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

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ClinicalTrials.gov Identifier: NCT02857595
Recruitment Status : Recruiting
First Posted : August 5, 2016
Last Update Posted : August 5, 2016
Sponsor:
Information provided by (Responsible Party):
John Graham Thomas, The Miriam Hospital

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).

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: Online Behavioral Weight Loss program Behavioral: Weight Loss Nomogram Behavioral: Bite Counter Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2016
Estimated Primary Completion Date : July 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Weight Loss [ Time Frame: 6 months after beginning treatment ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02857595


Contacts
Contact: Graham Thomas, PhD 4017938154 jthomas4@lifespan.org

Locations
United States, Rhode Island
Miriam Hospital Weight Control and Diabetes Resarch Center Recruiting
Providence, Rhode Island, United States, 02903
Contact: Graham Thomas, PhD    401-793-8154    jthomas4@lifespan.org   
Principal Investigator: Graham Thomas, PhD         
Sub-Investigator: Dale Bond, PhD         
Sub-Investigator: Carly Goldstein, PhD         
Sub-Investigator: Diana Thomas, PhD         
Sponsors and Collaborators
The Miriam Hospital

Responsible Party: John Graham Thomas, Associate Professor (Research), The Miriam Hospital
ClinicalTrials.gov Identifier: NCT02857595     History of Changes
Other Study ID Numbers: 212715 45CFR 46.110(4)(7)
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms