Bariatric Scalable Internet Treatments

Not Applicable

Completed

• Conditions: Bariatric Surgery; Weight Loss
• Interventions: Behavioral: Guided Self-Help Behavioral Weight Loss

• Registration Number: NCT03680703
• Lead Sponsor: Yale University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-20
• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-09-19
• Study First Posted: 2018-09-21
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet	Guided Self-Help Behavioral Weight Loss	Guided self-help behavioral weight loss treatment delivered via the internet
Internet Plus Phone	Guided Self-Help Behavioral Weight Loss	Guided self-help behavioral weight loss treatment delivered via the internet with weekly phone consultations

Primary Outcome Measures

Name	Time	Method
Weight Change	3 months	Percent weight loss (in pounds) from baseline.

Trial Locations

Locations (1)

Yale Department of Psychiatry; 🇺🇸 New Haven, Connecticut, United States