID
- NCT01200459
- Acronym / sponsor ID
- SMART / 090640
- Conditions
- Obesity
- Keywords
- Obesity, Weight Loss, Healthy Lifestyle, Social, Mobile, Facebook, Text Messages
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social/Mobile Intervention | Experimental | Behavioral: Social/mobile weight loss promotion intervention.Theory-based intervention to promote weight loss utilizing web, mobile phone and social media. |
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social/mobile weight loss promotion intervention.Social/mobile intervention for weight loss promotion, compared to control group. | Behavioural | Social/Mobile Intervention |
Primary outcome
Change in weight status
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
- Derived from this study: PubMed 27426247Godino 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.
- Derived from this study: PubMed 25207513Kolodziejczyk 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.
- Derived from this study: PubMed 24854817Davila 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.
- Derived from this study: PubMed 24670075Kolodziejczyk 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.
- Derived from this study: PubMed 24215774Patrick 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social/mobile weight loss promotion intervention. in people with Obesity, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight status (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01200459, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2014.