OverweightNCT02857595
Energy Balancing Modeling and Mobile Technology to Support e-Weight Loss
A study testing Online Behavioral Weight Loss program, Weight Loss Nomogram and Bite Counter in people with Overweight and Obesity, run by The Miriam Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Online Behavioral Weight Loss program, Weight Loss Nomogram and Bite Counter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) between 27 and 45 kg/m^2
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Miriam Hospital Weight Control and Diabetes Resarch Center
Providence, Rhode Island, 02903
Graham Thomas, PhD, 401-793-8154, jthomas4@lifespan.org
Graham Thomas, PhD
About this study
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).
- Conditions
- Overweight, Obesity
- Being tested
- Online Behavioral Weight Loss program, Weight Loss Nomogram, Bite Counter
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Behavioral Weight Loss programBehavioural
Weight Loss NomogramBehavioural
Bite CounterBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Online Weight Loss Program | Active comparator | Not described Receives: Behavioral: Online Behavioral Weight Loss program |
| Online Weight Loss Program + Nomogram | Experimental | Not described Receives: Behavioral: Online Behavioral Weight Loss program; Behavioral: Weight Loss Nomogram |
| Online Weight Loss Program + Nomogram + Bite Counter | Experimental | Not described Receives: Behavioral: Online Behavioral Weight Loss program; Behavioral: Weight Loss Nomogram; Behavioral: Bite Counter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Measured: 6 months after beginning treatment
Secondary outcomes (4)
Number of online weight loss lessons viewed
Measured: 6 months after beginning treatment
Number of weeks body weight, caloric intake, and physical activity reported online
Measured: 6 months after beginning treatment
Number of weekly clinic visits attended
Measured: 6 months after beginning treatment
Average number of bites of food per day
Measured: 6 months after beginning treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Graham Thomas, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857595
- Sponsor's protocol ID
- 212715 45CFR 46.110(4)(7)
- Status last verified
- Aug 2016
- First submitted
- 2 Aug 2016
- Last updated
- 5 Aug 2016
- Results posted
- No
Publications
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.
PubMed 35356149
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Balancing Modeling and Mobile Technology to Support e-Weight Loss
- ClinicalTrials.gov ID
- NCT02857595
- Acronym / sponsor ID
- 212715 45CFR 46.110(4)(7)
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (estimated)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Online Weight Loss Program | Active comparator | Behavioral: Online Behavioral Weight Loss program |
| Online Weight Loss Program + Nomogram | Experimental | Behavioral: Online Behavioral Weight Loss program, Behavioral: Weight Loss Nomogram |
| Online Weight Loss Program + Nomogram + Bite Counter | Experimental | Behavioral: Online Behavioral Weight Loss program, Behavioral: Weight Loss Nomogram, Behavioral: Bite Counter |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body mass index (BMI) between 27 and 45 kg/m^2
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Behavioral Weight Loss program | Behavioural | Online Weight Loss Program, Online Weight Loss Program + Nomogram, Online Weight Loss Program + Nomogram + Bite Counter |
| Weight Loss Nomogram | Behavioural | Online Weight Loss Program + Nomogram, Online Weight Loss Program + Nomogram + Bite Counter |
| Bite Counter | Behavioural | Online Weight Loss Program + Nomogram + Bite Counter |
Primary outcome
Weight Loss
Time frame: 6 months after beginning treatment
4 secondary outcomes
Number of online weight loss lessons viewed
Time frame: 6 months after beginning treatment
Number of weeks body weight, caloric intake, and physical activity reported online
Time frame: 6 months after beginning treatment
Number of weekly clinic visits attended
Time frame: 6 months after beginning treatment
Average number of bites of food per day
Time frame: 6 months after beginning treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
- Derived from this study: PubMed 35356149Goldstein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Behavioral Weight Loss program, Weight Loss Nomogram and Bite Counter in people with Overweight and Obesity, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Graham Thomas, PhD (4017938154, jthomas4@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Loss (time frame: 6 months after beginning treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02857595, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2016; AzTrials last refreshed its copy on 28 Oct 2026.