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Bariatric Scalable Internet Treatments

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03680703
Enrollment
33
Registered
2018-09-21
Start date
2018-07-20
Completion date
2019-12-31
Last updated
2020-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery, Weight Loss

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).

Interventions

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.

Sponsors

Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Weight Change3 monthsPercent weight loss (in pounds) from baseline.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026