Bariatric Scalable Internet Treatments

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to conduct a randomized clinical trial examining the feasibility and effectiveness of two guided self-help behavioral weight loss (gshBWL) treatments delivered via the internet for individuals struggling with weight loss one year following bariatric surgery. The two treatments will consist of 1) gshBWL delivered through the internet only (gshBWL-I) and 2) gshBWL delivered via the internet with additional complementary phone sessions (gshBWL-IP).

Official Title
-----------------
Randomized Clinical Trial Testing Two Scalable Internet-Based Weight Loss Treatments Following Bariatric Surgery

Conditions
-----------------
Bariatric Surgery, Weight Loss

Intervention / Treatment
-----------------
* Behavioral: Guided Self-Help Behavioral Weight Loss


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gastric bypass and sleeve surgery patients from Yale's Bariatric/Gastrointestinal Surgery Program surgery 1-2 years prior <60% excess weight loss able to read English proficiently enough to read the patient self-help materials and study assessments available for the duration of the treatment availability of internet and phone to participate in study interventions agree to the study procedures Exclusion Criteria: medical status judged by the surgeon as contraindication (rare instances of need for additional surgery or medical instability) unable to ambulate current medications that influence eating/weight current substance dependence or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet<br>Guided self-help behavioral weight loss treatment delivered via the internet | Behavioral: Guided Self-Help Behavioral Weight Loss<br>* Participants will be provided with patient-focused materials and worksheets that contain all the necessary information, procedures, and techniques of the behavioral weight loss program. For 12 weeks, treatment will be provided over the internet. This therapy focuses on making gradual and modest lifestyle changes with goals of normalizing eating patterns, decreasing caloric intake, building coping skills, and increasing physical activity.<br>|
| Experimental: Internet Plus Phone<br>Guided self-help behavioral weight loss treatment delivered via the internet with weekly phone consultations | Behavioral: Guided Self-Help Behavioral Weight Loss<br>* Participants will be provided with patient-focused materials and worksheets that contain all the necessary information, procedures, and techniques of the behavioral weight loss program. For 12 weeks, treatment will be provided over the internet. This therapy focuses on making gradual and modest lifestyle changes with goals of normalizing eating patterns, decreasing caloric intake, building coping skills, and increasing physical activity.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Change | Percent weight loss (in pounds) from baseline. | 3 months |