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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: SMART 2.0


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 35 years Intending to be available for a 24 month intervention Affiliated with either University of California, San Diego (UCSD), San Diego State University (SDSU), or California State University, San Marcos (CSUSM) as a student, faculty, or staff Willing and able to use social media Willing and able to use a smartphone and text messaging Willing and able to use the wearable, scale, and corresponding app Willing and able to attend measurement visits over the 2 year intervention Willing and able to engage in moderate to vigorous physical activity Overweight or obese, but not severely obese (25 >= BMI < 40 kg/m2) Exclusion Criteria: Any comorbidities of obesity that require a clinical referral including eating disorders, pseudotumor cerebri, sleep apnea or hypoventilation syndrome, orthopedic problems, and meeting American Diabetes Association criteria for diabetes Psychiatric or medical conditions that prohibit compliance with the study protocol Had a cardiovascular event (heart attack, stroke, episode of heart failure, or revascularization procedure) within the last 6 months Currently being treated for a malignancy (other than non-melanoma skin cancer) Currently being treated and/or have an eating disorder Planning to have a weight loss surgery in the next 24 months (e.g., liposuction, lap band, gastric bypass) Pregnant, gave birth within the last 6 months, currently lactating or breastfeeding within the last 3 months, or actively planning pregnancy within the next 24 months Prescribed physical activity and/or dietary changes Prescribed medications that alter weight Enrolled in or planning to enroll in a weight loss program during the study period Lost more than 15 pounds within the past 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a 24-month parallel-group randomized controlled trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment One<br>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. | Behavioral: SMART 2.0<br>* 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.<br>|
| Experimental: Treatment Two<br>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. | Behavioral: SMART 2.0<br>* 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.<br>|
| No Intervention: Control<br>Participants assigned to the control group will receive a consumer-level wearable and scale with a corresponding app to use at their discretion. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight | Objectively measured weight in kilograms. | Baseline, 24 months | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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young adult, overweight, obesity, college, university, technology, social media, text message, health coach, intervention, weight loss, wellness, physical activity, diet, sleep, resilience, wearable, mobile application, behavior mechanism, behavior