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Completed

NCT Number: NCT03907462

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

La Jolla, California, 92093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Weight

    Time frame: Baseline, 24 months

    Objectively measured weight in kilograms.

Secondary outcomes

  1. Change in Body Mass Index

    Time frame: Baseline, 24 months

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

  2. Percent Weight Change

    Time frame: Baseline, 24 months

    Percent change in weight from baseline.

  3. 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 3% of their weight from baseline.

  4. Percentage of Participants Who Lost at Least 5% of Their Weight From Baseline

    Time frame: Baseline, 24 months

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

  5. Change in Waist Circumference

    Time frame: Baseline, 24 months

    Objectively measured in centimeters.

  6. Change in Waist-to-hip Ratio

    Time frame: Baseline, 24 months

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

  7. Change in Body Composition

    Time frame: 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).

  8. Change in Bone Mineral Density

    Time frame: 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).

  9. Change in Systolic Blood Pressure

    Time frame: Baseline, 24 months

    Systolic blood pressure in mmHg.

  10. Change in Diastolic Blood Pressure

    Time frame: Baseline, 24 months

    Diastolic blood pressure in mmHg.

  11. Change in Cardiorespiratory Fitness

    Time frame: Baseline, 24 months

    Three-minute step test.

  12. Change in Flexibility

    Time frame: Baseline, 24 months

    Sit and reach test.

  13. Change in Grip Strength

    Time frame: Baseline, 24 months

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

  14. Physical Activity

    Time frame: Through study completion, up to 24 months

    Measured using Fitbit.

  15. Physical Activity

    Time frame: For 7 days, at 24 months

    Measured using a waist-worn tri-axial accelerometer.

  16. Change in Physical Activity

    Time frame: 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.

  17. Sleep

    Time frame: Through study completion, up to 24 months

    Measured using Fitbit.

  18. Change in Sleep

    Time frame: 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.

  19. Resting Heart Rate

    Time frame: Through study completion, up to 24 months

    Measured using Fitbit.

  20. Change in Resting Heart Rate

    Time frame: Baseline, 24 months

    Measured by research assistant.

  21. Sedentary Behavior

    Time frame: Through study completion, up to 24 months

    Measured using Fitbit.

  22. Sedentary Behavior

    Time frame: For 7 days, at 24 months

    Measured using a waist-worn tri-axial accelerometer.

  23. Change in Sedentary Behavior

    Time frame: 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.

  24. Diet History Questionnaire III

    Time frame: 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.

  25. Weight Management Practices

    Time frame: 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.

  26. Strategies for Weight Management Questionnaire

    Time frame: 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.

  27. Assessment of Eating Behaviors

    Time frame: 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".

  28. Daily Meal Patterns

    Time frame: 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".

  29. Healthy Eating: Change Strategies

    Time frame: 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".

  30. Physical Activity: Change Strategies

    Time frame: 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".

  31. Physical Activity Neighborhood Environment

    Time frame: 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.

  32. Social Support for Healthy Eating Habits

    Time frame: 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".

  33. Social Support for Physical Activity

    Time frame: 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".

  34. Depression

    Time frame: 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.

  35. Anxiety

    Time frame: 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".

  36. Self-esteem

    Time frame: 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.

  37. Quality of Well-being

    Time frame: 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.

  38. Body Image

    Time frame: 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".

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institutes of Health (NIH)
  • Small Steps Labs, LLC

Registry information

Acronym: SMART 2

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Apr 9, 2019
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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