Addressing Anxiety and Stress for Healthier Eating in Teens
ASSET
1 other identifier
interventional
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Feb 2021
Typical duration for not_applicable obesity
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 22, 2021
CompletedFirst Submitted
Initial submission to the registry
August 31, 2021
CompletedFirst Posted
Study publicly available on registry
September 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedSeptember 8, 2021
August 1, 2021
3.2 years
August 31, 2021
August 31, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Presence of Disinhibited Eating
Post-Treatment
Mood/Anxiety, Eating, And Social Functioning
Post Treatment
Participant Height, Weight, and Blood Pressure
Post Treatment
Body Composition Measurement
Post treatment
Collection of Metabolic Markers
Post Treatment
- +3 more secondary outcomes
Study Arms (2)
Interpersonal Psychotherapy (IPT)
EXPERIMENTALInterpersonal 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)
ACTIVE COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- year-old adolescent girls
- BMI ≥ 75th percentile
- Anxiety symptoms: 32 or higher on State Trait Anxiety Inventory for Children-Trait Scale
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Metis Foundationlead
- Colorado State Universitycollaborator
Study Sites (2)
Colorado State University
Fort Collins, Colorado, 80523-1570, United States
Uniformed Services University
Bethesda, Maryland, 20814, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2021
First Posted
September 8, 2021
Study Start
February 22, 2021
Primary Completion
May 1, 2024
Study Completion
May 1, 2024
Last Updated
September 8, 2021
Record last verified: 2021-08