RECRUITING

SMARTer Weight Loss Management

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The SMARTer trial will be a three-arm, randomized controlled non-inferiority trial that compares the optimized, adaptive SMARTer intervention, fixed DPP, and Self-Guided (Control). The trial will address whether a scalable, stepped-care intervention can stand up to gold-standard DPP by achieving comparable weight loss at a lower cost. Alongside evaluation of clinical non-inferiority, a comprehensive economic evaluation will inform relative affordability. Cost information is important to inform treatment policy and change standard of care, but is sorely lacking for behavioral interventions. The SMARTer intervention reduces costs by initially offering minimal intervention to all and stepping up to offer more costly treatment components only to non-responders who fail to attain the target weight loss. A rigorous economic evaluation planned and designed alongside the SMARTer trial will provide an accurate, robust head-to-head comparison of costs, cost-effectiveness, and projected lifetime health care costs between the three arms.

Official Title

SMARTer Weight Loss Management

Quick Facts

Study Start:2024-06-25
Study Completion:2028-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05861973

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Over 18 years old
  2. * BMI of ≥25, weight \<396 lbs
  3. * Must own a Smartphone, and be willing to install the SMARTer app
  4. * Participants must also plan to reside in the Chicagoland area for the duration of their participation (i.e., 12 months)
  5. * Not enrolled in a formal weight loss program
  1. * Cerebrovascular accident or myocardial infarction within six months of enrollment
  2. * Diabetes treated with insulin
  3. * Pregnancy, lactation or intended pregnancy
  4. * Active suicidal ideation
  5. * Anorexia or bulimia
  6. * Requiring an assistive device for mobility
  7. * Taking weight loss medications, such as GLP-1 agonists

Contacts and Locations

Study Contact

Laura Scanlan, MS
CONTACT
312-503-1395
laura.scanlan@northwestern.edu

Principal Investigator

Bonnie Spring, PhD
PRINCIPAL_INVESTIGATOR
Northwestern University

Study Locations (Sites)

Northwestern University
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Bonnie Spring, PhD, PRINCIPAL_INVESTIGATOR, Northwestern University

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 Registration Dates

Study Start Date2024-06-25
Study Completion Date2028-01-01

Study Record Updates

Study Start Date2024-06-25
Study Completion Date2028-01-01

Terms related to this study

Keywords Provided by Researchers

  • stepped care
  • adaptive intervention
  • non-inferiority trial
  • behavioral obesity treatment

Additional Relevant MeSH Terms

  • Obesity