Energy Balancing Modeling and Mobile Technology to Support e-Weight Loss
Primary Purpose
Overweight, Obesity
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online Behavioral Weight Loss program
Weight Loss Nomogram
Bite Counter
Sponsored by
About this trial
This is an interventional treatment trial for Overweight
Eligibility Criteria
Inclusion Criteria:
- Body mass index (BMI) between 27 and 45 kg/m^2
Exclusion Criteria:
- Self-report of health problems that make weight loss or unsupervised exercise unsafe or unreasonable
- A heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire
- Currently pregnant or intend to become pregnant in the next 6 months
- Planning to move outside of the geographic region within the next 6 months
- Self-report any cognitive or physical limitations that preclude use of a personal computer
- Participation in a study conducted at the research center in the past 2 years
- Use of a commercial weight loss program within the last 6 months
- Self-report a history of clinically diagnosed eating disorder excluding Binge Eating Disorder
- Previous surgical procedure for weight loss
- Current use of weight loss medication
- Treatment of cancer within the last 6 months
Sites / Locations
- Miriam Hospital Weight Control and Diabetes Resarch CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Online Weight Loss Program
Online Weight Loss Program + Nomogram
Online Weight Loss Program + Nomogram + Bite Counter
Arm Description
Outcomes
Primary Outcome Measures
Weight Loss
Secondary Outcome Measures
Number of online weight loss lessons viewed
Number of weeks body weight, caloric intake, and physical activity reported online
Number of weekly clinic visits attended
Average number of bites of food per day
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02857595
Brief Title
Energy Balancing Modeling and Mobile Technology to Support e-Weight Loss
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital
4. Oversight
5. Study Description
Brief Summary
Behavioral lifestyle treatment for obesity produces clinically significant weight loss and corresponding improvements in disease risk and severity when delivered via in-person group and/or individual treatment sessions. Online versions have been developed in order to reduce costs. These programs typically include weekly weight loss lessons and tailored feedback on patients' weight loss progress. However, online programs often produce suboptimal outcomes compared to programs delivered in-person due to insufficient adherence to prescribed behavioral strategies, and a lack of objective methods for behavioral self-monitoring to support adherence. One approach to monitoring and improving adherence involves tracking patients' weight loss progress on a personalized nomogram (i.e., graph). The nomogram is based on a dynamic energy balance equation and depicts the expected weight loss over time if the participant is adherent to a prescribed goal for caloric intake and physical activity. A complementary approach to measuring and intervening on adherence involves the use of mobile technology to monitor eating behavior. The Bite Counter is a wrist-worn device similar to a wristwatch that measures the timing, frequency, rate, and duration of eating events by monitoring the "wrist roll" motion that occurs when food is brought to the mouth. By using mathematical models to "calibrate" the Bite Counter to the weight loss nomogram, it may be possible to identify the optimal number of bites that any given patient should take each day in order to facilitate weight loss. The purpose of the proposed study is to conduct a small randomized controlled trial to test the feasibility, acceptability, and preliminary efficacy of adding weight loss nomograms and the Bite Counter to an established online weight loss program. A sample of 30 participants with overweight/obesity will be randomly assigned in equal proportions to one of three 12-week weight loss programs: (a) online behavioral weight loss treatment alone (OBWL), (b) online behavioral weight loss treatment plus the provision of weight loss nomograms with weekly feedback tailored to the nomogram (OBWL+N), or (c) online behavioral weight loss treatment plus the provision of weight loss nomograms with weekly feedback tailored to the nomogram and provision of a Bite Counter that can be used to alert participants when they are approaching their maximum number of prescribed bites per day (OBWL+N&BC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Online Weight Loss Program
Arm Type
Active Comparator
Arm Title
Online Weight Loss Program + Nomogram
Arm Type
Experimental
Arm Title
Online Weight Loss Program + Nomogram + Bite Counter
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Online Behavioral Weight Loss program
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss Nomogram
Intervention Type
Behavioral
Intervention Name(s)
Bite Counter
Primary Outcome Measure Information:
Title
Weight Loss
Time Frame
6 months after beginning treatment
Secondary Outcome Measure Information:
Title
Number of online weight loss lessons viewed
Time Frame
6 months after beginning treatment
Title
Number of weeks body weight, caloric intake, and physical activity reported online
Time Frame
6 months after beginning treatment
Title
Number of weekly clinic visits attended
Time Frame
6 months after beginning treatment
Title
Average number of bites of food per day
Time Frame
6 months after beginning treatment
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:
Body mass index (BMI) between 27 and 45 kg/m^2
Exclusion Criteria:
Self-report of health problems that make weight loss or unsupervised exercise unsafe or unreasonable
A heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire
Currently pregnant or intend to become pregnant in the next 6 months
Planning to move outside of the geographic region within the next 6 months
Self-report any cognitive or physical limitations that preclude use of a personal computer
Participation in a study conducted at the research center in the past 2 years
Use of a commercial weight loss program within the last 6 months
Self-report a history of clinically diagnosed eating disorder excluding Binge Eating Disorder
Previous surgical procedure for weight loss
Current use of weight loss medication
Treatment of cancer within the last 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Graham Thomas, PhD
Phone
4017938154
Email
jthomas4@lifespan.org
Facility Information:
Facility Name
Miriam Hospital Weight Control and Diabetes Resarch Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Graham Thomas, PhD
Phone
401-793-8154
Email
jthomas4@lifespan.org
First Name & Middle Initial & Last Name & Degree
Graham Thomas, PhD
First Name & Middle Initial & Last Name & Degree
Dale Bond, PhD
First Name & Middle Initial & Last Name & Degree
Carly Goldstein, PhD
First Name & Middle Initial & Last Name & Degree
Diana Thomas, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
35356149
Citation
Goldstein CM, Goldstein SP, Thomas DM, Hoover A, Bond DS, Thomas JG. The Behavioral Intervention with Technology for E-Weight Loss Study (BITES): Incorporating Energy Balance Models and the Bite Counter into an Online Behavioral Weight Loss Program. J Technol Behav Sci. 2021 Jun;6(2):406-418. doi: 10.1007/s41347-020-00181-4. Epub 2020 Nov 27.
Results Reference
derived
Learn more about this trial
Energy Balancing Modeling and Mobile Technology to Support e-Weight Loss
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