Weight LossNCT04484831
A Trial to Test an Acceptance-based Therapy Program Among Adolescent Girls With Overweight/Obesity
A study testing ABT Weight Loss Intervention and Enhanced Care in people with Weight Loss and Obesity, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of an acceptance-based therapy weight loss intervention compared with enhanced care for adolescents. Read more about this study
- Who is it for?
- Ages 14 to 19 years, women only
- Conditions the study is for
- Weight Loss, Obesity, Overweight
- What is being tested?
- ABT Weight Loss Intervention and Enhanced Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2020to 22 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent between ages 14-19 with overweight or obesity at or above the 85th percentile for sex and age as determined by CDC growth charts
Who cannot join
- Known pregnancy or plans to become pregnant in the next 2 years
- Plans to move out of the area in the next year
- Autism, any intellectual disability (e.g., down syndrome)
- Any condition prohibiting physical activity
- A diagnosis of cardiovascular disease or diabetes
- Have active cancer or cancer requiring treatment in the past 2 years
Show all 12Show fewer
- Have active or chronic infections (e.g., HIV or TB)
- Have active kidney disease or lung disease
- An eating disorder or substance abuse disorder
- Having recently begun a course of or changed the dosage of any medications known to affect appetite or body composition
- Weight loss greater than or equal to 5% in the previous 6 months
- If they do not follow the study plan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Acceptance-based Therapy Intervention vs. an Enhanced Care Condition for Weight Loss Among Adolescent Girls With Overweight/Obesity: A Randomized, Controlled Trial
The purpose of this study is to investigate the effects of an acceptance-based therapy weight loss intervention compared with enhanced care for adolescents.
Read the detailed description
Participants will complete baseline assessments and adolescents will be randomized to either an ABT weight loss intervention or enhanced care.
The intervention will include 15 sessions over 6 months. Enhanced care will include 15 healthy lifestyle handouts over 6 months.
Post-treatment assessments will occur.
- Conditions
- Weight Loss, Obesity, Overweight
- Being tested
- ABT Weight Loss Intervention, Enhanced Care
- Keywords
- acceptance-based therapy, adolescents, weight, weight loss, obesity, overweight
- Medical subject headings
- Weight Loss, Obesity, Overweight, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT Weight Loss InterventionBehavioural
This includes 15 sessions that are each 90 minutes in length. Intervention sessions will be weekly for the first 2 months, bi-weekly for the next 2 months, and monthly for the last 2 months.
Enhanced CareOther
This includes 15 handouts on elements of a healthy lifestyle and a midpoint one-on-one nutrition consultation with a registered dietitian.
| Study group | Role | What they receive |
|---|---|---|
| ABT Weight Loss Intervention | Experimental | Adolescent participants will attend sessions that include nutritional education and physical activity education and build skills in the areas of values clarification, mindfulness, self-regulation skills, acceptance of uncomfortable states, goal-setting, problem solving, and self-monitoring. Receives: Behavioral: ABT Weight Loss Intervention |
| Enhanced Care | Placebo comparator | Adolescent participants will receive handouts on elements of a healthy lifestyle and will participate in a midpoint one-on-one nutrition consultation with a registered dietitian. Receives: Other: Enhanced Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI Change, 95th BMI Percentile (%)
Changes in weight relative to the BMI at the 95th percentile based on sex-and-age (as a difference in percentage units and/or a difference in BMI units) will be evaluated.
Measured: Baseline; Month 6
Secondary outcomes (3)
Change in Quality of Life
Measurements of quality of life (using the valid Pediatric Quality of Life Inventory assessment: scores 0-100) will be conducted. Higher scores indicate better health-related quality of life.
Measured: Baseline; Month 6
Change in Depression Using the Valid Beck Depression Inventory-II
Depression is measured with the Beck Depression Inventory- II (BDI-II). The BDI-II measures the severity of depression. Each item is assessed on a 4-point ordinal categorical scale (0-3 points) that is specific to the question subject matter being addressed (e.g. sadness, self-criticalness, loss of pleasure, etc), and then answer choices are summed to generate a total score. The BDI-II is reliable and valid in an adolescent population.
Participants receive a sum-score (ranging from 0-63), which correlates with a certain classification and level of depression. Scores 1-10 (normal ups and downs) and 11-16 (mild mood disturbance) are classified as low. Scores 17-20 (borderline clinical depression) and 21-30 (moderate depression) are classified as moderate. Scores 31-40 (severe depression) and 40+ (extreme depression) are classified as significant.
Measured: Baseline; Month 6
Change in Anxiety-sensitivity Using the Valid Short Scale Anxiety Sensitivity Index Assessment
Measurements of anxiety-sensitivity (using the valid Short Scale Anxiety Sensitivity Index-3 assessment: scores 0-20) will be conducted. Higher scores indicate higher anxiety-sensitivity.
Measured: Baseline; Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start21 Jul 2020
- Primary completion7 Jul 2021
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- StayWell, National Heart, Lung, and Blood Institute (NHLBI), WellCare Health Plans, Inc.
- Responsible party
- Sponsor
- Investigators
- Michelle I Cardel, PhD, MS, RD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484831
- Sponsor's protocol ID
- IRB201701609
- Other IDs
- K01HL141535, PA-16-190
- Status last verified
- Sep 2023
- First submitted
- 21 Jul 2020
- Last updated
- 12 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Acceptance-based Therapy Intervention vs. an Enhanced Care Condition for Weight Loss Among Adolescent Girls With Overweight/Obesity: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04484831
- Acronym / sponsor ID
- IRB201701609
- Conditions
- Weight Loss, Obesity, Overweight
- Keywords
- acceptance-based therapy, adolescents, weight, weight loss, obesity, overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- StayWell, National Heart, Lung, and Blood Institute (NHLBI), WellCare Health Plans, Inc.
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Posted 12 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effects of an acceptance-based therapy weight loss intervention compared with enhanced care for adolescents.
Detailed description
Participants will complete baseline assessments and adolescents will be randomized to either an ABT weight loss intervention or enhanced care.
The intervention will include 15 sessions over 6 months. Enhanced care will include 15 healthy lifestyle handouts over 6 months.
Post-treatment assessments will occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABT Weight Loss Intervention | Experimental | Behavioral: ABT Weight Loss InterventionAdolescent participants will attend sessions that include nutritional education and physical activity education and build skills in the areas of values clarification, mindfulness, self-regulation skills, acceptance of uncomfortable states, goal-setting, problem solving, and self-monitoring. |
| Enhanced Care | Placebo comparator | Other: Enhanced CareAdolescent participants will receive handouts on elements of a healthy lifestyle and will participate in a midpoint one-on-one nutrition consultation with a registered dietitian. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescent between ages 14-19 with overweight or obesity at or above the 85th percentile for sex and age as determined by CDC growth charts
Key exclusion criteria (12 listed)
- Known pregnancy or plans to become pregnant in the next 2 years
- Plans to move out of the area in the next year
- Autism, any intellectual disability (e.g., down syndrome)
- Any condition prohibiting physical activity
- A diagnosis of cardiovascular disease or diabetes
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 |
|---|---|---|
| ABT Weight Loss InterventionThis includes 15 sessions that are each 90 minutes in length. Intervention sessions will be weekly for the first 2 months, bi-weekly for the next 2 months, and monthly for the last 2 months. | Behavioural | ABT Weight Loss Intervention |
| Enhanced CareThis includes 15 handouts on elements of a healthy lifestyle and a midpoint one-on-one nutrition consultation with a registered dietitian. | Other | Enhanced Care |
Primary outcome
BMI Change, 95th BMI Percentile (%)
Time frame: Baseline; Month 6
Changes in weight relative to the BMI at the 95th percentile based on sex-and-age (as a difference in percentage units and/or a difference in BMI units) will be evaluated.
3 secondary outcomes
Change in Quality of Life
Time frame: Baseline; Month 6
Change in Depression Using the Valid Beck Depression Inventory-II
Time frame: Baseline; Month 6
Change in Anxiety-sensitivity Using the Valid Short Scale Anxiety Sensitivity Index Assessment
Time frame: Baseline; Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Michelle I Cardel, PhD, MS, RD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABT Weight Loss Intervention and Enhanced Care in people with Weight Loss and Obesity, run by University of Florida at 1 site 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 1 inclusion and 12 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 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 12 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
BMI Change, 95th BMI Percentile (%) (time frame: Baseline; Month 6). 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 12 Oct 2023.