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
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).
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 →The Miriam Hospital is the lead sponsor of 178 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Behavioral: Online Behavioral Weight Loss program
Behavioral: Online Behavioral Weight Loss program · Behavioral: Weight Loss Nomogram
Behavioral: Online Behavioral Weight Loss program · Behavioral: Weight Loss Nomogram · Behavioral: Bite Counter
Weight Loss
Time frame: 6 months after beginning treatment
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
This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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The Miriam Hospital