Bariatric Scalable Internet Treatments

NCT ID: NCT03680703

Last Updated: 2020-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-20

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Bariatric Surgery Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Internet

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

Group Type EXPERIMENTAL

Guided Self-Help Behavioral Weight Loss

Intervention Type 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.

Internet Plus Phone

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

Group Type EXPERIMENTAL

Guided Self-Help Behavioral Weight Loss

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valentina Ivezaj, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale Department of Psychiatry

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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2000023155

Identifier Type: -

Identifier Source: org_study_id

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