ObesityNCT01980758
Pilot Study of Laparoscopic Gastric Plication in Adolescents With Severe Obesity
A study testing Laparoscopic Gastric Plication in people with Obesity, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Obesity
- What is being tested?
- Laparoscopic Gastric Plication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to 8 Mar 2018
- 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 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Richmond at VCU
Richmond, Virginia, 23298
About this study
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.
Read the 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 Healthy Lifestyles Center (HLC) at Children's Hospital of Richmond at Virginia Commonwealth University (CHoR at VCU). 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
- Conditions
- Obesity
- Being tested
- Laparoscopic Gastric Plication
- Keywords
- obesity, pediatric obesity, bariatric, bariatric surgery
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Gastric PlicationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Laparoscopic Gastric Plication Receives: Procedure: Laparoscopic Gastric Plication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Excess Body Weight
Measured: 6 months post-surgery
Secondary outcomes (3)
Reduction in comorbidities to obesity
Measured: 6 months
Changes in lifestyle choices
Measured: 1 year
Improvement in quality of life
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startMay 2013
- Primary completion8 Mar 2018
- Study completion8 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Richmond
- Responsible party
- Sponsor
- Investigators
- David Lanning, MD, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980758
- Sponsor's protocol ID
- HM14809
- Status last verified
- Jul 2018
- First submitted
- 26 Sep 2013
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Laparoscopic Gastric Plication in Adolescents With Severe Obesity
- ClinicalTrials.gov ID
- NCT01980758
- Acronym / sponsor ID
- HM14809
- Conditions
- Obesity
- Keywords
- obesity, pediatric obesity, bariatric, bariatric surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Richmond
- Study start
- May 2013
- Primary completion
- 8 Mar 2018 (actual)
- Study completion
- 8 Mar 2018 (actual)
- First posted
- 11 Nov 2013 (estimated)
- 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 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.
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 Healthy Lifestyles Center (HLC) at Children's Hospital of Richmond at Virginia Commonwealth University (CHoR at VCU). 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Procedure: Laparoscopic Gastric PlicationLaparoscopic Gastric Plication |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
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 |
|---|---|---|
| Laparoscopic Gastric PlicationThe 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. | Procedure or surgery | Surgery |
Primary outcome
Reduction of Excess Body Weight
Time frame: 6 months post-surgery
3 secondary outcomes
Reduction in comorbidities to obesity
Time frame: 6 months
Changes in lifestyle choices
Time frame: 1 year
Improvement in quality of life
Time frame: 3 years
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 10 Jul 2018.
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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.
David Lanning, MD, PhD principal investigator
Virginia Commonwealth 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 Laparoscopic Gastric Plication in people with Obesity, run by Virginia Commonwealth 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 12 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 10 Jul 2018. 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?
Reduction of Excess Body Weight (time frame: 6 months post-surgery). 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 10 Jul 2018.