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SMART 2.0: Social Mobile Approaches to Reducing weighT in Young Adults (SMART 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03907462
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : November 21, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Small Steps Labs, LLC
Information provided by (Responsible Party):
Job Godino, University of California, San Diego

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Behavioral: SMART 2.0 Not Applicable

Detailed Description:

Weight gain is an important issue for young adults. Throughout the transition from adolescence to early adulthood, young adults encounter multiple stressors and influences that can contribute to weight gain. In turn, weight gain leads to increased risk of cardiovascular disease, diabetes, and other health issues. Thus, there is a critical need to advance our understanding of how to develop and deploy multimodal, technology-based weight-loss interventions that have the potential for long-term effects and widespread dissemination among young adults.

The SMART 2.0 study is a 24-month (96 week) parallel-group randomized control trial designed to evaluate the impact of the interventions on objectively measured weight in kg over 24 months compared to a control group. The study will recruit 642 overweight/obese young adults aged 18-35 at universities in San Diego, CA. Participants will be randomly assigned to one of three groups for a 24-month study period. The three groups include: 1) SMART 2.0 with a consumer-level wearable and scale, text messaging, social media, and technology-based health coaching; 2) SMART 2.0 with a consumer-level wearable and scale, text messaging, and social media; and 3) a control group with a consumer-level wearable and scale alone. Theory- and evidence-based content will be framed around a minimum goal of 5-10% weight loss through increased energy expenditure, decreased energy intake, and adequate sleep. Additionally, participants will be encouraged to lose 1 to 2 pounds per week until they reach a body mass index (BMI) below 25 kg/m2. Once a participant reaches a BMI less than 25 kg/m2 the goal will be to maintain their weight loss.

SMART 2.0 uses a fully integrated system of modalities that includes: 1) a popular consumer-level wearable (e.g., Fitbit Charge 3), wireless scale (e.g., Aria Scale), and corresponding app (e.g., the Fitbit app); 2) a highly tailored and interactive text messaging system; 3) multiple social media streams (e.g., Facebook, Facebook Messenger, Instagram, and Twitter); and 4) social network mechanisms of influence. The consumer-level devices and app will be used to self-monitor behavior, and their data will be passively acquired in real-time. Algorithms will be used to automatically deliver text messages to support individually tailored goal setting, performance feedback, and goal review in a highly dynamic style that reflects participants' behavioral progress towards achieving a minimum goal of 5% weight loss. Participants will be encouraged to share their data and behavioral progress with others via social networking tools. Social network mechanisms of influence will be used both within the study-space, to elicit participant-to-participant and health coach-to-participant support, as well as outside the study-space, to invoke social support and accountability from strong ties known to be important for long-term behavior change. Additionally, one group will receive monthly technology-mediated and real-time personal health coaching that is theory- and evidence-based.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 642 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study is a 24-month parallel-group randomized controlled trial.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SMART 2.0: Social Mobile Approaches to Reducing weighT in Young Adults
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

Experimental: 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.
Behavioral: 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.

No Intervention: Control
Participants assigned to the control group will receive a consumer-level wearable and scale with a corresponding app to use at their discretion.



Primary Outcome Measures :
  1. Change in weight [ Time Frame: Baseline, 24 months ]
    Objectively measured weight in kilograms.


Secondary Outcome Measures :
  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".


Other Outcome Measures:
  1. Smoking & Marijuana Use [ Time Frame: Baseline, 24 months ]
    Assessed using modified items from the Customary Drinking and Drug Use Record. Participants will respond to 26 items related to their smoking and marijuana use over the past 6 months.

  2. Alcohol Use [ Time Frame: Baseline, 24 months ]
    Assessed using modified items from the Customary Drinking and Drug Use Record. Participants will respond to 10 items related to their alcohol use over the past 6 months.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03907462


Contacts
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Contact: Shadia J Assi, MPH 8582463302 sjassi@ucsd.edu
Contact: Victoria M Costello, MPH 8582465866 vcostello@ucsd.edu

Locations
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United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Shadia J Assi, MPH         
Principal Investigator: Job G Godino, PhD         
Sub-Investigator: Kevin Patrick, MD         
Sub-Investigator: Eric Hekler, PhD         
Sub-Investigator: Cheryl Rock, PhD         
Sub-Investigator: Nadir Weibel, PhD         
Sub-Investigator: Sonia Jain, PhD         
Sub-Investigator: Karen Calfas, PhD         
Sponsors and Collaborators
University of California, San Diego
National Institutes of Health (NIH)
Small Steps Labs, LLC
Investigators
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Principal Investigator: Job G Godino, PhD University of California, San Diego

Publications:
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Responsible Party: Job Godino, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03907462     History of Changes
Other Study ID Numbers: 181862
1R01HL136769-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Job Godino, University of California, San Diego:
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
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms