Pilot Study of the HWL Program (HWL)
|ClinicalTrials.gov Identifier: NCT03439579|
Recruitment Status : Completed
First Posted : February 20, 2018
Last Update Posted : November 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Overweight and Obesity||Behavioral: Home weight loss program||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single group pilot study|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of the Home Weight Loss Program|
|Actual Study Start Date :||February 6, 2018|
|Actual Primary Completion Date :||July 3, 2018|
|Actual Study Completion Date :||September 21, 2018|
Experimental: Home weight loss program
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 [ Time Frame: 12 weeks ]body weight change (kg) from pre-to post
- changes in body weight as a percentage of start weight [ Time Frame: 12 weeks ]percent body weight change
- changes in body mass index [ Time Frame: 12 weeks ]weight in kgs divided by height in meters squared to obtain BMI (kg/m^2)
- program satisfaction [ Time Frame: 12 weeks ]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.
- changes in body fat percentage [ Time Frame: 12 weeks ]changes in body fat percentage
- changes in waist and hip measurements [ Time Frame: 12 weeks ]changes in waist and hip measurements
- usability of program components [ Time Frame: 12 weeks ]examine usage of tracking components including step, exercise, diet, and weight tracking
- changes in eating behavior scores [ Time Frame: 12 weeks ]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.
- changes in scores on the power of food scale [ Time Frame: 12 weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439579
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Patrick M O'Neil, PhD||Medical University of South Carolina|