ObesityASSETNCT05038033
Addressing Anxiety and Stress for Healthier Eating in Teens
A study testing Interpersonal Psychotherapy (IPT) and Cognitive Behavioral Theory (CBT) in people with Obesity and Overweight, run by The Metis Foundation at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Anxiety
- What is being tested?
- Interpersonal Psychotherapy (IPT) and Cognitive Behavioral Theory (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Feb 2021to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- Women only
- Healthy volunteers accepted
- Child
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Uniformed Services University
Bethesda, Maryland, 20814
Alexander Rice, PhD, 310-845-5058, alexander.rice.ctr@usuhs.edu
Julia Gallagher-Teske, BS, 301-400-4401, julia.gallagher-teske.ctr@usuhs.edu
- Recruiting
Colorado State University
Fort Collins, Colorado, 80523-1570
Natalia Sanchez, 970-491-1120, Natalia.Sanchez@colostate.edu
Lauren Shomaker, PhD
About this study
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.
Read the 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.
- Conditions
- Obesity, Overweight, Anxiety, Mental Disorders, Body Weight, Eating Behavior
- Being tested
- Interpersonal Psychotherapy (IPT), Cognitive Behavioral Theory (CBT)
- Keywords
- Obesity, Overweight, Anxiety, Adolescent, Prevention, Interpersonal Psychotherapy, Cognitive Behavioral Therapy
- Medical subject headings
- Obesity, Overweight, Anxiety Disorders, Mental Disorders, Body Weight, Feeding Behavior, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal Psychotherapy (IPT)Behavioural
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.
Cognitive Behavioral Theory (CBT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Interpersonal Psychotherapy (IPT) | Experimental | 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. Receives: Behavioral: Interpersonal Psychotherapy (IPT) |
| Cognitive-Behavioral Therapy (CBT) | Active comparator | 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. Receives: Behavioral: Cognitive Behavioral Theory (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Entirety of the Study
Secondary outcomes (8)
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.
Measured: 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).
Measured: 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.
Measured: Post Treatment
Body Composition Measurement
Assessed using air displacement plethysmography (Bod Pod).
Measured: Post treatment
Collection of Metabolic Markers
Blood will be drawn in a fasted state to measure glucose, insulin, and lipids.
Measured: 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).
Measured: Post Treatment
Cardiometabolic Functioning
Measured by blood draw, continuous glucose monitoring, and heart rate, sleep and activity via Carnation Ambulatory Monitor.
Measured: Post Treatment
Movement and Activity
Measured by ActivPal monitoring device
Measured: Post Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start22 Feb 2021
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with two treatment arms and two intervention cohorts across two sites.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Metis Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado State University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038033
- Sponsor's protocol ID
- USUHS.2020-048
- Acronym
- ASSET
- Status last verified
- Aug 2021
- First submitted
- 31 Aug 2021
- Last updated
- 8 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Anxiety and Stress for Healthier Eating in Teens
- ClinicalTrials.gov ID
- NCT05038033
- Acronym / sponsor ID
- ASSET / USUHS.2020-048
- Conditions
- Obesity, Overweight, Anxiety, Mental Disorders, Body Weight, Eating Behavior
- Keywords
- Obesity, Overweight, Anxiety, Adolescent, Prevention, Interpersonal Psychotherapy, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Metis FoundationUniversity, hospital or other
- Collaborators
- Colorado State University
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial with two treatment arms and two intervention cohorts across two sites.
| Arm | Type | Receives |
|---|---|---|
| Interpersonal Psychotherapy (IPT) | Experimental | Behavioral: 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) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Interpersonal Psychotherapy (IPT) |
| 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. | Behavioural | Cognitive-Behavioral Therapy (CBT) |
Primary outcome
Intervention Fidelity and Acceptability
Time frame: 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
8 secondary outcomes
Presence of Disinhibited Eating
Time frame: Post-Treatment
Mood/Anxiety, Eating, And Social Functioning
Time frame: Post Treatment
Participant Height, Weight, and Blood Pressure
Time frame: Post Treatment
Body Composition Measurement
Time frame: Post treatment
Collection of Metabolic Markers
Time frame: Post Treatment
Parental report of eating behaviors
Time frame: Post Treatment
Cardiometabolic Functioning
Time frame: Post Treatment
Movement and Activity
Time frame: Post Treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal Psychotherapy (IPT) and Cognitive Behavioral Theory (CBT) in people with Obesity and Overweight, run by The Metis Foundation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Rice, PhD (310-845-5058, alexander.rice.ctr@usuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Fidelity and Acceptability (time frame: Entirety of the Study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.