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

August 2, 2016 updated by: John Graham Thomas, The Miriam Hospital
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Miriam Hospital Weight Control and Diabetes Resarch Center
        • Contact:
        • Principal Investigator:
          • Graham Thomas, PHD
        • Sub-Investigator:
          • Dale Bond, PhD
        • Sub-Investigator:
          • Carly Goldstein, PhD
        • Sub-Investigator:
          • Diana Thomas, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight Loss
Time Frame: 6 months after beginning treatment
6 months after beginning treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of online weight loss lessons viewed
Time Frame: 6 months after beginning treatment
6 months after beginning treatment
Number of weeks body weight, caloric intake, and physical activity reported online
Time Frame: 6 months after beginning treatment
6 months after beginning treatment
Number of weekly clinic visits attended
Time Frame: 6 months after beginning treatment
6 months after beginning treatment
Average number of bites of food per day
Time Frame: 6 months after beginning treatment
6 months after beginning treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Miriam Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimate)

August 5, 2016

Study Record Updates

Last Update Posted (Estimate)

August 5, 2016

Last Update Submitted That Met QC Criteria

August 2, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 212715 45CFR 46.110(4)(7)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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