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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT03907462
Study groupRoleWhat they receive
Treatment OneExperimentalParticipants 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 TwoExperimentalParticipants 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
ControlNo interventionParticipants 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.

  1. Change in Weight

    Objectively measured weight in kilograms.

    Measured: Baseline, 24 months

Secondary outcomes (38)
  1. Change in Body Mass Index

    Weight and height will be combined to report BMI in kg/m^2.

    Measured: Baseline, 24 months

  2. Percent Weight Change

    Percent change in weight from baseline.

    Measured: Baseline, 24 months

  3. 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

  4. 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

  5. Change in Waist Circumference

    Objectively measured in centimeters.

    Measured: Baseline, 24 months

  6. 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

  7. 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

  8. 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

  9. Change in Systolic Blood Pressure

    Systolic blood pressure in mmHg.

    Measured: Baseline, 24 months

  10. Change in Diastolic Blood Pressure

    Diastolic blood pressure in mmHg.

    Measured: Baseline, 24 months

  11. Change in Cardiorespiratory Fitness

    Three-minute step test.

    Measured: Baseline, 24 months

  12. Change in Flexibility

    Sit and reach test.

    Measured: Baseline, 24 months

  13. Change in Grip Strength

    Grip strength of the right and left hands in kilograms with a dynamometer.

    Measured: Baseline, 24 months

  14. Physical Activity

    Measured using Fitbit.

    Measured: Through study completion, up to 24 months

  15. Physical Activity

    Measured using a waist-worn tri-axial accelerometer.

    Measured: For 7 days, at 24 months

  16. 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

  17. Sleep

    Measured using Fitbit.

    Measured: Through study completion, up to 24 months

  18. 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

  19. Resting Heart Rate

    Measured using Fitbit.

    Measured: Through study completion, up to 24 months

  20. Change in Resting Heart Rate

    Measured by research assistant.

    Measured: Baseline, 24 months

  21. Sedentary Behavior

    Measured using Fitbit.

    Measured: Through study completion, up to 24 months

  22. Sedentary Behavior

    Measured using a waist-worn tri-axial accelerometer.

    Measured: For 7 days, at 24 months

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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.

  1. First posted9 Apr 2019
  2. Study start1 Apr 2019
  3. Primary completion1 Feb 2024
  4. Study completion1 Feb 2024

Resources

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)
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
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 27426247
  • Baretta 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 40948958
  • Metzendorf 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 38375882
  • Mansour-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

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.

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