Bariatric Scalable Internet Treatments

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03680703
• Other study ID #: 2000023155
• Status: Completed
• Phase: N/A
• Start date: July 20, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery
• Weight Loss

Intervention

Behavioral:
• Guided Self-Help Behavioral Weight Loss
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.

Locations

Country	Name	City	State
United States	Yale Department of Psychiatry	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Change	Percent weight loss (in pounds) from baseline.	3 months