Trial Outcomes & Findings for SMART 2.0: Social Mobile Approaches to Reducing weighT in Young Adults (NCT NCT03907462)

Results Overview

Objectively measured weight in kilograms.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

638 participants

Primary outcome timeframe

Baseline, 24 months

Results posted on

2025-04-15

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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.	Control Participants assigned to the control group will receive a consumer-level wearable and scale with a corresponding app to use at their discretion.
Overall Study STARTED	214	212	212
Overall Study COMPLETED	187	186	180
Overall Study NOT COMPLETED	27	26	32

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	Control Participants assigned to the control group will receive a consumer-level wearable and scale with a corresponding app to use at their discretion.
Overall Study Physician Decision	1	3	1
Overall Study Withdrawal by Subject	6	3	3
Overall Study Pregnancy	4	2	6
Overall Study Lost to Follow-up	16	18	22

Baseline Characteristics

SMART 2.0: Social Mobile Approaches to Reducing weighT in Young Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment One n=214 Participants 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 n=212 Participants 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 n=212 Participants Participants assigned to the control group will receive a consumer-level wearable and scale with a corresponding app to use at their discretion.	Total n=638 Participants Total of all reporting groups
Age, Continuous	23.285 Years STANDARD_DEVIATION 4.539 • n=5 Participants	22.439 Years STANDARD_DEVIATION 4.208 • n=7 Participants	23.099 Years STANDARD_DEVIATION 4.628 • n=5 Participants	22.942 Years STANDARD_DEVIATION 4.47 • n=4 Participants
Sex: Female, Male Female	126 Participants n=5 Participants	126 Participants n=7 Participants	126 Participants n=5 Participants	378 Participants n=4 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	86 Participants n=7 Participants	86 Participants n=5 Participants	260 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	86 Participants n=5 Participants	80 Participants n=7 Participants	96 Participants n=5 Participants	262 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	128 Participants n=5 Participants	132 Participants n=7 Participants	116 Participants n=5 Participants	376 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	60 Participants n=5 Participants	50 Participants n=7 Participants	53 Participants n=5 Participants	163 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	18 Participants n=4 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants	49 Participants n=7 Participants	48 Participants n=5 Participants	141 Participants n=4 Participants
Race (NIH/OMB) More than one race	101 Participants n=5 Participants	99 Participants n=7 Participants	103 Participants n=5 Participants	303 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Body Mass Index	30.329 kg/m^2 STANDARD_DEVIATION 3.71 • n=5 Participants	30.273 kg/m^2 STANDARD_DEVIATION 3.624 • n=7 Participants	30.283 kg/m^2 STANDARD_DEVIATION 3.772 • n=5 Participants	30.295 kg/m^2 STANDARD_DEVIATION 3.696 • n=4 Participants
Weight	86.393 Kilograms STANDARD_DEVIATION 13.034 • n=5 Participants	85.008 Kilograms STANDARD_DEVIATION 13.304 • n=7 Participants	84.925 Kilograms STANDARD_DEVIATION 14.135 • n=5 Participants	85.445 Kilograms STANDARD_DEVIATION 13.494 • n=4 Participants
Waist circumference	83.264 Centimeters STANDARD_DEVIATION 6.307 • n=5 Participants	83.235 Centimeters STANDARD_DEVIATION 8.257 • n=7 Participants	83.350 Centimeters STANDARD_DEVIATION 6.393 • n=5 Participants	83.283 Centimeters STANDARD_DEVIATION 7.03 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline, 24 months

Objectively measured weight in kilograms.

Outcome measures

Outcome measures
Measure	Treatment One n=187 Participants 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. 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.	Treatment Two n=186 Participants 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.	Control n=180 Participants Participants assigned to the control group will receive a consumer-level wearable and scale with a corresponding app to use at their discretion.
Change in Weight	-0.333 Kilograms Standard Deviation 6.553	0.737 Kilograms Standard Deviation 7.631	1.202 Kilograms Standard Deviation 8.045

SECONDARY outcome

Timeframe: Baseline, 24 months

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

Outcome measures

Outcome measures
Measure	Treatment One n=129 Participants 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. 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.	Treatment Two n=125 Participants 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.	Control n=125 Participants Participants assigned to the control group will receive a consumer-level wearable and scale with a corresponding app to use at their discretion.
Change in Body Mass Index	-0.213 kg/m^2 Standard Deviation 2.199	0.015 kg/m^2 Standard Deviation 2.607	0.418 kg/m^2 Standard Deviation 2.548

SECONDARY outcome

Timeframe: Baseline, 24 months

Percent change in weight from baseline.

Outcome measures

Outcome measures
Measure	Treatment One n=153 Participants 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. 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.	Treatment Two n=153 Participants 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.	Control n=144 Participants Participants assigned to the control group will receive a consumer-level wearable and scale with a corresponding app to use at their discretion.
Percent Weight Change	-0.265 percent change Standard Deviation 7.414	0.955 percent change Standard Deviation 8.674	1.437 percent change Standard Deviation 8.829

SECONDARY outcome

Timeframe: Baseline, 24 months

Percentage of participants who lost at least 3% of their weight from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

Population: Only participants with a 24 month primary outcome measure are included in this analysis.

Percentage of participants who lost at least 5% of their weight from baseline.

Outcome measures

Outcome measures
Measure	Treatment One n=153 Participants 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. 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.	Treatment Two n=153 Participants 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.	Control n=144 Participants Participants assigned to the control group will receive a consumer-level wearable and scale with a corresponding app to use at their discretion.
Percentage of Participants Who Lost at Least 5% of Their Weight From Baseline	35 Participants	28 Participants	27 Participants

SECONDARY outcome

Timeframe: Baseline, 24 months

Objectively measured in centimeters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

Population: Only participants with a 24 month waist and hip outcome measures are included in this analysis.

Waist and hip circumference will be combined to report waist-to-hip ratio in cm/cm.

Outcome measures

Outcome measures
Measure	Treatment One n=145 Participants 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. 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.	Treatment Two n=140 Participants 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.	Control n=139 Participants Participants assigned to the control group will receive a consumer-level wearable and scale with a corresponding app to use at their discretion.
Change in Waist-to-hip Ratio	-0.622 Ratio Standard Deviation 4.033	-0.064 Ratio Standard Deviation 2.789	0.141 Ratio Standard Deviation 2.643

SECONDARY outcome

Timeframe: Baseline, 24 months

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

Bone mineral density of anterior-posterior spine (L1 - L4), hip, forearm, and total body measured with Dual-energy X-ray Absorptiometry (DXA).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

Systolic blood pressure in mmHg.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

Diastolic blood pressure in mmHg.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

Three-minute step test.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

Sit and reach test.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through study completion, up to 24 months

Measured using Fitbit.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: For 7 days, at 24 months

Measured using a waist-worn tri-axial accelerometer.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through study completion, up to 24 months

Measured using Fitbit.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through study completion, up to 24 months

Measured using Fitbit.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

Measured by research assistant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through study completion, up to 24 months

Measured using Fitbit.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: For 7 days, at 24 months

Measured using a waist-worn tri-axial accelerometer.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

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".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

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".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

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".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

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".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

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".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

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".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

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".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 24 months

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".

Outcome measures

Outcome data not reported

Adverse Events

Treatment One

Serious events: 2 serious events

Other events: 73 other events

Deaths: 0 deaths

Treatment Two

Serious events: 4 serious events

Other events: 53 other events

Deaths: 0 deaths

Control

Serious events: 2 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment One n=214 participants at risk 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 n=212 participants at risk 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 n=212 participants at risk Participants assigned to the control group will receive a consumer-level wearable and scale with a corresponding app to use at their discretion.
Psychiatric disorders Serious mental health episode	0.00% 0/214 • 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.	0.47% 1/212 • Number of events 1 • 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.	0.47% 1/212 • Number of events 1 • 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.
Nervous system disorders Stroke	0.00% 0/214 • 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.	0.47% 1/212 • Number of events 1 • 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.	0.00% 0/212 • 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.
Musculoskeletal and connective tissue disorders Muscle/bone injury	0.00% 0/214 • 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.	0.00% 0/212 • 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.	0.47% 1/212 • Number of events 1 • 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.
Surgical and medical procedures Appendectomy	0.00% 0/214 • 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.	0.47% 1/212 • Number of events 1 • 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.	0.00% 0/212 • 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.
Respiratory, thoracic and mediastinal disorders Asthma attack	0.47% 1/214 • Number of events 1 • 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.	0.00% 0/212 • 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.	0.00% 0/212 • 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.
Respiratory, thoracic and mediastinal disorders COVID-19	0.00% 0/214 • 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.	0.47% 1/212 • Number of events 1 • 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.	0.00% 0/212 • 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.
Injury, poisoning and procedural complications Drug overdose	0.47% 1/214 • Number of events 1 • 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.	0.00% 0/212 • 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.	0.00% 0/212 • 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.

Other adverse events

Additional Information

Dr. Job Godino

University of California, San Diego

Phone: 6195152344

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Treatment One n=214 participants at risk 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 n=212 participants at risk 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 n=212 participants at risk Participants assigned to the control group will receive a consumer-level wearable and scale with a corresponding app to use at their discretion.
Musculoskeletal and connective tissue disorders Muscle or bone injury	16.4% 35/214 • Number of events 38 • 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.	10.8% 23/212 • Number of events 25 • 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.	3.8% 8/212 • Number of events 11 • 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.
Psychiatric disorders New diagnosis for mental health problem	3.7% 8/214 • Number of events 9 • 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.	4.7% 10/212 • Number of events 11 • 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.	3.3% 7/212 • Number of events 8 • 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.
Pregnancy, puerperium and perinatal conditions Pregnancy	1.9% 4/214 • Number of events 4 • 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.	0.94% 2/212 • Number of events 2 • 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.	2.8% 6/212 • Number of events 6 • 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.
Social circumstances Fainting	0.47% 1/214 • Number of events 1 • 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.	1.4% 3/212 • Number of events 3 • 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.	0.00% 0/212 • 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.
Metabolism and nutrition disorders New diagnosis of eating disorder	0.93% 2/214 • Number of events 2 • 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.	1.4% 3/212 • Number of events 3 • 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.	0.47% 1/212 • Number of events 1 • 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.
Metabolism and nutrition disorders New diagnosis for diabetes	0.93% 2/214 • Number of events 2 • 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.	0.47% 1/212 • Number of events 1 • 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.	0.47% 1/212 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders COVID-19	5.1% 11/214 • Number of events 12 • 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.	0.00% 0/212 • 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.	1.9% 4/212 • Number of events 4 • 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.
Skin and subcutaneous tissue disorders Contact Dermatitis	0.93% 2/214 • Number of events 2 • 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.	0.94% 2/212 • Number of events 2 • 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.	0.00% 0/212 • 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.
General disorders Migraine	0.00% 0/214 • 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.	0.94% 2/212 • Number of events 2 • 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.	0.94% 2/212 • Number of events 2 • 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.
Surgical and medical procedures Weight loss treatment	0.93% 2/214 • Number of events 2 • 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.	0.00% 0/212 • 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.	0.47% 1/212 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Asthmatic Episode	0.00% 0/214 • 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.	0.47% 1/212 • Number of events 1 • 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.	1.4% 3/212 • Number of events 3 • 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.
Surgical and medical procedures Outpatient surgery	1.4% 3/214 • Number of events 3 • 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.	1.9% 4/212 • Number of events 4 • 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.	0.47% 1/212 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders New skin condition	0.00% 0/214 • 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.	0.00% 0/212 • 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.	0.94% 2/212 • Number of events 2 • 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.
Metabolism and nutrition disorders New metabolic disorder	0.47% 1/214 • Number of events 1 • 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.	0.47% 1/212 • Number of events 1 • 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.	1.4% 3/212 • Number of events 3 • 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.
General disorders Non-muscular Injury	1.4% 3/214 • Number of events 3 • 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.	0.47% 1/212 • Number of events 1 • 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.	0.47% 1/212 • Number of events 1 • 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.