Pilot Study of the HWL Program

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Pilot Study of the Home Weight Loss Program

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: Home weight loss program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 18-70 years BMI = 25.0- 40 kg/m2 Internet access via desktop or laptop computer valid email address smart phone ownership women of childbearing potential must agree to use effective contraception during the study Exclusion Criteria: currently dieting (>10-pound weight loss in past 3 months) another member of the household is participating in this pilot study inability to engage in physical activity inability to read and speak English diagnosis of diabetes (other than treated by diet alone), uncontrolled thyroid condition or other endocrine disorder major depressive disorder or other severe psychiatric disorder (e.g., bipolar disorder) within the past two years past suicide attempt current use of prescription or over-the-counter weight loss medications current/planned pregnancy drug and/or alcohol abuse use of steroid medication for more than 10 days in the past three months *implanted electronic devices

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single group pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home weight loss program<br>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<br>* Patient remote self-monitoring of diet, activity, and weight with clinician feedback provided remotely based on self-monitored data.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight change | body weight change (kg) from pre-to post | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in body weight as a percentage of start weight | percent body weight change | 12 weeks | 
| changes in body mass index | weight in kgs divided by height in meters squared to obtain BMI (kg/m^2) | 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. | 12 weeks | 
| changes in body fat percentage | changes in body fat percentage | 12 weeks | 
| changes in waist and hip measurements | changes in waist and hip measurements | 12 weeks | 
| usability of program components | examine usage of tracking components including step, exercise, diet, and weight tracking | 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. | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telehealth, Remote weight loss, Self-monitoring, Diet, Physical activity