CClinicalTrials.gg
Status unknownNCT02857595Updated Aug 5, 2016

Energy Balancing Modeling and Mobile Technology to Support e-Weight Loss

An interventional study of Online Behavioral Weight Loss program and Weight Loss Nomogram in Overweight and Obesity, sponsored by The Miriam Hospital. Status unknown at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-08-05.

Sponsored by The Miriam Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Overweight
  • Obesity

Browse trials for

03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's planned enrollment of 30 is below the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

The Miriam Hospital is the lead sponsor of 178 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Body mass index (BMI) between 27 and 45 kg/m\^2

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Online Weight Loss Program

    Behavioral: Online Behavioral Weight Loss program

  • Experimental
    Online Weight Loss Program + Nomogram

    Behavioral: Online Behavioral Weight Loss program · Behavioral: Weight Loss Nomogram

  • Experimental
    Online Weight Loss Program + Nomogram + Bite Counter

    Behavioral: Online Behavioral Weight Loss program · Behavioral: Weight Loss Nomogram · Behavioral: Bite Counter

Interventions

  • BehavioralOnline Behavioral Weight Loss program
  • BehavioralWeight Loss Nomogram
  • BehavioralBite Counter
06

What researchers measure

Primary outcomes

  1. Weight Loss

    Time frame: 6 months after beginning treatment

Secondary outcomes

  1. Number of online weight loss lessons viewed

    Time frame: 6 months after beginning treatment

  2. Number of weeks body weight, caloric intake, and physical activity reported online

    Time frame: 6 months after beginning treatment

  3. Number of weekly clinic visits attended

    Time frame: 6 months after beginning treatment

  4. Average number of bites of food per day

    Time frame: 6 months after beginning treatment

07

Study locations

1 of 1 sites recruiting
  • Miriam Hospital Weight Control and Diabetes Resarch Center
    Providence, Rhode Island 02903, United States
    • Graham Thomas, PhD · Contact · jthomas4@lifespan.org · 401-793-8154
    • Graham Thomas, PhD · Principal investigator
    • Dale Bond, PhD · Sub investigator
    • Carly Goldstein, PhD · Sub investigator
    • Diana Thomas, PhD · Sub investigator
    Recruiting
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02857595
Lead sponsor
The Miriam Hospital
Responsible party
John Graham Thomas (Associate Professor (Research), The Miriam Hospital) — Principal investigator
First posted
Aug 5, 2016
Start date
Jul 2016
Primary completion
Jul 2017 (estimated)
Last update
Aug 5, 2016

Study contacts

Graham Thomas, PhD
Contact
jthomas4@lifespan.org
4017938154
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion