Addressing Anxiety and Stress for Healthier Eating in Teens
- Conditions
- Body WeightAnxietyObesityOverweightMental DisordersEating BehaviorFeeding and Eating Disorders
- Interventions
- Behavioral: Interpersonal Psychotherapy (IPT)Behavioral: Cognitive Behavioral Theory (CBT)
- Registration Number
- NCT05038033
- Lead Sponsor
- The Metis Foundation
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 40
- 12-17-year-old adolescent girls
- BMI ≥ 75th percentile
- Anxiety symptoms: 32 or higher on State Trait Anxiety Inventory for Children-Trait Scale
Participant
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Interpersonal Psychotherapy (IPT) Interpersonal Psychotherapy (IPT) Interpersonal Psychotherapy program adapted for the prevention of excessive weight gain. Involves one initial 1.5-hour individual session, and 12 weekly 90-minute group sessions. Cognitive-Behavioral Therapy (CBT) Cognitive Behavioral Theory (CBT) The CBT program will match the delivery format and dose of the IPT program. There will be one initial 1.5-hour individual session, and 12 weekly 90-minute group sessions.
- Primary Outcome Measures
Name Time Method Intervention Fidelity and Acceptability Entirety of the Study Feasibility: Fidelity ratings of facilitators' competence/adherence in administration of IPT and CBT; CONSORT tracking of recruitment, recruitment rate and percentage of eligible adolescents who enroll as recorded by study coordinators; median sessions attended and home practice completion, as recorded by facilitators; CONSORT tracking of follow-up retention as recorded by study coordinators; and completeness of data collection.
Acceptability: Adolescent self-reports on program and monitor acceptability questionnaires
- Secondary Outcome Measures
Name Time Method Mood/Anxiety, Eating, And Social Functioning Post Treatment Adolescent self-reports on mood and eating as well as psychological distress via questionnaire, interview, and smartphone surveys.
Assesed through completion of surveys: Center For Epidemiologic Studies - Depression Scale (CES-D), Social Phobia And Anxiety Inventory For Children (SPAI-C), Emotional Eating Scale - Children, Social Adjustment Scale-self Report, Difficulties In Emotion Regulation Scale-short Form, Conflict Behavior Questionnaire, Network Of Relationships Inventory-short Form, Children's Automatic Thoughts Scale (CATS-N/P), Anxiety Control Questionnaire For Children (ACQ-C), The Self-efficacy Questionnaire For Children (SEQ-C), Children's Coping Strategies Checklist - Revised (CCSC-R1), Positive And Negative Affect Schedule - Child Form (PANAS-C).Presence of Disinhibited Eating Post-Treatment Eating Disorder Examination Interview- overeating section will be administered to assess for the presence of overeating with and without loss of control.
Participant Height, Weight, and Blood Pressure Post Treatment Weight will be measured via scale and height via stadiometer. This will be used to calculate BMI percentile. Blood pressure assessed via digital blood pressure monitor.
Body Composition Measurement Post treatment Assessed using air displacement plethysmography (Bod Pod).
Collection of Metabolic Markers Post Treatment Blood will be drawn in a fasted state to measure glucose, insulin, and lipids.
Parental report of eating behaviors Post Treatment Parents/guardians will be asked to complete Eating in the Absence of Hunger Questionnaire for Children - Parent Report (EAH-C Parent).
Cardiometabolic Functioning Post Treatment Measured by blood draw, continuous glucose monitoring, and heart rate, sleep and activity via Carnation Ambulatory Monitor.
Movement and Activity Post Treatment Measured by ActivPal monitoring device
Trial Locations
- Locations (2)
Colorado State University
🇺🇸Fort Collins, Colorado, United States
Uniformed Services University
🇺🇸Bethesda, Maryland, United States