ClinicalTrials.gg
CompletedNCT03680703Updated Jan 7, 2020

Bariatric Scalable Internet Treatments

An interventional study of Guided Self-Help Behavioral Weight Loss in Bariatric Surgery and Weight Loss, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-01-07.

Sponsored by Yale University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Bariatric Surgery
  • Weight Loss

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03

In context

Weight Loss

1,818 studies on the registry are indexed under Weight Loss; 286 are open to participants now.

This study's enrollment of 33 is below the median of 73 across 1,540 interventional studies indexed under Weight Loss.

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Lead sponsor

Yale University is the lead sponsor of 1,763 studies on the registry; 292 are open to participants now.

Of its 217 completed or terminated interventional studies of FDA-regulated products, 128 (59%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Internet

    Guided self-help behavioral weight loss treatment delivered via the internet

    Behavioral: Guided Self-Help Behavioral Weight Loss

  • Experimental
    Internet Plus Phone

    Guided self-help behavioral weight loss treatment delivered via the internet with weekly phone consultations

    Behavioral: Guided Self-Help Behavioral Weight Loss

Interventions

  • BehavioralGuided 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.

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What researchers measure

Primary outcomes

  1. Weight Change

    Percent weight loss (in pounds) from baseline.

    Time frame: 3 months

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Study locations

1 site
  • Yale Department of Psychiatry
    New Haven, Connecticut 06510, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03680703
Lead sponsor
Yale University
Responsible party
Sponsor
First posted
Sep 21, 2018
Start date
Jul 20, 2018
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Jan 7, 2020

Study contacts

Valentina Ivezaj, Ph.D.
principal investigator · Yale University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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