SMART Weight Loss Management (SMART)

May 17, 2021 updated by: Bonnie Spring, Northwestern University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 12 months
Cost effectiveness
Time Frame: 12 months
Cost/pound lost of each study sequence embedded within the SMART design.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 19, 2017

Primary Completion (ACTUAL)

September 17, 2020

Study Completion (ACTUAL)

March 18, 2021

Study Registration Dates

First Submitted

December 5, 2016

First Submitted That Met QC Criteria

December 16, 2016

First Posted (ESTIMATE)

December 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 18, 2021

Last Update Submitted That Met QC Criteria

May 17, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIH NIDDK R01DK108678
  • R01DK108678 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Weight Loss

Clinical Trials on Step 1 Treatment: APP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe