NCT03907462

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
638

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 15, 2025

Completed
Last Updated

April 15, 2025

Status Verified

March 1, 2025

Enrollment Period

4.8 years

First QC Date

March 27, 2019

Results QC Date

January 23, 2025

Last Update Submit

March 26, 2025

Conditions

Overweight and Obesity

Keywords

young adultoverweightobesitycollegeuniversitytechnologysocial mediatext messagehealth coachinterventionweight losswellnessphysical activitydietsleepresiliencewearablemobile applicationbehavior mechanismbehavior

Outcome Measures

Primary Outcomes (1)

  • Change in Weight

    Objectively measured weight in kilograms.

    Baseline, 24 months

Secondary Outcomes (38)

  • Change in Body Mass Index

    Baseline, 24 months

  • Percent Weight Change

    Baseline, 24 months

  • Percentage of Participants Who Lost at Least 3% of Their Weight From Baseline

    Baseline, 24 months

  • Percentage of Participants Who Lost at Least 5% of Their Weight From Baseline

    Baseline, 24 months

  • Change in Waist Circumference

    Baseline, 24 months

  • +33 more secondary outcomes

Study Arms (3)

Treatment One

EXPERIMENTAL

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

Treatment Two

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

SMART 2.0BEHAVIORAL

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 OneTreatment Two

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Related Publications (4)

  • 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.

    PMID: 27426247BACKGROUND

  • Baretta D, Chevance G, Mansour-Assi SJ, Costello VL, Wing D, Hekler EB, Inauen J, Godino J, Nigg CR. Exploring boundary conditions of physical activity maintenance: A secondary analysis of time-series data from a weight-loss intervention. Health Psychol Behav Med. 2025 Sep 11;13(1):2554980. doi: 10.1080/21642850.2025.2554980. eCollection 2025.

    PMID: 40948958DERIVED

  • Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.

    PMID: 38375882DERIVED

  • 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.

    PMID: 34980208DERIVED

MeSH Terms

Conditions

OverweightObesityWeight LossMotor ActivityBehavior

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Results Point of Contact

Title
Dr. Job Godino
Organization
University of California, San Diego
jobg@fhcsd.org
6195152344

Study Officials

  • Job G Godino, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study is a 24-month parallel-group randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 27, 2019

First Posted

April 9, 2019

Study Start

April 1, 2019

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

April 15, 2025

Results First Posted

April 15, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)