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Technology and Health Coaching for Weight Loss in Young Adults (SMART 2 Trial)
N/A
Waitlist Available
Led By Job G Godino, PhD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 24 months
Awards & highlights
SMART 2 Trial Summary
This trial will test if technology and health coaching can help young adults lose weight.
Who is the study for?
The SMART 2.0 trial is for overweight young adults aged 18-35 affiliated with UCSD, SDSU, or CSUSM as students, faculty, or staff. Participants must be willing to use a wearable device and app, attend visits over two years, engage in physical activity and social media. Exclusions include severe obesity (BMI of 40 or higher), recent significant weight loss, certain medical conditions including eating disorders and diabetes, pregnancy-related criteria, current treatment for cancer.Check my eligibility
What is being tested?
SMART 2.0 evaluates the effectiveness of a weight management intervention using technology alone or combined with personal health coaching versus a control group among university-affiliated young adults over two years. The study aims to see if these approaches help reduce weight more than no intervention at all.See study design
What are the potential side effects?
Since this trial involves lifestyle interventions like diet changes and increased physical activity rather than medication there are minimal side effects expected; however participants may experience typical exercise-related discomforts such as muscle soreness.
SMART 2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in weight
Secondary outcome measures
Anxiety
Assessment of Eating Behaviors
Body Image
+33 moreOther outcome measures
Alcohol Use
Smoking & Marijuana Use
SMART 2 Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Treatment TwoExperimental Treatment1 Intervention
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 II: Treatment OneExperimental Treatment1 Intervention
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 III: ControlActive Control1 Intervention
Participants assigned to the control group will receive a consumer-level wearable and scale with a corresponding app to use at their discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SMART 2.0
2019
N/A
~640
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,520,769 Total Patients Enrolled
53 Trials studying Obesity
7,482 Patients Enrolled for Obesity
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,951,941 Total Patients Enrolled
104 Trials studying Obesity
25,856 Patients Enrolled for Obesity
Small Steps Labs, LLCUNKNOWN
2 Previous Clinical Trials
466 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You will be asked to make changes to your exercise routine or diet as part of the study.You are taking medications that can change your body weight.You are able to participate in physical activity that is moderately to very strenuous.You had a heart-related problem (like a heart attack, stroke, heart failure, or heart surgery) within the past 6 months.You have an eating disorder and are currently receiving treatment.You lost more than 15 pounds in the last three months.You are willing and able to use social media platforms.You have a medical or mental health condition that could make it difficult for you to follow the study instructions.You are currently undergoing treatment for any type of cancer except non-melanoma skin cancer.You are planning to have a weight loss surgery within the next two years.You are overweight or obese, but not extremely obese. Your body mass index (BMI) is between 25 and 40 kg/m2.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Two
- Group 2: Treatment One
- Group 3: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I able to become part of this medical experiment?
"Eligible participants for this clinical trial must have obesity and lie in the age range between 18 to 35. At present, 638 individuals are being recruited."
Answered by AI
Is it permissible for individuals over 35 years of age to enroll in this medical experiment?
"According to the information provided, this clinical trial is open solely for participants aged 18-35. However, there are 54 trials that cater towards a younger population and 206 studies specifically designed for those above 65 years old."
Answered by AI
Are there any vacancies in this trial for prospective participants?
"Reportedly, this medical trial is not currently accepting patients. Initially posted on April 1st 2019 and updated as recently as November 30th 2021, it does not seem to be enlisting participants presently; however, there are 330 other trials actively recruiting individuals for their studies at the moment."
Answered by AI
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