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Bariatric Scalable Internet Treatments

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ClinicalTrials.gov Identifier: NCT03680703
Recruitment Status : Completed
First Posted : September 21, 2018
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Bariatric Surgery Weight Loss Behavioral: Guided Self-Help Behavioral Weight Loss Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Testing Two Scalable Internet-Based Weight Loss Treatments Following Bariatric Surgery
Actual Study Start Date : July 20, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Internet
Guided self-help behavioral weight loss treatment delivered via the internet
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.

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
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 Measures :
  1. Weight Change [ Time Frame: 3 months ]
    Percent weight loss (in pounds) from baseline.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680703


Locations
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United States, Connecticut
Yale Department of Psychiatry
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Valentina Ivezaj, Ph.D. Yale School of Medicine
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03680703    
Other Study ID Numbers: 2000023155
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight