Clinical trial NCT05038033: Addressing Anxiety and Stress for Healthier Eating in Teens
Official title: Addressing Anxiety and Stress for Healthier Eating in Teens
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Overweight
Anxiety
Mental Disorders
Body Weight
Eating Behavior
Feeding and Eating Disorders
Keywords: Obesity
Overweight
Anxiety
Adolescent
Prevention
Interpersonal Psychotherapy
Cognitive Behavioral Therapy
Lead sponsor: The Metis Foundation
Sponsor class: OTHER
Collaborators: name: Colorado State University
First posted: 2021-09-08
Enrollment: 40
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with two treatment arms and two intervention cohorts across two sites.
Primary purpose: PREVENTION

Brief summary: Project ASSET will explore the preliminary efficacy of interpersonal therapy, when compared with cognitive behavioral therapy, for reducing anxiety symptoms, preventing excess weight gain, and reducing cardio-metabolic risk in adolescent girls with above-average weight and elevated anxiety. As a pilot for a larger multi-site study, this trial will also test multi-site feasibility, acceptability, and intervention fidelity.

Detailed description: This study is a randomized controlled trial in which 40 adolescent girls aged 12-17 years-old with weight in the 75th percentile or higher for their age and sex, and elevated anxiety symptoms, will be randomly assigned to an IPT or CBT 12-week group intervention. Approximately 20 adolescent girls will be enrolled at each of two sites: Uniformed Services University (USU) and Colorado State University (CSU). After a screening and baseline assessment, participants will attend an individual meeting with the leaders of their assigned group to learn more about the group process and establish goals. They will then participate in the group program for 12 consecutive weeks. Each group will be led by a PhD-level clinical psychologist and a healthcare trainee. In-person and remote assessments, will be conducted at baseline, in the \~two weeks post-intervention (i.e., 12-week follow-up), and at 1, 2, and 3 years post-intervention. These assessments will consist of body measurements, blood draws for collection markers of metabolic functioning, and surveys and interviews of psychological and social functioning. At baseline, two weeks, and one year post-intervention, participants will also have a week-long period during which they will wear devices collecting activity and physiological data, and complete phone surveys assessing disinhibited eating behaviors, food craving, affect, cognitions, and avoidance behaviors.

Eligibility criteria: Participant Inclusion Criteria:

* 12-17-year-old adolescent girls
* BMI ≥ 75th percentile
* Anxiety symptoms: 32 or higher on State Trait Anxiety Inventory for Children-Trait Scale

Participant Exclusion Criteria:

* Any medical condition (as well as pregnancy or breastfeeding)
* Individuals who have any DSM psychiatric disorder that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study
* Medication impacting mood or weight
* Psychotherapy

Primary outcomes:
measure: Intervention Fidelity and Acceptability
timeFrame: Entirety of the Study
Secondary outcomes:
measure: Presence of Disinhibited Eating
timeFrame: Post-Treatment
measure: Mood/Anxiety, Eating, And Social Functioning
timeFrame: Post Treatment
measure: Participant Height, Weight, and Blood Pressure
timeFrame: Post Treatment
measure: Body Composition Measurement
timeFrame: Post treatment
measure: Collection of Metabolic Markers
timeFrame: Post Treatment
measure: Parental report of eating behaviors
timeFrame: Post Treatment
measure: Cardiometabolic Functioning
timeFrame: Post Treatment
measure: Movement and Activity
timeFrame: Post Treatment
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
city: Bethesda
country: United States
facility: Uniformed Services University
state: Maryland
Study officials:
References: