Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

SMART Weight Loss Management (SMART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02997943
Recruitment Status : Active, not recruiting
First Posted : December 20, 2016
Last Update Posted : March 18, 2020
Sponsor:
Collaborators:
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Bonnie Spring, Northwestern University

Tracking Information
First Submitted Date  ICMJE December 5, 2016
First Posted Date  ICMJE December 20, 2016
Last Update Posted Date March 18, 2020
Actual Study Start Date  ICMJE June 19, 2017
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2016)
Change in weight at 6 months [ Time Frame: baseline, 6 months ]
Weight measured in the lab, taken without shoes, wearing light clothing on a calibrated beam balance scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: December 16, 2016)
  • Change in weight at 12 months [ Time Frame: baseline, 12 months ]
    Weight measured in the lab, taken without shoes, wearing light clothing on a calibrated beam balance scale
  • Cost effectiveness [ Time Frame: 12 months ]
    Cost/pound lost of each study sequence embedded within the SMART design.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE SMART Weight Loss Management
Official Title  ICMJE SMART Weight Loss Management
Brief Summary The overall objective of this study is to use an innovative experimental approach, the SMART (Sequential Multiple Assignment Randomized Trial), to determine the best way to sequence the delivery of mHealth tools and traditional treatment components in a stepped program of obesity treatments. The SMART approach is a highly efficient strategy for identifying and constructing efficacious adaptive interventions: it accommodates sequential decision-making based on the participant's response to early weight loss treatment components. The proposed treatment package begins with the least expensive components, and for participants identified as treatment non-responders, provides sequential step-up of additional treatment components. By sequentially delivering treatment components based on participant response, SMART permits achievement of the target outcome, weight loss, with least resource consumption and participant burden.
Detailed Description The proposed study seeks to develop an effective, resource-sensitive strategy to manage weight loss treatment for obesity. During the 12-week active intervention phase, participants will be randomized to one of two first-line treatments: 1) mobile app alone (APP) or 2) app plus weekly telephone coaching sessions (APP+C). Beginning at week 2, those who are identified as treatment non-responders (did not lose an average of 0.5 lbs/week) will be re-randomized to one of two augmentation tactics: 1) Modest Step-up, operationalized as the addition of an additional mHealth component, or 2) Vigorous Step-up, operationalized as the addition of an additional mHealth component plus a traditional weight loss intervention component. Treatment responders will continue with the same first-line treatment. Treatment response be re-assessed at weeks 4 and 8. Those identified as treatment non-responders will be re-randomized at that time.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Weight Loss
Intervention  ICMJE
  • Behavioral: Step 1 Treatment: APP
    Participants will receive a smartphone app to track weight, dietary intake and physical activity, and a technology core consisting of web-based weekly lessons, wireless scale, and activity tracker. Participants will use their own smartphone to receive the study smartphone application.
  • Behavioral: Step 1 Treatment: APP + Coaching
    Participants will receive a smartphone app to track weight, dietary intake and physical activity; a technology core consisting of web-based weekly lessons, wireless scale, and activity tracker; 12 weekly telephone coaching sessions. Participants will use their own smartphone to receive the study smartphone application.
  • Behavioral: Step 2 Treatment Strategy: Modest Step-up
    In addition to first line treatment, participants identified as non-responders will be provided an additional mHealth intervention component (push notifications) for the remaining 12 weeks.
  • Behavioral: Step 2 Treatment Strategy: Vigorous Step-up
    In addition to the first line treatment, participants identified as non-responders will be provided an additional mHealth intervention component (push notifications) plus a traditional weight loss intervention component (coaching, meal replacements).
Study Arms  ICMJE
  • Experimental: Step 1: Optimal First Line Treatment
    Participants will first be randomized to an optimal first line treatment in order to compare APP vs. APP + coaching. Participants assigned to Step 1 treatment "APP" will receive a study-specific smartphone application. Participants assigned to Step 1 treatment "APP + coaching" will receive a study-specific smartphone application plus 12 weekly telephone coaching sessions.
    Interventions:
    • Behavioral: Step 1 Treatment: APP
    • Behavioral: Step 1 Treatment: APP + Coaching
  • Experimental: Step 2: Optimal Strategy to Address Nonresponse
    Beginning at week 2, participants who are identified as treatment non-responders will be re-randomized in order to compare two strategies to address non-response: a modest step-up or vigorous step-up treatment augmentation tactic. Step 2 treatment strategy: modest step-up will include provision of an additional mHealth intervention component (push notifications). Step 2 treatment strategy vigorous step-up will include provision of an additional mHealth intervention component (push notifications), plus a traditional weight loss intervention component (coaching, meal replacements). Participants will continue to receive their first line treatment.
    Interventions:
    • Behavioral: Step 2 Treatment Strategy: Modest Step-up
    • Behavioral: Step 2 Treatment Strategy: Vigorous Step-up
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 16, 2016)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 through 60 years old
  • BMI between 27 - 45 kg/m2
  • < 350 lbs
  • Weight stable (no loss or gain >25 lbs. for the past 6 months)
  • Interested in losing weight and not enrolled in a formal weight loss program or taking medications or supplements that may cause weight change
  • Own a Smartphone and be willing to install the SMART App
  • Reside in the Chicago area for the duration of their participation (12 months)

Exclusion Criteria:

  • Unstable medical conditions (uncontrolled hypertension, diabetes - uncontrolled or treated with insulin, uncontrolled hypothyroidism, unstable angina pectoris, transient ischemic attack, cancer undergoing active treatment, cerebrovascular accident or myocardial infarction within the past six months, or Crohn's disease)
  • Pregnancy, lactation, or intended pregnancy
  • Active suicidal ideation, anorexia, bulimia, binge eating disorder, current substance abuse or dependence (besides nicotine dependence)
  • Require assistive device for mobility or current condition that may limit or prevent participation in moderate activity
  • Use of pacemaker or other electrical implanted device
  • History of bariatric (or LapBand) surgery, or considering or currently on a wait-list for bariatric or LapBand surgery
  • May not live with a current or past SMART study participant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02997943
Other Study ID Numbers  ICMJE NIH NIDDK R01DK108678
R01DK108678 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bonnie Spring, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE
  • University of Michigan
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Bonnie Spring, PhD Northwestern University
Principal Investigator: Inbal Nahum-Shani, PhD University of Michigan
PRS Account Northwestern University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP