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

Primary Purpose

Obesity, Overweight, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interpersonal Psychotherapy (IPT)
Cognitive Behavioral Theory (CBT)
Sponsored by
The Metis Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Obesity, Overweight, Anxiety, Adolescent, Prevention, Interpersonal Psychotherapy, Cognitive Behavioral Therapy

Eligibility Criteria

12 Years - 17 Years (Child)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Colorado State UniversityRecruiting
  • Uniformed Services UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interpersonal Psychotherapy (IPT)

Cognitive-Behavioral Therapy (CBT)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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).
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.
Body Composition Measurement
Assessed using air displacement plethysmography (Bod Pod).
Collection of Metabolic Markers
Blood will be drawn in a fasted state to measure glucose, insulin, and lipids.
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).
Cardiometabolic Functioning
Measured by blood draw, continuous glucose monitoring, and heart rate, sleep and activity via Carnation Ambulatory Monitor.
Movement and Activity
Measured by ActivPal monitoring device

Full Information

First Posted
August 31, 2021
Last Updated
August 31, 2021
Sponsor
The Metis Foundation
Collaborators
Colorado State University
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1. Study Identification

Unique Protocol Identification Number
NCT05038033
Brief Title
Addressing Anxiety and Stress for Healthier Eating in Teens
Acronym
ASSET
Official Title
Addressing Anxiety and Stress for Healthier Eating in Teens
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Metis Foundation
Collaborators
Colorado State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Anxiety, Mental Disorders, Body Weight, Eating Behavior, Feeding and Eating Disorders
Keywords
Obesity, Overweight, Anxiety, Adolescent, Prevention, Interpersonal Psychotherapy, Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with two treatment arms and two intervention cohorts across two sites.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Rice, PhD
Phone
310-845-5058
Email
alexander.rice.ctr@usuhs.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Natalia Sanchez, MPH
Phone
970-491-1120
Email
Natalia.Sanchez@colostate.edu
Facility Information:
Facility Name
Colorado State University
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80523-1570
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalia Sanchez
Phone
970-491-1120
Email
Natalia.Sanchez@colostate.edu
First Name & Middle Initial & Last Name & Degree
Lauren Shomaker, PhD
Facility Name
Uniformed Services University
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Rice, PhD
Phone
310-845-5058
Email
alexander.rice.ctr@usuhs.edu
First Name & Middle Initial & Last Name & Degree
Julia Gallagher-Teske, BS
Phone
301-400-4401
Email
julia.gallagher-teske.ctr@usuhs.edu
First Name & Middle Initial & Last Name & Degree
Mairan Tanofsky-Kraff, PhD

12. IPD Sharing Statement

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Addressing Anxiety and Stress for Healthier Eating in Teens

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