An interventional study of Home weight loss program in Overweight and Obesity, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-09.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
The goal of the project is to test a remotely delivered, standalone behavioral weight loss intervention designed to help adults initiate the important dietary, physical activity (PA) and behavioral changes necessary to achieve weight loss.
The Weight Management Center currently offers a remotely delivered (smart phone, tablet, computer) program to assist patients with maintaining weight losses already achieved, which includes multi-channel self-monitoring and asynchronous individually recorded feedback from clinical staff. The goal of the presently proposed project is to build on this existing maintenance-focused program to create a remotely delivered, standalone behavioral weight loss intervention designed to help participants initiate the important dietary, physical activity (PA) and behavioral changes necessary to achieve weight loss. We recently developed the Home Weight Loss (HWL) program by repackaging existing clinical educational materials as instructional lifestyle change modules to be delivered remotely for participant weight loss
The aim of the proposed project are to pilot test the effects of the HWL program among a sample of overweight and obese adults (N=30). The digital platform currently used in the maintenance program will be used for the HWL program
3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.
This study's enrollment of 30 is below the median of 73 across 3,263 interventional studies indexed under Overweight.
Browse Overweight studies →Medical University of South Carolina is the lead sponsor of 871 studies on the registry; 163 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will be instructed to daily monitor their body weight, minutes of activity, number of steps, and calories consumed for the duration of the pilot study, and they will receive recorded individualized feedback on this self-monitored data from Weight Management Center clinicians (registered dietitians, exercise psychologists, and behavioral specialists).
Behavioral: Home weight loss program
Patient remote self-monitoring of diet, activity, and weight with clinician feedback provided remotely based on self-monitored data.
Body weight change
body weight change (kg) from pre-to post
Time frame: 12 weeks
changes in body weight as a percentage of start weight
percent body weight change
Time frame: 12 weeks
changes in body mass index
weight in kgs divided by height in meters squared to obtain BMI (kg/m\^2)
Time frame: 12 weeks
program satisfaction
program satisfaction obtained from multiple choice items developed by study staff. Subjects are asked to rate their level of agreement with items assessing their satisfaction with the overall program, available responses range from extremely satisfied to not at all satisfied.
Time frame: 12 weeks
changes in body fat percentage
changes in body fat percentage
Time frame: 12 weeks
changes in waist and hip measurements
changes in waist and hip measurements
Time frame: 12 weeks
usability of program components
examine usage of tracking components including step, exercise, diet, and weight tracking
Time frame: 12 weeks
changes in eating behavior scores
use of the Eating Behavior Inventory (EBI). This is a validated 26-item scale assessing eating and weight control behaviors. Subjects indicate agreement with statements with reponse options ranging in values from 1 (never or hardly ever) to 5 (always or almost). Higher values are indicative of those most associated with weight loss (e.g., self-monitoring caloric intake) and are therefore associated with better weight loss outcomes following behavioral weight management intervention.
Time frame: 12 weeks
changes in scores on the power of food scale
use of the Power of Food Scale (PFS). This is a validated 15-item scale with responses scored and ranging between 1 (do not agree) and 5 (strongly agree) with the statements. Higher scores indicate less favorable outcomes, as higher scores indicate increased patient susceptibility to food in the environment.
Time frame: 12 weeks
Plan to share: No — No individual data is planned to be shared with other researchers.
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Jul 2018, 4 months.
Of 1,356 non-industry interventional studies with no phase under Overweight, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's 4 months is below that.
Counting every sponsor, half of 1,472 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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