- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01980758
Pilot Study of Laparoscopic Gastric Plication in Adolescents With Severe Obesity
The proposed study aims to investigate the effects of laparoscopic gastric plication (LGP) on excess body weight, body mass index, and weight-related medical and psychological co-morbidities in obese adolescents. Additionally, we will evaluate the safety and efficacy of this procedure (implemented within a multidisciplinary comprehensive lifestyle modification program) on changes in the patients' medical status, psychosocial and psychological functioning, physical fitness, and health-related quality of life.
Study hypothesis:
- Laparoscopic gastric plication performed on carefully selected obese adolescents within a multidisciplinary treatment program providing pre and post-surgical behavioral and psychological support and education will result in: a) initial and sustained reductions in excess body weight and body mass index, b) improvements in psychological functioning, physical fitness, and health-related quality of life, and c) reduction in weight-related comorbidities.
- LGP will be a safe procedure, with complication rates that are comparable to or lower than what has been found in other published reports of surgical weight loss procedures used in obese adolescents.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Children's Hospital of Richmond at VCU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 14 - 19.
- At physical maturity.
- BMI of greater than or equal to 35 kg/m2 with major comorbidities, or BMI of greater than 40 kg/m2 with other weight related comorbidities.
- Must have undergone comprehensive pre-surgical assessments by a multi-disciplinary team.
- Must have at least 6 months of medically observed and attempted non-surgical weight loss.
- Must have demonstrated suboptimal weight loss following participation in a lifestyle intervention.
- Must have parents involved in all phases of recruitment and intervention.
Exclusion Criteria:
- Underlying genetic or endocrine disorder, which would preclude weight loss through behavioral and surgical techniques.
- Less than six months of participation in a medically-supervised weight management efforts.
- Active untreated, unstable psychopathology (to include active psychosis, severe depression, or significant eating pathology), as determined by psychological evaluation.
- Active suicidal ideation, as determined by psychological evaluation.
- Inadequate social support, as determined by psychological evaluation.
- Inability to provide informed consent/assent, as evidenced by clinical interview and cognitive assessments.
- Severe mental retardation, as evidenced by clinical interview and cognitive assessments.
- Demonstrated pattern of poor adherence to medical regimen and lifestyle modification.
- Active substance abuse, including tobacco use, as demonstrated by clinical interview and psychological evaluation. Inadequate knowledge of risks and patient responsibilities, as determined by clinical interview and knowledge quiz.
- Reported pregnancy within the past year, current pregnancy, or planning to become pregnant in the next three years.
- History or clinical symptoms of severe gastrointestinal reflux disease (GERD)
- Person is not deemed for medical reasons to be a surgical candidate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Surgery
Laparoscopic Gastric Plication
|
The study will examine the effects of a type of weight loss surgery on obese adolescents age 14-19.
) The study protocol includes pre-treatment assessments followed by a 2-month education and lifestyle modification treatment program.
Following surgery, comprehensive follow-up care will be provided over a 3 year period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of Excess Body Weight
Time Frame: 6 months post-surgery
|
6 months post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction in comorbidities to obesity
Time Frame: 6 months
|
6 months
|
Changes in lifestyle choices
Time Frame: 1 year
|
1 year
|
Improvement in quality of life
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David Lanning, MD, PhD, Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM14809
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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