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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

638 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2024-02-01

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.

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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.

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is a 24-month parallel-group randomized controlled trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

SMART 2.0

Intervention Type 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.

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.

Group Type EXPERIMENTAL

SMART 2.0

Intervention Type 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.

Control

Participants assigned to the control group will receive a consumer-level wearable and scale with a corresponding app to use at their discretion.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes