Overweight and ObesitySMART 2NCT03907462
SMART 2.0: Social Mobile Approaches to Reducing weighT in Young Adults
A study testing SMART 2.0 in people with Overweight and Obesity, run by University of California, San Diego at 1 site in United States.
Trial summary
The SMART 2.0 study is a 24-month trial designed to evaluate the impact of the intervention with technology and personal health coaching or with technology alone on objectively measured weight among overweight young adults in a university setting over 24 months compared to a control group. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- SMART 2.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 638 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Affiliated with either University of California, San Diego (UCSD), San Diego State University (SDSU), or California State University, San Marcos (CSUSM) as a student, faculty, or staff
- Willing and able to use social media
- Willing and able to use a smartphone and text messaging
- Willing and able to use the wearable, scale, and corresponding app
Show all 9Show fewer
- Willing and able to attend measurement visits over the 2 year intervention
- Willing and able to engage in moderate to vigorous physical activity
- Overweight or obese, but not severely obese (25 >= BMI < 40 kg/m2)
Who cannot join
- Any comorbidities of obesity that require a clinical referral including eating disorders, pseudotumor cerebri, sleep apnea or hypoventilation syndrome, orthopedic problems, and meeting American Diabetes Association criteria for diabetes
- Psychiatric or medical conditions that prohibit compliance with the study protocol
- Had a cardiovascular event (heart attack, stroke, episode of heart failure, or revascularization procedure) within the last 6 months
- Currently being treated for a malignancy (other than non-melanoma skin cancer)
- Currently being treated and/or have an eating disorder
- Planning to have a weight loss surgery in the next 24 months (e.g., liposuction, lap band, gastric bypass)
Show all 11Show fewer
- Pregnant, gave birth within the last 6 months, currently lactating or breastfeeding within the last 3 months, or actively planning pregnancy within the next 24 months
- Prescribed physical activity and/or dietary changes
- Prescribed medications that alter weight
- Enrolled in or planning to enroll in a weight loss program during the study period
- Lost more than 15 pounds within the past 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
The SMART 2.0 study is a 24-month trial designed to evaluate the impact of the intervention with technology and personal health coaching or with technology alone on objectively measured weight among overweight young adults in a university setting over 24 months compared to a control group. The investigators hypothesize that both interventions will significantly improve weight compared to the control group, and the group receiving personal health coaching will experience the greatest improvement.
Read the detailed description
Weight gain is an important issue for young adults. Throughout the transition from adolescence to early adulthood, young adults encounter multiple stressors and influences that can contribute to weight gain. In turn, weight gain leads to increased risk of cardiovascular disease, diabetes, and other health issues. Thus, there is a critical need to advance our understanding of how to develop and deploy multimodal, technology-based weight-loss interventions that have the potential for long-term effects and widespread dissemination among young adults.
The SMART 2.0 study is a 24-month (96 week) parallel-group randomized control trial designed to evaluate the impact of the interventions on objectively measured weight in kg over 24 months compared to a control group. The study will recruit 642 overweight/obese young adults aged 18-35 at universities in San Diego, CA. Participants will be randomly assigned to one of three groups for a 24-month study period. The three groups include: 1) SMART 2.0 with a consumer-level wearable and scale, text messaging, social media, and technology-based health coaching; 2) SMART 2.0 with a consumer-level wearable and scale, text messaging, and social media; and 3) a control group with a consumer-level wearable and scale alone. Theory- and evidence-based content will be framed around a minimum goal of 5-10% weight loss through increased energy expenditure, decreased energy intake, and adequate sleep. Additionally, participants will be encouraged to lose 1 to 2 pounds per week until they reach a body mass index (BMI) below 25 kg/m2. Once a participant reaches a BMI less than 25 kg/m2 the goal will be to maintain their weight loss.
SMART 2.0 uses a fully integrated system of modalities that includes: 1) a popular consumer-level wearable (e.g., Fitbit Charge 3), wireless scale (e.g., Aria Scale), and corresponding app (e.g., the Fitbit app); 2) a highly tailored and interactive text messaging system; 3) multiple social media streams (e.g., Facebook, Facebook Messenger, Instagram, and Twitter); and 4) social network mechanisms of influence. The consumer-level devices and app will be used to self-monitor behavior, and their data will be passively acquired in real-time. Algorithms will be used to automatically deliver text messages to support individually tailored goal setting, performance feedback, and goal review in a highly dynamic style that reflects participants' behavioral progress towards achieving a minimum goal of 5% weight loss. Participants will be encouraged to share their data and behavioral progress with others via social networking tools. Social network mechanisms of influence will be used both within the study-space, to elicit participant-to-participant and health coach-to-participant support, as well as outside the study-space, to invoke social support and accountability from strong ties known to be important for long-term behavior change. Additionally, one group will receive monthly technology-mediated and real-time personal health coaching that is theory- and evidence-based.
- Conditions
- Overweight and Obesity
- Being tested
- SMART 2.0
- Keywords
- young adult, overweight, obesity, college, university, technology, social media, text message, health coach, intervention, weight loss, wellness, physical activity, diet, sleep, resilience, wearable, mobile application, behavior mechanism, behavior
- Medical subject headings
- Overweight, Obesity, Weight Loss, Motor Activity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART 2.0Behavioural
SMART 2.0 uses a fully integrated system of modalities that includes: 1) a popular consumer-level wearable, wireless scale, and corresponding app; 2) a highly tailored and interactive text messaging system; 3) multiple social media streams; 4) social network mechanisms of influence; and 5) technology-mediated health coaching.
| Study group | Role | What they receive |
|---|---|---|
| Treatment One | Experimental | Participants assigned to the SMART 2.0 with technology and personal health coaching treatment group (i.e., treatment one) will receive the following: 1) consumer-level wearable and scale with a corresponding app, 2) daily text messages related to physical activity, diet, sleep and weight loss/maintenance, 3) access to SMART 2.0 social media pages and content through an online group with 6 to 12 participants total, and 4) technology-mediated, real-time individual health coaching. Participants will receive 1 to 2 text messages on a daily basis; be asked to use their wearable on a daily basis and self-weigh using the scale at least once per week; be asked to interact with their online group via social media as frequently as possible; and speak with their health coach at a predetermined session schedule. Receives: Behavioral: SMART 2.0 |
| Treatment Two | Experimental | Participants assigned to the SMART 2.0 technology alone treatment group (i.e., treatment two) will receive the following: 1) consumer-level wearable and scale with a corresponding app, 2) daily text messages related to physical activity, diet, sleep and weight loss/maintenance, and 3) access to SMART 2.0 social media pages and content through an online group with 6 to 12 participants total. Participants will receive 1 to 2 text messages on a daily basis; be asked to use their wearable on a daily basis and self-weigh using the scale at least once per week; and be asked to interact with their online group via social media as frequently as possible. Receives: Behavioral: SMART 2.0 |
| Control | No intervention | Participants assigned to the control group will receive a consumer-level wearable and scale with a corresponding app to use at their discretion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Objectively measured weight in kilograms.
Measured: Baseline, 24 months
Secondary outcomes (38)
Change in Body Mass Index
Weight and height will be combined to report BMI in kg/m^2.
Measured: Baseline, 24 months
Percent Weight Change
Percent change in weight from baseline.
Measured: Baseline, 24 months
Percentage of Participants Who Lost at Least 3% of Their Weight From Baseline
Percentage of participants who lost at least 3% of their weight from baseline.
Measured: Baseline, 24 months
Percentage of Participants Who Lost at Least 5% of Their Weight From Baseline
Percentage of participants who lost at least 5% of their weight from baseline.
Measured: Baseline, 24 months
Change in Waist Circumference
Objectively measured in centimeters.
Measured: Baseline, 24 months
Change in Waist-to-hip Ratio
Waist and hip circumference will be combined to report waist-to-hip ratio in cm/cm.
Measured: Baseline, 24 months
Change in Body Composition
Total body and regional (arms, legs, trunk, and abdomen) body composition (fat mass, including an estimate of visceral adipose tissue, and lean mass) measured with Dual-energy X-ray Absorptiometry (DXA).
Measured: Baseline, 24 months
Change in Bone Mineral Density
Bone mineral density of anterior-posterior spine (L1 - L4), hip, forearm, and total body measured with Dual-energy X-ray Absorptiometry (DXA).
Measured: Baseline, 24 months
Change in Systolic Blood Pressure
Systolic blood pressure in mmHg.
Measured: Baseline, 24 months
Change in Diastolic Blood Pressure
Diastolic blood pressure in mmHg.
Measured: Baseline, 24 months
Change in Cardiorespiratory Fitness
Three-minute step test.
Measured: Baseline, 24 months
Change in Flexibility
Sit and reach test.
Measured: Baseline, 24 months
Change in Grip Strength
Grip strength of the right and left hands in kilograms with a dynamometer.
Measured: Baseline, 24 months
Physical Activity
Measured using Fitbit.
Measured: Through study completion, up to 24 months
Physical Activity
Measured using a waist-worn tri-axial accelerometer.
Measured: For 7 days, at 24 months
Change in Physical Activity
Assessed through self-report using the Global Physical Activity Questionnaire. The questionnaire is comprised of 16 questions related to physical activity in three settings that include activity at work, travel to and from places, and recreational activities, in addition to sedentary behavior. Metabolic Equivalent (MET) values are assigned to time variables according to intensity of activity, moderate or vigorous, reported in each of the settings. MET values are then used to calculate total physical activity.
Measured: Baseline, 24 months
Sleep
Measured using Fitbit.
Measured: Through study completion, up to 24 months
Change in Sleep
Assessed through self-report using an 8 item self-report questionnaire. Participants respond to questions related to sleep duration and how often they have difficulty falling asleep and staying awake, do not get enough rest.
Measured: Baseline, 24 months
Resting Heart Rate
Measured using Fitbit.
Measured: Through study completion, up to 24 months
Change in Resting Heart Rate
Measured by research assistant.
Measured: Baseline, 24 months
Sedentary Behavior
Measured using Fitbit.
Measured: Through study completion, up to 24 months
Sedentary Behavior
Measured using a waist-worn tri-axial accelerometer.
Measured: For 7 days, at 24 months
Change in Sedentary Behavior
Assessed through self-report using 5 items from the Canadian Fitness Survey and 10 items from the Past-day Adults' Sedentary Time Questionnaire. Participants respond to items from the Canadian Fitness Survey related to how much time participants spend doing sedentary activities on a 5-point response scale ranging from "Almost all of the time" to "Almost none of the time". Participants respond to items from the Past-day Adults' Sedentary Time Questionnaire related to how much time spent sitting while doing activities including working, transportation, etc. using 2 digit entry for hours and minutes. For all items, less time reported doing sedentary activities or sitting represents less sedentary behavior.
Measured: Baseline, 24 months
Diet History Questionnaire III
The Diet History Questionnaire III contains 135 food and beverage items and 26 dietary supplement items to assess diet consumption for past month. The questionnaire includes additional embedded questions for some items to assess frequency and portion size.
Measured: Baseline, 24 months
Weight Management Practices
Assessed through self-report using a 3-item questionnaire. Participants respond to items related to which behaviors they have engaged in in the past 30 days to lose weight, how often they weigh themselves using a 6 point response scale ranging from "Never" to "More than once a day", and whether they have access to a scale at home.
Measured: Baseline, 24 months
Strategies for Weight Management Questionnaire
Strategies for Weight Management Questionnaire consists of 35 items that assess how often participants use of behavioral strategies for reducing energy intake and increasing energy expenditure on a 5-point response scale ranging from "Never or hardly ever" to "Always or almost always". Values which indicate a higher frequency of strategies, "Much of the time" and "Always or almost always", show improved weight management.
Measured: Baseline, 24 months
Assessment of Eating Behaviors
Assessment of Eating Behaviors survey consists of 8 items that assess sugar sweetened beverage consumption and frequency of eating away from home on a 9-point response scale ranging from "Never or rarely" to "3 or more times per day".
Measured: Baseline, 24 months
Daily Meal Patterns
Assessed through self-report using a 7-item questionnaire. Participants respond to items related to how often they eat meals and snacks in a typical week using a 5-point response scale ranging from "0 times" to "7 times".
Measured: Baseline, 24 months
Healthy Eating: Change Strategies
Healthy Eating: Change Strategies survey consists of 15-items that assess how often participants engage in strategies that help them change their dietary habits in the past month using a 5-point response scale ranging from "Never" to "Many times".
Measured: Baseline, 24 months
Physical Activity: Change Strategies
Physical Activity: Change Strategies survey consists of 15-items that assess how often participants engage in strategies that help them change their physical activity in the past month using a 5-point response scale ranging from "Never" to "Many times".
Measured: Baseline, 24 months
Physical Activity Neighborhood Environment
Physical Activity Neighborhood Environment survey consists of 17-items that assess the environmental factors for walking and bicycling in various neighborhoods. Higher values from the scale indicate greater environmental support for physical activity.
Measured: Baseline, 24 months
Social Support for Healthy Eating Habits
Social Support for Diet survey consists of 10-items that assess perceived social support specific to health-related eating behaviors from family and friends, respectively. Each item uses a 8-point response scale that includes "does not apply" and ranges from "none" to "very often".
Measured: Baseline, 24 months
Social Support for Physical Activity
Assessed using the Physical Activity and Social Support Scale which consists of 20-items scale based in five forms of social support - companionship, emotional, instrumental, informational, and validation for physical activity. Participants respond to items on a 7-point Likert scale ranging from "never" to "always", or "not applicable".
Measured: Baseline, 24 months
Depression
Assessed using the Center for Epidemiologic Studies depression scale which consists of 10-items. Participants respond to items related to how they feel and behave on a 5-point response scale ranging from "Rarely or none of the time" to "All of the time". A score equal to or above 10 is considered depressed.
Measured: Baseline, 24 months
Anxiety
Assessed using the short-form of the state scale of the Spielberger State Trait Anxiety Inventory which consists of 6 items. Participants respond to items related to how they feel on a 4-point response scale ranging from "Not at all" to "Very much".
Measured: Baseline, 24 months
Self-esteem
Assessed using the Rosenberg Self-esteem Scale which consists of 10-items. Participants respond to items related to items related to global self-worth on a 4-point Likert scale ranging from "strongly agree" to "strongly disagree". Higher scores indicate higher self-esteem.
Measured: Baseline, 24 months
Quality of Well-being
Assessed using the Quality of Well-being survey, self-administered version which consists of 71 items. Participants respond to items related to health status and overall well-being over the previous 3 days. Scores are translated to quality-adjusted life years.
Measured: Baseline, 24 months
Body Image
Assessed using the Eating Disorder Inventory, Body Dissatisfaction sub scale which consists of 9-items. Participants respond to items related to their body image on a 6-point response scale ranging from "Never" to "Always".
Measured: Baseline, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 Apr 2019
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a 24-month parallel-group randomized controlled trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 638 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Small Steps Labs, LLC
- Responsible party
- Principal investigator, Job Godino, University of California, San Diego
- Investigators
- Job G Godino, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907462
- Sponsor's protocol ID
- 181862
- Other IDs
- 1R01HL136769-01A1
- Acronym
- SMART 2
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2019
- Last updated
- 15 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 27426247Baretta D, Chevance G, Mansour-Assi SJ, Costello VL, Wing D, Hekler EB, Inauen J, Godino J, Nigg CR. Exploring boundary conditions of physical activity maintenance: A secondary analysis of time-series data from a weight-loss intervention. Health Psychol Behav Med. 2025 Sep 11;13(1):2554980. doi: 10.1080/21642850.2025.2554980. eCollection 2025.
PubMed 40948958Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.
PubMed 38375882Mansour-Assi SJ, Golaszewski NM, Costello VL, Wing D, Persinger H, Coleman A, Lytle L, Larsen BA, Jain S, Weibel N, Rock CL, Patrick K, Hekler E, Godino JG. Social Mobile Approaches to Reducing Weight (SMART) 2.0: protocol of a randomized controlled trial among young adults in university settings. Trials. 2022 Jan 3;23(1):7. doi: 10.1186/s13063-021-05938-7.
PubMed 34980208
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART 2.0: Social Mobile Approaches to Reducing weighT in Young Adults
- ClinicalTrials.gov ID
- NCT03907462
- Acronym / sponsor ID
- SMART 2 / 181862
- Conditions
- Overweight and Obesity
- Keywords
- young adult, overweight, obesity, college, university, technology, social media, text message
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 638 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Small Steps Labs, LLC
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Posted 15 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The SMART 2.0 study is a 24-month trial designed to evaluate the impact of the intervention with technology and personal health coaching or with technology alone on objectively measured weight among overweight young adults in a university setting over 24 months compared to a control group. The investigators hypothesize that both interventions will significantly improve weight compared to the control group, and the group receiving personal health coaching will experience the greatest improvement.
Detailed description
Weight gain is an important issue for young adults. Throughout the transition from adolescence to early adulthood, young adults encounter multiple stressors and influences that can contribute to weight gain. In turn, weight gain leads to increased risk of cardiovascular disease, diabetes, and other health issues. Thus, there is a critical need to advance our understanding of how to develop and deploy multimodal, technology-based weight-loss interventions that have the potential for long-term effects and widespread dissemination among young adults.
The SMART 2.0 study is a 24-month (96 week) parallel-group randomized control trial designed to evaluate the impact of the interventions on objectively measured weight in kg over 24 months compared to a control group. The study will recruit 642 overweight/obese young adults aged 18-35 at universities in San Diego, CA. Participants will be randomly assigned to one of three groups for a 24-month study period. The three groups include: 1) SMART 2.0 with a consumer-level wearable and scale, text messaging, social media, and technology-based health coaching; 2) SMART 2.0 with a consumer-level wearable and scale, text messaging, and social media; and 3) a control group with a consumer-level wearable and scale alone. Theory- and evidence-based content will be framed around a minimum goal of 5-10% weight loss through increased energy expenditure, decreased energy intake, and adequate sleep. Additionally, participants will be encouraged to lose 1 to 2 pounds per week until they reach a body mass index (BMI) below 25 kg/m2. Once a participant reaches a BMI less than 25 kg/m2 the goal will be to maintain their weight loss.
SMART 2.0 uses a fully integrated system of modalities that includes: 1) a popular consumer-level wearable (e.g., Fitbit Charge 3), wireless scale (e.g., Aria Scale), and corresponding app (e.g., the Fitbit app); 2) a highly tailored and interactive text messaging system; 3) multiple social media streams (e.g., Facebook, Facebook Messenger, Instagram, and Twitter); and 4) social network mechanisms of influence. The consumer-level devices and app will be used to self-monitor behavior, and their data will be passively acquired in real-time. Algorithms will be used to automatically deliver text messages to support individually tailored goal setting, performance feedback, and goal review in a highly dynamic style that reflects participants' behavioral progress towards achieving a minimum goal of 5% weight loss. Participants will be encouraged to share their data and behavioral progress with others via social networking tools. Social network mechanisms of influence will be used both within the study-space, to elicit participant-to-participant and health coach-to-participant support, as well as outside the study-space, to invoke social support and accountability from strong ties known to be important for long-term behavior change. Additionally, one group will receive monthly technology-mediated and real-time personal health coaching that is theory- and evidence-based.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study is a 24-month parallel-group randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Treatment One | Experimental | Behavioral: SMART 2.0Participants assigned to the SMART 2.0 with technology and personal health coaching treatment group (i.e., treatment one) will receive the following: 1) consumer-level wearable and scale with a corresponding app, 2) daily text messages related to physical activity, diet, sleep and weight loss/maintenance, 3) access to SMART 2.0 social media pages and content through an online group with 6 to 12 participants total, and 4) technology-mediated, real-time individual health coaching. Participants will receive 1 to 2 text messages on a daily basis; be asked to use their wearable on a daily basis and self-weigh using the scale at least once per week; be asked to interact with their online group via social media as frequently as possible; and speak with their health coach at a predetermined session schedule. |
| Treatment Two | Experimental | Behavioral: SMART 2.0Participants assigned to the SMART 2.0 technology alone treatment group (i.e., treatment two) will receive the following: 1) consumer-level wearable and scale with a corresponding app, 2) daily text messages related to physical activity, diet, sleep and weight loss/maintenance, and 3) access to SMART 2.0 social media pages and content through an online group with 6 to 12 participants total. Participants will receive 1 to 2 text messages on a daily basis; be asked to use their wearable on a daily basis and self-weigh using the scale at least once per week; and be asked to interact with their online group via social media as frequently as possible. |
| Control | No intervention | –Participants assigned to the control group will receive a consumer-level wearable and scale with a corresponding app to use at their discretion. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 18 to 35 years
- Intending to be available for a 24 month intervention
- Affiliated with either University of California, San Diego (UCSD), San Diego State University (SDSU), or California State University, San Marcos (CSUSM) as a student, faculty, or staff
- Willing and able to use social media
- Willing and able to use a smartphone and text messaging
Key exclusion criteria (11 listed)
- Any comorbidities of obesity that require a clinical referral including eating disorders, pseudotumor cerebri, sleep apnea or hypoventilation syndrome, orthopedic problems, and meeting American Diabetes Association criteria for diabetes
- Psychiatric or medical conditions that prohibit compliance with the study protocol
- Had a cardiovascular event (heart attack, stroke, episode of heart failure, or revascularization procedure) within the last 6 months
- Currently being treated for a malignancy (other than non-melanoma skin cancer)
- Currently being treated and/or have an eating disorder
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 |
|---|---|---|
| SMART 2.0SMART 2.0 uses a fully integrated system of modalities that includes: 1) a popular consumer-level wearable, wireless scale, and corresponding app; 2) a highly tailored and interactive text messaging system; 3) multiple social media streams; 4) social network mechanisms of influence; and 5) technology-mediated health coaching. | Behavioural | Treatment One, Treatment Two |
Primary outcome
Change in Weight
Time frame: Baseline, 24 months
Objectively measured weight in kilograms.
38 secondary outcomes
Change in Body Mass Index
Time frame: Baseline, 24 months
Percent Weight Change
Time frame: Baseline, 24 months
Percentage of Participants Who Lost at Least 3% of Their Weight From Baseline
Time frame: Baseline, 24 months
Percentage of Participants Who Lost at Least 5% of Their Weight From Baseline
Time frame: Baseline, 24 months
Change in Waist Circumference
Time frame: Baseline, 24 months
Change in Waist-to-hip Ratio
Time frame: Baseline, 24 months
Change in Body Composition
Time frame: Baseline, 24 months
Change in Bone Mineral Density
Time frame: Baseline, 24 months
Change in Systolic Blood Pressure
Time frame: Baseline, 24 months
Change in Diastolic Blood Pressure
Time frame: Baseline, 24 months
Change in Cardiorespiratory Fitness
Time frame: Baseline, 24 months
Change in Flexibility
Time frame: Baseline, 24 months
Change in Grip Strength
Time frame: Baseline, 24 months
Physical Activity
Time frame: Through study completion, up to 24 months
Physical Activity
Time frame: For 7 days, at 24 months
Change in Physical Activity
Time frame: Baseline, 24 months
Sleep
Time frame: Through study completion, up to 24 months
Change in Sleep
Time frame: Baseline, 24 months
Resting Heart Rate
Time frame: Through study completion, up to 24 months
Change in Resting Heart Rate
Time frame: Baseline, 24 months
Sedentary Behavior
Time frame: Through study completion, up to 24 months
Sedentary Behavior
Time frame: For 7 days, at 24 months
Change in Sedentary Behavior
Time frame: Baseline, 24 months
Diet History Questionnaire III
Time frame: Baseline, 24 months
Weight Management Practices
Time frame: Baseline, 24 months
Strategies for Weight Management Questionnaire
Time frame: Baseline, 24 months
Assessment of Eating Behaviors
Time frame: Baseline, 24 months
Daily Meal Patterns
Time frame: Baseline, 24 months
Healthy Eating: Change Strategies
Time frame: Baseline, 24 months
Physical Activity: Change Strategies
Time frame: Baseline, 24 months
Physical Activity Neighborhood Environment
Time frame: Baseline, 24 months
Social Support for Healthy Eating Habits
Time frame: Baseline, 24 months
Social Support for Physical Activity
Time frame: Baseline, 24 months
Depression
Time frame: Baseline, 24 months
Anxiety
Time frame: Baseline, 24 months
Self-esteem
Time frame: Baseline, 24 months
Quality of Well-being
Time frame: Baseline, 24 months
Body Image
Time frame: Baseline, 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: 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 40948958Baretta D, Chevance G, Mansour-Assi SJ, Costello VL, Wing D, Hekler EB, Inauen J, Godino J, Nigg CR. Exploring boundary conditions of physical activity maintenance: A secondary analysis of time-series data from a weight-loss intervention. Health Psychol Behav Med. 2025 Sep 11;13(1):2554980. doi: 10.1080/21642850.2025.2554980. eCollection 2025.
- Derived from this study: PubMed 38375882Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.
- Derived from this study: PubMed 34980208Mansour-Assi SJ, Golaszewski NM, Costello VL, Wing D, Persinger H, Coleman A, Lytle L, Larsen BA, Jain S, Weibel N, Rock CL, Patrick K, Hekler E, Godino JG. Social Mobile Approaches to Reducing Weight (SMART) 2.0: protocol of a randomized controlled trial among young adults in university settings. Trials. 2022 Jan 3;23(1):7. doi: 10.1186/s13063-021-05938-7.
- Individual participant dataSharing planned: No
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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.
Job G Godino, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART 2.0 in people with Overweight and 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 9 inclusion and 11 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 15 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 15 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: Baseline, 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 NCT03907462, which also lists 4 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 15 Apr 2025.