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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL136769-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Small Steps Labs, LLC | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMART 2.0 | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | Objectively measured weight in kilograms. | Baseline, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Mass Index | Weight and height will be combined to report BMI in kg/m^2. | Baseline, 24 months |
| Percent Weight Change | Percent change in weight from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Job G Godino, PhD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27426247 | Background | 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. | |
| 40948958 | Derived |
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After eligibility and consent were confirmed and baseline measurements were completed, participants were stratified by sex and university/college and then randomized within each stratum at a ratio of 1:1:1 to one of three study arms.
Young adults aged 18-35 years were recruited from 3 universities and 5 community colleges in San Diego, CA through digital advertisements, print and digital flyers, email listservs, and campus-wide events. Interested individuals were directed to secure online screening form. Eligibility criteria were confirmed through telephone screening with study staff. Eligible were invited to schedule a baseline appointment. There participants were rescreened, provided written informed consent, and enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment One | 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. |
| FG001 | Treatment Two | 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. |
| FG002 | Control | Participants assigned to the control group will receive a consumer-level wearable and scale with a corresponding app to use at their discretion. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment One | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Weight | Objectively measured weight in kilograms. | Posted | Mean | Standard Deviation | Kilograms | Baseline, 24 months |
|
The duration of the study (24 months).
Adverse event was collected at each follow-up timepoint for all participants and via participant self-report throughout the trial period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment One | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious mental health episode | Psychiatric disorders | Systematic Assessment | New diagnosis for mental health disorder after displaying life-threatening behaviors. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle or bone injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Job Godino | University of California, San Diego | 6195152344 | 2344 | jobg@fhcsd.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2019 | Mar 20, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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The study is a 24-month parallel-group randomized controlled trial.
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|
| 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. | 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. | Baseline, 24 months |
| Change in Waist Circumference | Objectively measured in centimeters. | 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. | 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). | 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). | Baseline, 24 months |
| Change in Systolic Blood Pressure | Systolic blood pressure in mmHg. | Baseline, 24 months |
| Change in Diastolic Blood Pressure | Diastolic blood pressure in mmHg. | Baseline, 24 months |
| Change in Cardiorespiratory Fitness | Three-minute step test. | Baseline, 24 months |
| Change in Flexibility | Sit and reach test. | Baseline, 24 months |
| Change in Grip Strength | Grip strength of the right and left hands in kilograms with a dynamometer. | Baseline, 24 months |
| Physical Activity | Measured using Fitbit. | Through study completion, up to 24 months |
| Physical Activity | Measured using a waist-worn tri-axial accelerometer. | 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. | Baseline, 24 months |
| Sleep | Measured using Fitbit. | 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. | Baseline, 24 months |
| Resting Heart Rate | Measured using Fitbit. | Through study completion, up to 24 months |
| Change in Resting Heart Rate | Measured by research assistant. | Baseline, 24 months |
| Sedentary Behavior | Measured using Fitbit. | Through study completion, up to 24 months |
| Sedentary Behavior | Measured using a waist-worn tri-axial accelerometer. | 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. | 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. | 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. | 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. | 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". | 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". | 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". | 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". | 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. | 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". | 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". | 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. | 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". | 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. | 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. | 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". | Baseline, 24 months |
| 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. |
| 38375882 | Derived | 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. |
| 34980208 | Derived | 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. |
| Pregnancy |
|
| Lost to Follow-up |
|
| BG001 | Treatment Two | 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. |
| BG002 | Control | Participants assigned to the control group will receive a consumer-level wearable and scale with a corresponding app to use at their discretion. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Body Mass Index | Body Mass Index (BMI) calculated as kg/m^2 | Mean | Standard Deviation | kg/m^2 |
|
| Weight | Measured in kilograms. | Mean | Standard Deviation | Kilograms |
|
| Waist circumference | Measured following standardized procedures from the approximate midpoint between the low margin of the last palpable rib and the top of the iliac crest. | Mean | Standard Deviation | Centimeters |
|
| OG001 | Treatment Two | 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. SMART 2.0: 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. |
| OG002 | Control | Participants assigned to the control group will receive a consumer-level wearable and scale with a corresponding app to use at their discretion. |
|
|
| Secondary | Change in Body Mass Index | Weight and height will be combined to report BMI in kg/m^2. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline, 24 months |
|
|
|
| Secondary | Percent Weight Change | Percent change in weight from baseline. | Posted | Mean | Standard Deviation | percent change | Baseline, 24 months |
|
|
|
| Secondary | 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. | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | 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. | Only participants with a 24 month primary outcome measure are included in this analysis. | Posted | Count of Participants | Participants | Baseline, 24 months |
|
|
|
| Secondary | Change in Waist Circumference | Objectively measured in centimeters. | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | Change in Waist-to-hip Ratio | Waist and hip circumference will be combined to report waist-to-hip ratio in cm/cm. | Only participants with a 24 month waist and hip outcome measures are included in this analysis. | Posted | Mean | Standard Deviation | Ratio | Baseline, 24 months |
|
|
|
| Secondary | 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). | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | 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). | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | Change in Systolic Blood Pressure | Systolic blood pressure in mmHg. | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | Change in Diastolic Blood Pressure | Diastolic blood pressure in mmHg. | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | Change in Cardiorespiratory Fitness | Three-minute step test. | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | Change in Flexibility | Sit and reach test. | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | Change in Grip Strength | Grip strength of the right and left hands in kilograms with a dynamometer. | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | Physical Activity | Measured using Fitbit. | Not Posted | Dec 2025 | Through study completion, up to 24 months | Participants |
| Secondary | Physical Activity | Measured using a waist-worn tri-axial accelerometer. | Not Posted | Dec 2025 | For 7 days, at 24 months | Participants |
| Secondary | 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. | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | Sleep | Measured using Fitbit. | Not Posted | Dec 2025 | Through study completion, up to 24 months | Participants |
| Secondary | 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. | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | Resting Heart Rate | Measured using Fitbit. | Not Posted | Dec 2025 | Through study completion, up to 24 months | Participants |
| Secondary | Change in Resting Heart Rate | Measured by research assistant. | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | Sedentary Behavior | Measured using Fitbit. | Not Posted | Dec 2025 | Through study completion, up to 24 months | Participants |
| Secondary | Sedentary Behavior | Measured using a waist-worn tri-axial accelerometer. | Not Posted | Dec 2025 | For 7 days, at 24 months | Participants |
| Secondary | 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. | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | 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. | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | 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. | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | 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. | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | 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". | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | 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". | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | 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". | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | 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". | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | 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. | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | 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". | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | 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". | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | 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. | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | 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". | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | 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. | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | 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. | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| Secondary | 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". | Not Posted | Dec 2025 | Baseline, 24 months | Participants |
| 0 |
| 214 |
| 2 |
| 214 |
| 73 |
| 214 |
| EG001 | Treatment Two | 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. | 0 | 212 | 4 | 212 | 53 | 212 |
| EG002 | Control | Participants assigned to the control group will receive a consumer-level wearable and scale with a corresponding app to use at their discretion. | 0 | 212 | 2 | 212 | 40 | 212 |
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| Stroke | Nervous system disorders | Systematic Assessment | Participant experience non-related stroke |
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| Muscle/bone injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Appendectomy | Surgical and medical procedures | Systematic Assessment |
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| Asthma attack | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| COVID-19 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Serious COVID-19 case |
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| Drug overdose | Injury, poisoning and procedural complications | Systematic Assessment | Overdose on fentanyl |
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| New diagnosis for mental health problem | Psychiatric disorders | Systematic Assessment |
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| Pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Fainting | Social circumstances | Systematic Assessment |
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| New diagnosis of eating disorder | Metabolism and nutrition disorders | Systematic Assessment |
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| New diagnosis for diabetes | Metabolism and nutrition disorders | Systematic Assessment |
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| COVID-19 | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Contact Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment | Due to wearing Fitbit device for intervention |
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| Migraine | General disorders | Non-systematic Assessment |
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| Weight loss treatment | Surgical and medical procedures | Systematic Assessment |
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| Asthmatic Episode | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Outpatient surgery | Surgical and medical procedures | Systematic Assessment | Not weight loss related |
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| New skin condition | Skin and subcutaneous tissue disorders | Systematic Assessment | Not related to Fitbit |
|
| New metabolic disorder | Metabolism and nutrition disorders | Systematic Assessment |
|
| Non-muscular Injury | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |