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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
638
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.
University of California, San Diego
La Jolla, California, United States
Change in Weight
Objectively measured weight in kilograms.
Time frame: Baseline, 24 months
Change in Body Mass Index
Weight and height will be combined to report BMI in kg/m\^2.
Time frame: Baseline, 24 months
Percent Weight Change
Percent change in weight from baseline.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 24 months
Change in Waist Circumference
Objectively measured in centimeters.
Time frame: 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.
Time frame: 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).
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Time frame: 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).
Time frame: Baseline, 24 months
Change in Systolic Blood Pressure
Systolic blood pressure in mmHg.
Time frame: Baseline, 24 months
Change in Diastolic Blood Pressure
Diastolic blood pressure in mmHg.
Time frame: Baseline, 24 months
Change in Cardiorespiratory Fitness
Three-minute step test.
Time frame: Baseline, 24 months
Change in Flexibility
Sit and reach test.
Time frame: Baseline, 24 months
Change in Grip Strength
Grip strength of the right and left hands in kilograms with a dynamometer.
Time frame: Baseline, 24 months
Physical Activity
Measured using Fitbit.
Time frame: Through study completion, up to 24 months
Physical Activity
Measured using a waist-worn tri-axial accelerometer.
Time frame: 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.
Time frame: Baseline, 24 months
Sleep
Measured using Fitbit.
Time frame: 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.
Time frame: Baseline, 24 months
Resting Heart Rate
Measured using Fitbit.
Time frame: Through study completion, up to 24 months
Change in Resting Heart Rate
Measured by research assistant.
Time frame: Baseline, 24 months
Sedentary Behavior
Measured using Fitbit.
Time frame: Through study completion, up to 24 months
Sedentary Behavior
Measured using a waist-worn tri-axial accelerometer.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: 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.
Time frame: 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".
Time frame: 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".
Time frame: 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.
Time frame: 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".
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: Baseline, 24 months