Evaluation of a Family-based Pediatric Obesity Program: TEENS+

Investigators will recruit overweight or obese adolescents (BMI >85th percentile) and
parent(s) (BMI >25 kg/m2). Families will participate in one of two 6-month treatments: 1)
TEENS+Parents as Coaches (PAC), engaging parents as helpers in their child's weight
management, or 2) TEENS+Parent Weight Loss (PWL), engaging parents in their own weight
management. All adolescents will participate in TEENS+, which includes behavioral support,
nutrition education, and supervised physical activity.

For the adolescents, intervention will consist of weekly 1 hour exercise sessions and
alternating weekly 1 hour behavioral and nutrition group sessions. Parents will also attend
the nutrition sessions and participate in a behavioral parent-only biweekly group. Parent
behavioral group sessions will be specific to the treatment arm (e.g. PAC or PWL).
Assessments will consist of anthropometric measures, lab work, psychological surveys, and
nutritional evaluations. Assessments will be completed at baseline, 3 months, 6 months
(post-intervention), and 9 months.

Inclusion Criteria: Overweight (BMI ≥85% percentile for age and gender according to the
CDC Growth Charts) males and females between the age of 12 and 17 years will be eligible
for study participation. In order to be eligible, the adolescent must also reside with the
primary participating parent, who has a BMI ≥25 kg/m 2 and is also willing to participate
in the study protocol. Eligible families must live within a 30 mile radius of the Healthy
Lifestyles Center (HLC) at Children's Hospital of Richmond (CHoR) at VCU where the
interventions will be conducted.

Exclusion Criteria:

Adolescents and parents will be ineligible for study participation under the following
conditions: 1) non-English speaking; 2) medical condition(s) that may be associated with
unintentional weight change (e.g., hypothalamic injury, Prader-Willi, or malignancy); 3)
diabetes mellitus diagnosed by history or a fasting glucose ≥126 mg/dl (subjects with
glucose intolerance or "pre-diabetes" will eligible for study participation); 4) use of
oral glucocorticoids, atypical antipsychotics, weight loss medications, or an
investigational medication within 3 months of study participation; 5) medical condition(s)
that may be negatively impacted by exercise; 6) physical limitation affected the ability
to exercise, 7) psychiatric, cognitive or developmental conditions that would impair the
adolescent's ability to complete assessments or participate in a group; 8) reports of
compensatory behaviors (i.e., vomiting, laxative abuse, excessive exercise) in the past 3
months; 9) current pregnancy or plan to become pregnant during study period; 10) previous
participation in TEENS or NOURISH; 11) current participation in another weight loss
program; or 12) personal history of weight loss surgery.

Adolescents and parents taking metformin, oral contraceptives, tricyclic antidepressants
(TCAs), selective serotonin reuptake inhibitors (SSRIs), or stimulant medications may be
eligible for participation; however, subjects must be on a stable dose of medication for
at least 3 months prior to study participation.

In addition, adolescents will be excluded from participation (and referred for further
evaluation) based on the results of baseline psychological assessments under the following
circumstances: 1) clinically significant depression, evidenced by elevations (>20) on CDI;
2) suicidality as reported on CDI or during screening / behavioral interview; 3)
psychosis, 4) clinical impairment in Activities of Daily Living and Functional
Communication (i.e., expressive and receptive communication; and 3) clinically significant
eating disorder based on EDE-Q.