Recruiting

Energy Balancing

Sponsor:

The Miriam Hospital

Code:

NCT02857595

Conditions

Overweight

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Online Behavioral Weight Loss program

Weight Loss Nomogram

Bite Counter

Study Details

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).

Conditions

Overweight

Obesity

Study ID

NCT02857595

Start date

Jul, 2016

Status verified date

Aug, 2016

Primary completion date

Jul, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Online Weight Loss Program

experimental: Online Weight Loss Program + Nomogram

experimental: Online Weight Loss Program + Nomogram + Bite Counter

Interventions

Online Behavioral Weight Loss program

Weight Loss Nomogram

Bite Counter

Primary outcome measure

  • Weight Loss [ Time Frame: 6 months after beginning treatment ]

Central Contacts and Locations

Central contacts

Locations

Miriam Hospital Weight Control and Diabetes Resarch Center

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Principal Investigator:

Graham Thomas, PhD

More Information

Sponsor

The Miriam Hospital

Last update posted

Aug 5, 2016

Last verified

Aug, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Miriam Hospital on 2016-08-05.