Bariatric Scalable Internet Treatments

NCT03680703 | Completed

• 1 other identifier: 2000023155
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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).

Conditions

Bariatric Surgery; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Weight Change

  Percent weight loss (in pounds) from baseline.

  3 months

Study Arms (2)

Internet

EXPERIMENTAL

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

Behavioral: Guided Self-Help Behavioral Weight Loss

Internet Plus Phone

EXPERIMENTAL

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

Behavioral: Guided Self-Help Behavioral Weight Loss

Interventions

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.

Internet; Internet Plus Phone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Department of Psychiatry

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Valentina Ivezaj, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 21, 2018
• Study Start: July 20, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

US (1)