Overweight and ObesityFRESH-TEENNCT03674944
FRESH-TEEN: Families Responsibility Education Support Health for Teens
A study testing Behavioral Weight Loss (BWL) + Emotion Regulation (ER) and Behavioral Weight Loss (BWL) in people with Overweight and Obesity, run by University of California, San Diego at 2 sites in United States.
Trial summary
The objective of this proposed study is to collect initial efficacy data on a behavioral weight loss (BWL) program for teens, which also includes emotion regulation strategies (ER), to standard BWL. Read more about this study
- Who is it for?
- Ages 13 to 16 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Behavioral Weight Loss (BWL) + Emotion Regulation (ER) and Behavioral Weight Loss (BWL)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Sep 2019to 4 Jan 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 13 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adolescent age 13-16 years
- BMI percentile 85%85%-99.9% (adolescent only)
- Ability to read English at a minimum 6th grade level (both adolescent and parent); and willing to participate in a 6-month treatment and all assessments (both adolescent and parent)
Who cannot join
- Current enrollment in a weight management program (Child and Parent);
- Medication that is specifically prescribed for weight loss (Child and Parent);
- Medical or psychiatric condition that may interfere with treatment participation (Child and Parent);
- Regular use of compensatory behavior for weight loss (e.g., purging) during the past six months (Child and Parent);
- Current pregnancy or lactating (Child and Parent);
- Change in psychotropic medication during the previous three months (Child and Parent).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCSD Center for Healthy Eating and Activity Research (CHEAR)
La Jolla, California, 92037
Ambulatory Research Center - University of Minnesota
Minneapolis, Minnesota, 55454
About this study
Official title: Targeting Emotional Eating and Weight Loss in Adolescents
The objective of this proposed study is to collect initial efficacy data on a behavioral weight loss (BWL) program for teens, which also includes emotion regulation strategies (ER), to standard BWL.
Read the detailed description
The study will compare the efficacy of BWL + ER and BWL. Investigators will provide 6 months of treatment (BWL + ER or BWL) and will follow participants at 12-months post-treatment (total time = 18 months). Investigators will recruit adolescents with overweight and obesity and their parents. Dyads will be assessed at 5 timepoints: baseline (2 visits), mid-treatment (1 visit), post-treatment (2 visits), 6-month follow-up (2 visits), and 12-month follow-up (2 visits). Assessments will include the following for the adolescent and parent: anthropometry, emotion regulation, emotional inhibition, emotional eating, and adolescent-parent relationship measures. This program of research has the potential to advance the standard of practice for adolescents who are overweight or obese by providing alternative interventions.
We are currently offering online treatment groups to accommodate the CDC health and safety guidelines.
- Conditions
- Overweight and Obesity
- Being tested
- Behavioral Weight Loss (BWL) + Emotion Regulation (ER), Behavioral Weight Loss (BWL)
- Keywords
- Overweight, Obesity, Overeating, Treatment, Body Mass Index, Intervention, Behavioral Treatment, Dialectical Behavior Therapy, Emotion Regulation
- Medical subject headings
- Overweight, Obesity, Hyperphagia, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Weight Loss (BWL) + Emotion Regulation (ER)Behavioural
The BWL + ER program will teach Dialectical Behavior Therapy (DBT) skills (dialectical abstinence, emotion regulation skills, mindfulness, and distress tolerance) to the adolescent and parent group sessions. Parents are expected to model skill usage and DBT language with their teen to reinforce the skills at home. Adolescents and parents will track emotions and DBT skills used in diary cards which will be provided. Emotion-Focused Parent Training (EFPT) will be provided to the parents at each session to train the parent to support the adolescent in processing emotions, increasing parental emotion self-efficacy, promoting positive parent-adolescent relationships, and reducing the need for dysfunctional emotion regulation behaviors.Behavior coaching will be provided to the adolescent and parent to encourage compliance and review skills after each session (DBT or BWL).
Behavioral Weight Loss (BWL)Behavioural
Also called BWL
All participants will be instructed to consume an energy restricted diet based on initial body weight. Participants will be instructed to record and self-monitor their food intake. The physical activity component will focus on increasing both lifestyle activity and structured exercise programs. Behavior change recommendations will include: self-monitoring, goal setting, managing high-risk situations, and relapse prevention. Parenting skills will be discussed during parent group sessions which will encourage parents to adopt authoritative parenting styles with regard to eating and exercise behaviors. Parents will also learn about behavioral modification principles, including modeling, reinforcement, and operant conditioning. Behavior coaching will be provided to the adolescent and parent after each session to encourage compliance, discuss completed homework, review habit books to praise efforts and give feedback for areas of improvement.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Weight Loss (BWL) + Emotion Regulation (ER) | Experimental | This program includes: 1) Dialectical Behavior Therapy (DBT) skills 2) Behavioral coaching 3) Emotional Focused Parent Training (EFPT) 4) Behavioral Weight Loss (BWL) skills. Receives: Behavioral: Behavioral Weight Loss (BWL) + Emotion Regulation (ER); Behavioral: Behavioral Weight Loss (BWL) |
| Behavioral Weight Loss (BWL) | Active comparator | This program includes information about diet and physical activity education, in addition to parent management skills, and behavioral modification principles including: modeling, reinforcement, and operant conditioning. Receives: Behavioral: Behavioral Weight Loss (BWL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescent weight loss as measured by BMI, BMIz
Measured: Change from baseline to month 3, 6, 12, and 18.
Emotion Regulation Skills as measured by Ecological Momentary Assessment using State Difficulties in Emotion Regulation and International Positive and Negative Affect Schedule- Short form
Measured: Change from baseline to month 3, 6, 12, and 18.
Emotional Eating as measured by Emotional Eating Scale for children (EES-C)
Measured: Change from baseline to month 3, 6, 12, and 18.
Secondary outcomes (4)
Parent BMI as measured by height and weight
Measured: Change from baseline to month 3, 6, 12, and 18.
Parent emotion regulation measured by Difficulties in Emotion Regulation Scale (DERS)
Measured: Change from baseline to month 3, 6, 12, and 18.
Parent emotional eating as measured by Emotional Eating Scale (EES)
Measured: Change from baseline to month 3, 6, 12, and 18.
Parent-adolescent relationship as measured by using: Inventory of Parents and Peer Attachment and Parental bonding assessment
Measured: Change from baseline to month 3, 6, 12, and 18.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start16 Sep 2019
- Primary completion12 Dec 2023
- Study completion4 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Kerri Boutelle, University of California, San Diego
- Investigators
- Kerri Boutelle, Ph.D., Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674944
- Sponsor's protocol ID
- 180417
- Other IDs
- R01DK116616
- Acronym
- FRESH-TEEN
- Status last verified
- Apr 2024
- First submitted
- 22 Aug 2018
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boutelle KN, Manzano MA, Pasquale EK, Strong DR, Bernard RS, Rhee KE, Eichen DM, Miller A, Peterson CB. Emotion-Focused Behavioral Weight Loss Treatment for Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2639867. doi: 10.1001/jamanetworkopen.2026.39867.
PubMed 42911592Boutelle KN, Manzano MA, Pasquale EK, Bernard RS, Strong DR, Rhee KE, Eichen DM, Engel S, Miller A, Peterson CB. Design of the FRESH-teen study: A randomized controlled trial evaluating an adapted emotion regulation weight loss program for adolescents with overweight or obesity and their parent. Contemp Clin Trials. 2024 Oct;145:107640. doi: 10.1016/j.cct.2024.107640. Epub 2024 Jul 28.
PubMed 39079614
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Emotional Eating and Weight Loss in Adolescents
- ClinicalTrials.gov ID
- NCT03674944
- Acronym / sponsor ID
- FRESH-TEEN / 180417
- Conditions
- Overweight and Obesity
- Keywords
- Overweight, Obesity, Overeating, Treatment, Body Mass Index, Intervention, Behavioral Treatment, Dialectical Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- University of Minnesota, National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 18 Sep 2018 (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.
The objective of this proposed study is to collect initial efficacy data on a behavioral weight loss (BWL) program for teens, which also includes emotion regulation strategies (ER), to standard BWL.
Detailed description
The study will compare the efficacy of BWL + ER and BWL. Investigators will provide 6 months of treatment (BWL + ER or BWL) and will follow participants at 12-months post-treatment (total time = 18 months). Investigators will recruit adolescents with overweight and obesity and their parents. Dyads will be assessed at 5 timepoints: baseline (2 visits), mid-treatment (1 visit), post-treatment (2 visits), 6-month follow-up (2 visits), and 12-month follow-up (2 visits). Assessments will include the following for the adolescent and parent: anthropometry, emotion regulation, emotional inhibition, emotional eating, and adolescent-parent relationship measures. This program of research has the potential to advance the standard of practice for adolescents who are overweight or obese by providing alternative interventions.
We are currently offering online treatment groups to accommodate the CDC health and safety guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Weight Loss (BWL) + Emotion Regulation (ER) | Experimental | Behavioral: Behavioral Weight Loss (BWL) + Emotion Regulation (ER), Behavioral: Behavioral Weight Loss (BWL)This program includes: 1) Dialectical Behavior Therapy (DBT) skills 2) Behavioral coaching 3) Emotional Focused Parent Training (EFPT) 4) Behavioral Weight Loss (BWL) skills. |
| Behavioral Weight Loss (BWL) | Active comparator | Behavioral: Behavioral Weight Loss (BWL)This program includes information about diet and physical activity education, in addition to parent management skills, and behavioral modification principles including: modeling, reinforcement, and operant conditioning. |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Adolescent age 13-16 years
- BMI percentile 85%85%-99.9% (adolescent only)
- Ability to read English at a minimum 6th grade level (both adolescent and parent); and willing to participate in a 6-month treatment and all assessments (both adolescent and parent)
Key exclusion criteria (6 listed)
- Current enrollment in a weight management program (Child and Parent);
- Medication that is specifically prescribed for weight loss (Child and Parent);
- Medical or psychiatric condition that may interfere with treatment participation (Child and Parent);
- Regular use of compensatory behavior for weight loss (e.g., purging) during the past six months (Child and Parent);
- Current pregnancy or lactating (Child and Parent);
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 |
|---|---|---|
| Behavioral Weight Loss (BWL) + Emotion Regulation (ER)The BWL + ER program will teach Dialectical Behavior Therapy (DBT) skills (dialectical abstinence, emotion regulation skills, mindfulness, and distress tolerance) to the adolescent and parent group sessions. Parents are expected to model skill usage and DBT language with their teen to reinforce the skills at home. Adolescents and parents will track emotions and DBT skills used in diary cards which will be provided. Emotion-Focused Parent Training (EFPT) will be provided to the parents at each session to train the parent to support the adolescent in processing emotions, increasing parental emotion self-efficacy, promoting positive parent-adolescent relationships, and reducing the need for dysfunctional emotion regulation behaviors.Behavior coaching will be provided to the adolescent and parent to encourage compliance and review skills after each session (DBT or BWL). | Behavioural | Behavioral Weight Loss (BWL) + Emotion Regulation (ER) |
| Behavioral Weight Loss (BWL)Also: BWLAll participants will be instructed to consume an energy restricted diet based on initial body weight. Participants will be instructed to record and self-monitor their food intake. The physical activity component will focus on increasing both lifestyle activity and structured exercise programs. Behavior change recommendations will include: self-monitoring, goal setting, managing high-risk situations, and relapse prevention. Parenting skills will be discussed during parent group sessions which will encourage parents to adopt authoritative parenting styles with regard to eating and exercise behaviors. Parents will also learn about behavioral modification principles, including modeling, reinforcement, and operant conditioning. Behavior coaching will be provided to the adolescent and parent after each session to encourage compliance, discuss completed homework, review habit books to praise efforts and give feedback for areas of improvement. | Behavioural | Behavioral Weight Loss (BWL), Behavioral Weight Loss (BWL) + Emotion Regulation (ER) |
Primary outcome
Adolescent weight loss as measured by BMI, BMIz
Time frame: Change from baseline to month 3, 6, 12, and 18.
Emotion Regulation Skills as measured by Ecological Momentary Assessment using State Difficulties in Emotion Regulation and International Positive and Negative Affect Schedule- Short form
Time frame: Change from baseline to month 3, 6, 12, and 18.
Emotional Eating as measured by Emotional Eating Scale for children (EES-C)
Time frame: Change from baseline to month 3, 6, 12, and 18.
4 secondary outcomes
Parent BMI as measured by height and weight
Time frame: Change from baseline to month 3, 6, 12, and 18.
Parent emotion regulation measured by Difficulties in Emotion Regulation Scale (DERS)
Time frame: Change from baseline to month 3, 6, 12, and 18.
Parent emotional eating as measured by Emotional Eating Scale (EES)
Time frame: Change from baseline to month 3, 6, 12, and 18.
Parent-adolescent relationship as measured by using: Inventory of Parents and Peer Attachment and Parental bonding assessment
Time frame: Change from baseline to month 3, 6, 12, and 18.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Derived from this study: PubMed 42911592Boutelle KN, Manzano MA, Pasquale EK, Strong DR, Bernard RS, Rhee KE, Eichen DM, Miller A, Peterson CB. Emotion-Focused Behavioral Weight Loss Treatment for Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2639867. doi: 10.1001/jamanetworkopen.2026.39867.
- Derived from this study: PubMed 39079614Boutelle KN, Manzano MA, Pasquale EK, Bernard RS, Strong DR, Rhee KE, Eichen DM, Engel S, Miller A, Peterson CB. Design of the FRESH-teen study: A randomized controlled trial evaluating an adapted emotion regulation weight loss program for adolescents with overweight or obesity and their parent. Contemp Clin Trials. 2024 Oct;145:107640. doi: 10.1016/j.cct.2024.107640. Epub 2024 Jul 28.
- Individual participant dataSharing planned: No
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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.
Kerri Boutelle, Ph.D. principal investigator
UCSD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Weight Loss (BWL) + Emotion Regulation (ER) and Behavioral Weight Loss (BWL) in people with Overweight and Obesity, run by University of California, San Diego 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?
The sponsor lists 3 inclusion and 6 exclusion criteria. 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: finished, as of the sponsor's last update on 24 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adolescent weight loss as measured by BMI, BMIz (time frame: Change from baseline to month 3, 6, 12, and 18.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03674944, which also lists 2 linked publications.
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 24 Sep 2024.