Energy Balancing Modeling and Mobile Technology to Support e-Weight Loss
1 other identifier
interventional
30
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 2, 2016
CompletedFirst Posted
Study publicly available on registry
August 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedAugust 5, 2016
August 1, 2016
1 year
August 2, 2016
August 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Weight Loss
6 months after beginning treatment
Secondary Outcomes (4)
Number of online weight loss lessons viewed
6 months after beginning treatment
Number of weeks body weight, caloric intake, and physical activity reported online
6 months after beginning treatment
Number of weekly clinic visits attended
6 months after beginning treatment
Average number of bites of food per day
6 months after beginning treatment
Study Arms (3)
Online Weight Loss Program
ACTIVE COMPARATOROnline Weight Loss Program + Nomogram
EXPERIMENTALOnline Weight Loss Program + Nomogram + Bite Counter
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) between 27 and 45 kg/m\^2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Miriam Hospital Weight Control and Diabetes Resarch Center
Providence, Rhode Island, 02903, United States
Related Publications (1)
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.
PMID: 35356149DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor (Research)
Study Record Dates
First Submitted
August 2, 2016
First Posted
August 5, 2016
Study Start
July 1, 2016
Primary Completion
July 1, 2017
Last Updated
August 5, 2016
Record last verified: 2016-08