Pilot Study of Laparoscopic Gastric Plication in Adolescents With Severe Obesity

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

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.