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SMART Weight Loss Management (SMART)

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ClinicalTrials.gov Identifier: NCT02997943
Recruitment Status : Recruiting
First Posted : December 20, 2016
Last Update Posted : May 23, 2019
Sponsor:
Collaborators:
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Bonnie Spring, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Weight Loss Behavioral: Step 1 Treatment: APP Behavioral: Step 1 Treatment: APP + Coaching Behavioral: Step 2 Treatment Strategy: Modest Step-up Behavioral: Step 2 Treatment Strategy: Vigorous Step-up Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SMART Weight Loss Management
Actual Study Start Date : June 19, 2017
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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).




Primary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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

  2. Cost effectiveness [ Time Frame: 12 months ]
    Cost/pound lost of each study sequence embedded within the SMART design.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02997943


Contacts
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Contact: Laura Martindale, MS 312-503-1395 laura.martindale@northwestern.edu

Locations
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United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Bonnie J Spring, PhD         
Sponsors and Collaborators
Northwestern University
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Bonnie Spring, PhD Northwestern University
Principal Investigator: Inbal Nahum-Shani, PhD University of Michigan

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Responsible Party: Bonnie Spring, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT02997943     History of Changes
Other Study ID Numbers: NIH NIDDK R01DK108678
R01DK108678 ( U.S. NIH Grant/Contract )
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bonnie Spring, Northwestern University:
Obesity
Weight Loss
Diet
Physical Activity
Mobile Health
Additional relevant MeSH terms:
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Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes