Addressing Anxiety and Stress for Healthier Eating in Teens (ASSET)

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.

Study Overview

• Status: Recruiting
• Conditions: Mental Disorders; Obesity; Feeding and Eating Disorders; Overweight; Body Weight; Anxiety; Eating Behavior
• Intervention / Treatment: Behavioral: Interpersonal Psychotherapy (IPT); Behavioral: Cognitive Behavioral Theory (CBT)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natalia Sanchez, MPH; Phone Number: 970-491-1120; Email: natalia.sanchez@colostate.edu
• Study Contact Backup: Name: Alexander Rice, PhD; Phone Number: 310-845-5058; Email: alexander.rice.ctr@usuhs.edu

Study Locations

• United States
  • Colorado
    • Fort Collins, Colorado, United States, 80523-1570
      • Recruiting
      • Colorado State University
      • Contact: Natalia Sanchez; Phone Number: 970-491-1120; Email: Natalia.Sanchez@colostate.edu
      • Principal Investigator: Lauren Shomaker, PhD
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Recruiting
      • Uniformed Services University
      • Contact: Alexander Rice, PhD; Phone Number: 310-845-5058; Email: alexander.rice.ctr@usuhs.edu
      • Contact: Julia Gallagher-Teske, BS; Phone Number: 301-400-4401; Email: julia.gallagher-teske.ctr@usuhs.edu
      • Principal Investigator: Mairan Tanofsky-Kraff, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Interpersonal Psychotherapy (IPT); The IPT group sessions follow three phases (initial, middle, and termination) and use the interpersonal inventory to identify interpersonal problems that might be contributing to or exacerbating disinhibited eating and anxiety symptoms. A framework of common problem areas is used to teach interpersonal problem-solving and communication skills and educate youth about risk factors and warning signs for excessive weight gain, such as eating in response to negative affect as opposed to hunger, or feeling a sense of loss-of-control while eating. IPT focuses on psychoeducation and general skill-building that can be applied to different relationships within the framework of four interpersonal problem areas: interpersonal role disputes, role transitions, interpersonal deficits, and grief.
Active Comparator: Cognitive-Behavioral Therapy (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.	Behavioral: Cognitive Behavioral Theory (CBT); The CBT program will be derived from Coping Cat, a manualized intervention for children and adolescents with elevated symptoms of anxiety. The group intervention builds skills for managing anxiety, in general, but with a focus on how anxiety prompts disinhibited eating, including attention to and restructuring of negative cognitions that perpetuate anxiety and behavioral exposure, rather than avoidance, of anxiety-provoking situations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Fidelity and Acceptability	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	Entirety of the Study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Disinhibited Eating	Eating Disorder Examination Interview- overeating section will be administered to assess for the presence of overeating with and without loss of control.	Post-Treatment
Mood/Anxiety, Eating, And Social Functioning	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).	Post Treatment
Participant Height, Weight, and Blood Pressure	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.	Post Treatment
Body Composition Measurement	Assessed using air displacement plethysmography (Bod Pod).	Post treatment
Collection of Metabolic Markers	Blood will be drawn in a fasted state to measure glucose, insulin, and lipids.	Post Treatment
Parental report of eating behaviors	Parents/guardians will be asked to complete Eating in the Absence of Hunger Questionnaire for Children - Parent Report (EAH-C Parent).	Post Treatment
Cardiometabolic Functioning	Measured by blood draw, continuous glucose monitoring, and heart rate, sleep and activity via Carnation Ambulatory Monitor.	Post Treatment
Movement and Activity	Measured by ActivPal monitoring device	Post Treatment

Collaborators and Investigators

• Sponsor: The Metis Foundation
• Collaborators: Colorado State University

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2021
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Adolescent; Obesity; Anxiety; Overweight; Prevention; Cognitive Behavioral Therapy; Interpersonal Psychotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Anxiety Disorders; Feeding and Eating Disorders; Mental Disorders; Overweight; Body Weight
• Other Study ID Numbers: USUHS.2020-048

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No