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Using Artificial Intelligence to Optimize Delivery of Weight Loss Treatment (ReLearn)

Primary Purpose

Obesity, Weight Loss

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Behavioral Weight Loss Treatment
AI-optimized Behavioral Weight Loss Treatment
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Weight Loss, Behavioral treatment, Artificial intelligence

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Individuals must be of overweight or obese BMI (27-50 kg/m)
  • Individuals must be adults (aged 18-70)
  • Able and willing to engage in the remote program
  • Able to engage in physical activity (defined as walking two city blocks without stopping)
  • Individuals must also provide consent for the research team to contact their personal physician if necessary, to provide clearance or to consult about rapid weight loss
  • Access and willingness to use an Apple or Android smartphone
  • Satisfactory completion of all enrollment procedures

Exclusion Criteria:

  • Medical condition (e.g., cancer, type I diabetes, psychosis, full-threshold eating disorder) that may pose a risk to the participant during intervention or cause a change in weight
  • Currently pregnant, breastfeeding, or planning to become pregnant in the next 12 months
  • Recently began or changed the dosage of medication that can cause significant change in weight
  • History of bariatric surgery
  • Weight loss of > 5% in the previous 3 months

Sites / Locations

  • Drexel University Center for Weight, Eating and Lifestyle ScienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

BWL-S

BWL-AI

Arm Description

1 year of remote gold standard, small group-based behavioral weight loss treatment with an MS-level clinician.

1 year of remote weight loss treatment made up of a combination of (1) remote small group-based behavioral weight loss sessions, (2) 12-minute individual video calls, (2) automated text messages. An MS-level clinician will deliver the group treatment. Most video calls will be delivered by a paraprofessional coach, but some by an MS-level clinician. Each week the AI system will select one of the interventions for each participant based on which treatment the participant has responded to the best, within certain time constraints.

Outcomes

Primary Outcome Measures

Weight change
Weight will be measured using the Fitbit Aria Air wireless scale, which is accurate to 0.2 kg. In order to maximize accuracy, we will (1) provide instructions (e.g., place scale on flat, hard surface; weigh upon waking, without clothes, after using the bathroom), (2) require participants to confirm that they are following instructions at each assessment point, (3) use an average of 5 consecutive daily weights for each timepoint, (4) remove errant weights (e.g., >1 kg change in 1 day).
Costs
All time spent training counselors, participants and supervising counselors, will be tracked by the project coordinator, as will time counselors spend delivering individual and group treatment. The web portal will track counselor time on the portal, e.g., reviewing food records and texting. While the basic time commitments are pre-set by condition, several factors will vary including participant no-shows, participant drop-outs, and counselor adherence to time limits.

Secondary Outcome Measures

Physical Activity
Minutes of moderate to vigorous physical activity (MVPA) will be measured via Fitbit, a consumer-grade wrist-worn activity tracker which has superior compliance and close-to-equivalent accuracy as a research-grade accelerometer. Number of days meeting MVPA goal will be used by the AI system, with MVPA minutes as a secondary outcome.
Calorie intake
Seven days of calorie intake as derived from the Fitbit app's food log will be used as a secondary outcome. Participants will already be tracking their consumption using the app because data are used by both the coaches (per standard treatment) and the AI system.
Acceptability as Measured by Likert Self-report Scale
Participants will be asked to rate satisfaction with and perceived effectiveness of the program. Counselors will rate effectiveness and ease of use.

Full Information

First Posted
January 26, 2022
Last Updated
May 4, 2022
Sponsor
Drexel University
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1. Study Identification

Unique Protocol Identification Number
NCT05231824
Brief Title
Using Artificial Intelligence to Optimize Delivery of Weight Loss Treatment
Acronym
ReLearn
Official Title
Using Artificial Intelligence to Optimize Delivery of Weight Loss Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2022 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Drexel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Project ReLearn is testing the efficacy and cost-effectiveness of an Artificial Intelligence system for optimizing weight loss coaching. Participants are randomized to a 1-year weekly gold standard behavioral weight loss remote (video) group treatment or the AI-optimized treatment, which is made up of a combination of remote group treatment, short video call and automated message. In the AI-optimized condition, the system monitors outcomes (via wireless scale, mobile phone app, and wristworn tracker) and, each week, assigns each participant the treatments they have responding to the best, within certain time constraints.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss
Keywords
Obesity, Weight Loss, Behavioral treatment, Artificial intelligence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
336 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BWL-S
Arm Type
Active Comparator
Arm Description
1 year of remote gold standard, small group-based behavioral weight loss treatment with an MS-level clinician.
Arm Title
BWL-AI
Arm Type
Experimental
Arm Description
1 year of remote weight loss treatment made up of a combination of (1) remote small group-based behavioral weight loss sessions, (2) 12-minute individual video calls, (2) automated text messages. An MS-level clinician will deliver the group treatment. Most video calls will be delivered by a paraprofessional coach, but some by an MS-level clinician. Each week the AI system will select one of the interventions for each participant based on which treatment the participant has responded to the best, within certain time constraints.
Intervention Type
Behavioral
Intervention Name(s)
Standard Behavioral Weight Loss Treatment
Intervention Description
Behavioral weight loss treatment is the current gold standard treatment for obesity.
Intervention Type
Behavioral
Intervention Name(s)
AI-optimized Behavioral Weight Loss Treatment
Intervention Description
AI-optimized Behavioral Weight Loss Treatment will continuously vary intensity (automated text message, videoconference group, individual coaching call) and coach type (paraprofessional or MS-level expert) based on continuously-monitored participant digital data.
Primary Outcome Measure Information:
Title
Weight change
Description
Weight will be measured using the Fitbit Aria Air wireless scale, which is accurate to 0.2 kg. In order to maximize accuracy, we will (1) provide instructions (e.g., place scale on flat, hard surface; weigh upon waking, without clothes, after using the bathroom), (2) require participants to confirm that they are following instructions at each assessment point, (3) use an average of 5 consecutive daily weights for each timepoint, (4) remove errant weights (e.g., >1 kg change in 1 day).
Time Frame
Baseline, 1-month, 6-month, and 12-month assessment
Title
Costs
Description
All time spent training counselors, participants and supervising counselors, will be tracked by the project coordinator, as will time counselors spend delivering individual and group treatment. The web portal will track counselor time on the portal, e.g., reviewing food records and texting. While the basic time commitments are pre-set by condition, several factors will vary including participant no-shows, participant drop-outs, and counselor adherence to time limits.
Time Frame
Baseline, 1-month, 6-month, and 12-month assessment
Secondary Outcome Measure Information:
Title
Physical Activity
Description
Minutes of moderate to vigorous physical activity (MVPA) will be measured via Fitbit, a consumer-grade wrist-worn activity tracker which has superior compliance and close-to-equivalent accuracy as a research-grade accelerometer. Number of days meeting MVPA goal will be used by the AI system, with MVPA minutes as a secondary outcome.
Time Frame
Baseline, 1-month, 6-month, and 12-month assessment
Title
Calorie intake
Description
Seven days of calorie intake as derived from the Fitbit app's food log will be used as a secondary outcome. Participants will already be tracking their consumption using the app because data are used by both the coaches (per standard treatment) and the AI system.
Time Frame
Baseline, 1-month, 6-month, and 12-month assessment
Title
Acceptability as Measured by Likert Self-report Scale
Description
Participants will be asked to rate satisfaction with and perceived effectiveness of the program. Counselors will rate effectiveness and ease of use.
Time Frame
6-month and 12-month assessment
Other Pre-specified Outcome Measures:
Title
Self-regulation capacity
Description
Self-regulation capacity will be measured directly using the Brief Self-Control Scale (which has strong retest reliability and internal consistency and predicts weight loss and dietary health).
Time Frame
Baseline and 1-month assessment
Title
Autonomous motivation
Description
Autonomous motivation will be measured by the internally consistent and valid Treatment Self-Regulation Questionnaire.
Time Frame
Baseline and 1-month assessment
Title
Depressive symptoms
Description
Depressive symptoms will be measured with the 20-item Center for Epidemiologic Studies Depression Scale. This self-report scale is widely used and has proven reliable across a variety of demographic groups and in both clinical and nonclinical populations.
Time Frame
Baseline and 1-month assessment
Title
Binge eating
Description
Binge eating will be measured with the Binge Eating Module of the Eating Disorders Examination (EDE), which is a well-validated, reliable measure of eating disorder symptoms that differentiates between individuals with and without Binge Eating Disorder in
Time Frame
Baseline and 1-month assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals must be of overweight or obese BMI (27-50 kg/m) Individuals must be adults (aged 18-70) Able and willing to engage in the remote program Able to engage in physical activity (defined as walking two city blocks without stopping) Individuals must also provide consent for the research team to contact their personal physician if necessary, to provide clearance or to consult about rapid weight loss Access and willingness to use an Apple or Android smartphone Satisfactory completion of all enrollment procedures Exclusion Criteria: Medical condition (e.g., cancer, type I diabetes, psychosis, full-threshold eating disorder) that may pose a risk to the participant during intervention or cause a change in weight Currently pregnant, breastfeeding, or planning to become pregnant in the next 12 months Recently began or changed the dosage of medication that can cause significant change in weight History of bariatric surgery Weight loss of > 5% in the previous 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhuoran Huang, BA
Phone
267-603-2390
Email
zh424@drexel.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan M Forman, PhD
Organizational Affiliation
Drexel University Center for Weight, Eating and Lifestyle Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drexel University Center for Weight, Eating and Lifestyle Science
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhuoran Huang, BA
Phone
267-603-2390
Email
zh424@drexel.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Using Artificial Intelligence to Optimize Delivery of Weight Loss Treatment

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