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OpenTrials
Completed

NCT Number: NCT03680703

Bariatric Scalable Internet Treatments

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).

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Key information

Conditions

Bariatric Surgery Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale Department of Psychiatry

New Haven, Connecticut, 06510, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guided Self-Help Behavioral Weight Loss

Behavioral

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 outcomes

  1. Weight Change

    Time frame: 3 months

    Percent weight loss (in pounds) from baseline.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 21, 2018
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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