Pilot Study of Laparoscopic Gastric Plication in Adolescents With Severe Obesity

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Virginia Commonwealth University
Sponsor:
Collaborator:
Children's Hospital of Richmond
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01980758
First received: September 26, 2013
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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:

  1. 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.
  2. 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.

Condition Intervention
Obesity
Procedure: Laparoscopic Gastric Plication

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Laparoscopic Gastric Plication in Adolescents With Severe Obesity

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Reduction of Excess Body Weight [ Time Frame: 6 months post-surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in comorbidities to obesity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Changes in lifestyle choices [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Improvement in quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2013
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surgery
Laparoscopic Gastric Plication
Procedure: 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.

Detailed Description:

The complete study protocol, which is described in detail below, spans 3 years and includes 11 research assessment points (Pre-1, Pre-2, T0, T1, T2, T3, T4, T5, T6, T7, and T8). Please refer to Figure 2. Study Protocol from Enrollment to Post-Surgical Assessments. Select pre-treatment assessments will be conducted initially (Pre-1), followed by a 2-month pre-surgical education and lifestyle modification treatment program, consisting of four visits with psychology, nutrition, exercise, and surgery. After successful completion of this pre-surgical education program, a more comprehensive pre-surgical assessment by a surgeon (Pre-2) will be conducted. If patients decide to pursue the study, in the two weeks prior to surgery, participants will be asked to adhere to a pre-surgical diet, exclusion and inclusion criteria will be reviewed again by the study team, and verbal consent/assent will be re-confirmed with adolescents and parent(s). Following surgery (T0), comprehensive follow-up care will be provided via the multidisciplinary team at the HLC at CHoR. The follow-up period will be divided into three phases: 1) Early Post-Operative Phase (0-5 months), 2) Late Post-Operative phase (6-12 months), and 3) Long-term Follow-up Phase (13-36 months). In conjunction with clinical follow-up, repeat standardized research assessments will be conducted post-operatively at 1-2 weeks (T1), 6 weeks (T2), 3 months (T3), 6 months (T4), 12 months (T5), 18 months (T6), 24 months (T7), and 36 months (T8). Specific screening, pre-surgical, perioperative, and post-surgical study procedures at each time point are described fully below and outlined in Figure 2 and Table 1. Additionally, all research measures are described in detail in the Measures Section. If any participant requires any additional visit during the time of this study, data from these visits will also be collected for this study. Care directly related to the surgery and study will not be billed but other medical issues such as hypertension, diabetes, hypercholesterolemia and depression may require management outside of the scope of the study and will be billed accordingly

  Eligibility

Ages Eligible for Study:   14 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01980758

Contacts
Contact: Janet D Delorme, MS 804-527-4756 jdelorm@vcu.edu

Locations
United States, Virginia
Children's Hospital of Richmond at VCU Recruiting
Richmond, Virginia, United States, 23298
Contact: Janet D Delorme, MS    804-527-4756    jdelorm@vcu.edu   
Principal Investigator: David Lanning, MD, PhD         
Sub-Investigator: Melanie Bean, PhD         
Sub-Investigator: Edmond Wickham, MD         
Sub-Investigator: Claudio Oiticica, MD         
Sub-Investigator: Ronald K Evans, PhD         
Sponsors and Collaborators
Virginia Commonwealth University
Children's Hospital of Richmond
Investigators
Principal Investigator: David Lanning, MD, PhD Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01980758     History of Changes
Other Study ID Numbers: HM14809
Study First Received: September 26, 2013
Last Updated: November 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
obesity, pediatric obesity, bariatric, bariatric surgery

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014