Back to resultsBariatric Scalable Internet Treatments
Primary Purpose
Bariatric Surgery, Weight Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided Self-Help Behavioral Weight Loss
Sponsored by
About this trial
This is an interventional treatment trial for Bariatric Surgery
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.
Sites / Locations
- Yale Department of Psychiatry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Internet
Internet Plus Phone
Arm Description
Guided self-help behavioral weight loss treatment delivered via the internet
Guided self-help behavioral weight loss treatment delivered via the internet with weekly phone consultations
Outcomes
Primary Outcome Measures
Weight Change
Percent weight loss (in pounds) from baseline.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03680703
Brief Title
Bariatric Scalable Internet Treatments
Official Title
Randomized Clinical Trial Testing Two Scalable Internet-Based Weight Loss Treatments Following Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 20, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery, Weight Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet
Arm Type
Experimental
Arm Description
Guided self-help behavioral weight loss treatment delivered via the internet
Arm Title
Internet Plus Phone
Arm Type
Experimental
Arm Description
Guided self-help behavioral weight loss treatment delivered via the internet with weekly phone consultations
Intervention Type
Behavioral
Intervention Name(s)
Guided Self-Help Behavioral Weight Loss
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight Change
Description
Percent weight loss (in pounds) from baseline.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valentina Ivezaj, Ph.D.
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Department of Psychiatry
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bariatric Scalable Internet Treatments
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