N/A
Completed N=638
SMART 2.0: Social Mobile Approaches to Reducing weighT in Young Adults
Overweight and Obesity
Source: ClinicalTrials.gov NCT03907462 ↗
Enrolled (actual)
638
Serious AEs
1.3%
Results posted
Apr 2025
Primary outcomePrimary: Change in Weight — -0.333; 0.737; 1.202 Kilograms
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Weight |
-0.333; 0.737; 1.202 | — |
| SECONDARY Change in Body Mass Index |
-0.213; 0.015; 0.418 | — |
| SECONDARY Percent Weight Change |
-0.265; 0.955; 1.437 | — |
| SECONDARY Percentage of Participants Who Lost at Least 3% of Their Weight From Baseline |
— | — |
| SECONDARY Percentage of Participants Who Lost at Least 5% of Their Weight From Baseline |
35; 28; 27 | — |
| SECONDARY Change in Waist Circumference |
— | — |
| SECONDARY Change in Waist-to-hip Ratio |
-0.622; -0.064; 0.141 | — |
| SECONDARY Change in Body Composition |
— | — |
| SECONDARY Change in Bone Mineral Density |
— | — |
| SECONDARY Change in Systolic Blood Pressure |
— | — |
| SECONDARY Change in Diastolic Blood Pressure |
— | — |
| SECONDARY Change in Cardiorespiratory Fitness |
— | — |
| SECONDARY Change in Flexibility |
— | — |
| SECONDARY Change in Grip Strength |
— | — |
| SECONDARY Physical Activity |
— | — |
| SECONDARY Change in Physical Activity |
— | — |
| SECONDARY Sleep |
— | — |
| SECONDARY Change in Sleep |
— | — |
| SECONDARY Resting Heart Rate |
— | — |
| SECONDARY Change in Resting Heart Rate |
— | — |
| SECONDARY Sedentary Behavior |
— | — |
| SECONDARY Change in Sedentary Behavior |
— | — |
| SECONDARY Diet History Questionnaire III |
— | — |
| SECONDARY Weight Management Practices |
— | — |
| SECONDARY Strategies for Weight Management Questionnaire |
— | — |
| SECONDARY Assessment of Eating Behaviors |
— | — |
| SECONDARY Daily Meal Patterns |
— | — |
| SECONDARY Healthy Eating: Change Strategies |
— | — |
| SECONDARY Physical Activity: Change Strategies |
— | — |
| SECONDARY Physical Activity Neighborhood Environment |
— | — |
| SECONDARY Social Support for Healthy Eating Habits |
— | — |
| SECONDARY Social Support for Physical Activity |
— | — |
| SECONDARY Depression |
— | — |
| SECONDARY Anxiety |
— | — |
| SECONDARY Self-esteem |
— | — |
| SECONDARY Quality of Well-being |
— | — |
| SECONDARY Body Image |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT03907462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.