Bariatric SurgeryNCT03680703
Bariatric Scalable Internet Treatments
A study testing Guided Self-Help Behavioral Weight Loss in people with Bariatric Surgery and Weight Loss, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bariatric Surgery, Weight Loss
- What is being tested?
- Guided Self-Help Behavioral Weight Loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Department of Psychiatry
New Haven, Connecticut, 06510
About this study
Official title: Randomized Clinical Trial Testing Two Scalable Internet-Based Weight Loss Treatments Following Bariatric Surgery
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
- Being tested
- Guided Self-Help Behavioral Weight Loss
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Self-Help Behavioral Weight LossBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Internet | Experimental | Guided self-help behavioral weight loss treatment delivered via the internet Receives: 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 Receives: Behavioral: Guided Self-Help Behavioral Weight Loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Change
Percent weight loss (in pounds) from baseline.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start20 Jul 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valentina Ivezaj, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680703
- Sponsor's protocol ID
- 2000023155
- Status last verified
- Jan 2020
- First submitted
- 18 Sep 2018
- Last updated
- 7 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Testing Two Scalable Internet-Based Weight Loss Treatments Following Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03680703
- Acronym / sponsor ID
- 2000023155
- Conditions
- Bariatric Surgery, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 21 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet | Experimental | Behavioral: Guided Self-Help Behavioral Weight LossGuided self-help behavioral weight loss treatment delivered via the internet |
| Internet Plus Phone | Experimental | Behavioral: Guided Self-Help Behavioral Weight LossGuided self-help behavioral weight loss treatment delivered via the internet with weekly phone consultations |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Self-Help Behavioral Weight LossParticipants 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. | Behavioural | Internet, Internet Plus Phone |
Primary outcome
Weight Change
Time frame: 3 months
Percent weight loss (in pounds) from baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valentina Ivezaj, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Self-Help Behavioral Weight Loss in people with Bariatric Surgery and Weight Loss, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Change (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.