Clinical trial NCT03907462: SMART 2.0: Social Mobile Approaches to Reducing weighT in Young Adults
Official title: SMART 2.0: Social Mobile Approaches to Reducing weighT in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: 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
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Small Steps Labs, LLC
First posted: 2019-04-09
Enrollment: 638
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a 24-month parallel-group randomized controlled trial.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Weight
timeFrame: Baseline, 24 months
Secondary outcomes:
measure: Change in Body Mass Index
timeFrame: Baseline, 24 months
measure: Percent Weight Change
timeFrame: Baseline, 24 months
measure: Percentage of Participants Who Lost at Least 3% of Their Weight From Baseline
timeFrame: Baseline, 24 months
measure: Percentage of Participants Who Lost at Least 5% of Their Weight From Baseline
timeFrame: Baseline, 24 months
measure: Change in Waist Circumference
timeFrame: Baseline, 24 months
measure: Change in Waist-to-hip Ratio
timeFrame: Baseline, 24 months
measure: Change in Body Composition
timeFrame: Baseline, 24 months
measure: Change in Bone Mineral Density
timeFrame: Baseline, 24 months
measure: Change in Systolic Blood Pressure
timeFrame: Baseline, 24 months
measure: Change in Diastolic Blood Pressure
timeFrame: Baseline, 24 months
measure: Change in Cardiorespiratory Fitness
timeFrame: Baseline, 24 months
measure: Change in Flexibility
timeFrame: Baseline, 24 months
measure: Change in Grip Strength
timeFrame: Baseline, 24 months
measure: Physical Activity
timeFrame: Through study completion, up to 24 months
measure: Physical Activity
timeFrame: For 7 days, at 24 months
measure: Change in Physical Activity
timeFrame: Baseline, 24 months
measure: Sleep
timeFrame: Through study completion, up to 24 months
measure: Change in Sleep
timeFrame: Baseline, 24 months
measure: Resting Heart Rate
timeFrame: Through study completion, up to 24 months
measure: Change in Resting Heart Rate
timeFrame: Baseline, 24 months
measure: Sedentary Behavior
timeFrame: Through study completion, up to 24 months
measure: Sedentary Behavior
timeFrame: For 7 days, at 24 months
measure: Change in Sedentary Behavior
timeFrame: Baseline, 24 months
measure: Diet History Questionnaire III
timeFrame: Baseline, 24 months
measure: Weight Management Practices
timeFrame: Baseline, 24 months
measure: Strategies for Weight Management Questionnaire
timeFrame: Baseline, 24 months
measure: Assessment of Eating Behaviors
timeFrame: Baseline, 24 months
measure: Daily Meal Patterns
timeFrame: Baseline, 24 months
measure: Healthy Eating: Change Strategies
timeFrame: Baseline, 24 months
measure: Physical Activity: Change Strategies
timeFrame: Baseline, 24 months
measure: Physical Activity Neighborhood Environment
timeFrame: Baseline, 24 months
measure: Social Support for Healthy Eating Habits
timeFrame: Baseline, 24 months
measure: Social Support for Physical Activity
timeFrame: Baseline, 24 months
measure: Depression
timeFrame: Baseline, 24 months
measure: Anxiety
timeFrame: Baseline, 24 months
measure: Self-esteem
timeFrame: Baseline, 24 months
measure: Quality of Well-being
timeFrame: Baseline, 24 months
measure: Body Image
timeFrame: Baseline, 24 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Job G Godino, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Godino JG, Merchant G, Norman GJ, Donohue MC, Marshall SJ, Fowler JH, Calfas KJ, Huang JS, Rock CL, Griswold WG, Gupta A, Raab F, Fogg BJ, Robinson TN, Patrick K. Using social and mobile tools for weight loss in overweight and obese young adults (Project SMART): a 2 year, parallel-group, randomised, controlled trial. Lancet Diabetes Endocrinol. 2016 Sep;4(9):747-755. doi: 10.1016/S2213-8587(16)30105-X. Epub 2016 Jul 14.
citation: Mansour-Assi SJ, Golaszewski NM, Costello VL, Wing D, Persinger H, Coleman A, Lytle L, Larsen BA, Jain S, Weibel N, Rock CL, Patrick K, Hekler E, Godino JG. Social Mobile Approaches to Reducing Weight (SMART) 2.0: protocol of a randomized controlled trial among young adults in university settings. Trials. 2022 Jan 3;23(1):7. doi: 10.1186/s13063-021-05938-7.