Body WeightSWIFTNCT06389656
Addressing Weight Bias Internalization to Improve Adolescent Weight Management Outcomes: Open Trial
A study testing Behavioral Weight Management and Weight Bias Internalization in people with Body Weight and Weight Bias, run by The Miriam Hospital at 1 site in United States.
Trial summary
Weight stigma and weight bias internalization (WBI) are common among adolescents at higher weight statuses. WBI is associated with negative physical and mental health outcomes. The current study aims to test intervention for weight stigma and WBI in conjunction with an evidence-based adolescent weight management… Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight, Weight Bias, Weight Stigma
- What is being tested?
- Behavioral Weight Management and Weight Bias Internalization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2024to 18 Apr 2025
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- speak English
- 13-17 years of age
- BMI at or above >95th%ile for age and sex
- have at least one caregiver available to provide consent and participate in sessions
- agree to study participation
Who cannot join
- Cognitive impairment or developmental delay impairing participation in a group setting
- Current participation in a weight management program or recent weight loss of 5% of body weight or more
- Medical condition known to impact weight or that would otherwise prevent participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Piloting an Intervention to Address Weight Bias Internalization to Improve Adolescent Weight Management Outcomes
Weight stigma and weight bias internalization (WBI) are common among adolescents at higher weight statuses. WBI is associated with negative physical and mental health outcomes. The current study aims to test intervention for weight stigma and WBI in conjunction with an evidence-based adolescent weight management program. Adolescents (ages 13-17) will participate in a 20-week program tailored to improve WBI and weight-related health behaviors in tandem. Primary outcomes are feasibility and acceptability of the developed intervention, assessed following the 20-week intervention.
Read the detailed description
The overall goal of this project is to examine the impact of intervening on weight bias internalization (WBI) in conjunction with evidence-based adolescent behavioral weight management (BWM) and to assess reduction in key mechanisms of stress resulting from weight stigma (i.e., biological markers of stress and inflammation, dysregulated eating behaviors) and subsequent impact on weight loss interference resulting from WBI. An open trial with 16 adolescents (2 cohorts; 8/group) will be conducted to test initial acceptability and feasibility of the 20-week WBI+BWM intervention in an open trial. Quantitative and qualitative feedback concerning acceptability and feasibility will be solicited to refine the intervention. Participants are adolescents (ages 13-17 years old) at higher weight status (BMI percentile at or equal to the 95th percentile) will participate in a 20-session weekly intervention focused on weight bias internalization and healthy weight management strategies.
- Conditions
- Body Weight, Weight Bias, Weight Stigma, Weight
- Being tested
- Behavioral Weight Management, Weight Bias Internalization
- Medical subject headings
- Body Weight, Weight Prejudice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Weight ManagementBehavioural
Prescription of diet and physical activity strategies, paired with behavioral strategies for weight management.
Weight Bias InternalizationBehavioural
Addressing weight stigma and improving weight-related self-perception, through challenging weight-related stereotypes, self-compassion, reducing self-criticism, and coping with weight stigma.
| Study group | Role | What they receive |
|---|---|---|
| WBI+BWM | Experimental | WBI+BWM will be a multicomponent behavioral weight loss intervention designed to address both weight bias internalization and weight status in adolescents. The first four sessions of the intervention will be focused on targeted WBI/weight stigma content, followed by 16 sessions addressing both weight stigma/WBI and evidence-based weight management strategies. Weekly meetings are scheduled for 75 minutes and are facilitated by a behavioral expert (e.g., PhD in clinical psychology). Caregivers attend 4 of the 20 weekly groups with their teens. Receives: Behavioral: Behavioral Weight Management; Behavioral: Weight Bias Internalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Score on an Adapted Version of the Acceptability of Intervention Measure (AIM)
Intervention acceptability refers to the extent to which the WBI+BWC intervention is agreeable, palatable, or satisfactory to adolescents engaging in the treatment. We adapted the validated Acceptability of Intervention Measure (AIM) to assess adolescent acceptance related to treatment components following each intervention session. Total scores range from 1-5, with higher scores indicative of higher levels of intervention acceptability.
Measured: Post-Treatment (5 months)
Attendance Rates at Intervention Sessions
Feasibility includes the extent to which adolescents are able to utilize the intervention components offered. Attendance at group sessions will be used to measure feasibility, with the minimal benchmark set at 75%. Average number of sessions attended is reported.
Measured: Post-Treatment (5 months)
Retention Rate for Intervention Sessions
Feasibility includes the extent to which adolescents are able to utilize the intervention components offered. Retention, as measured by the drop-out rate for the intervention program, will be used to measure feasibility, with the minimal benchmark set at 80%.
Measured: Post-Treatment (5 months)
Secondary outcomes (4)
Total Score on the Modified Weight Bias Internalization Scale (WBIS-M)
The validated Modified Weight Bias Internalization Scale (WBIS-M) assesses the degree to which people apply negative weight-based stereotypes to themselves and judge themselves negatively due to their weight. Respondents rate eleven items on a 7-point Likert scale and the average, accounting for reverse-scored items, is used as a measure of WBI. Higher scores indicate a greater degree of WBI (range: 1-7).
Measured: Change from Baseline to Post-Treatment (5 months)
Total Score on the Weight Self-Stigma Questionnaire (WSSQ)
The Weight Self-Stigma Questionnaire (WSSQ) measures weight-related self-devaluation and fear of enacted stigma. Respondents rate 12 items on a 5-point Likert scale, resulting in total scores between 12-60. Higher scores indicate a greater degree of internalized stigma.
Measured: Change from Baseline to Post-Treatment (5 months)
Total Score on the Weight-related Teasing Sub-scale of the Perception of Teasing Scale (POTS)
The validated Perception of Teasing Scale (POTS) will be used to measure adolescents' experiences of weight based stigma separate from WBI. The scale has two sub-scales: a weight-related teasing sub-scale and a competency-related teasing subscale. On the 6 item weight-related teasing sub-scale, participants rate frequency of teasing on a 5-point Likert scale, and how upset they were by it on a separate 5-point scale. Responses are totaled across the two Likert scales, resulting in scores between the range of 6-30. Higher scores indicate a higher frequency of historical weight-based teasing.
Measured: Change from Baseline to Post-Treatment (5 months)
Anthropometrics
Height will be measured in triplicate using a stationary stadiometer to the nearest 0.1 cm. Body weight will be measured in triplicate using a calibrated digital scale to the nearest 0.1 kg. The average height and weight measurements will be used to calculate body mass index (BMI) and percent of the 95th percentile of BMI for age and sex.
Measured: Change from Baseline to Post-Treatment (5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start8 Apr 2024
- Primary completion18 Apr 2025
- Study completion18 Apr 2025
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 Body WeightStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open trial
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Darling, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389656
- Sponsor's protocol ID
- 1K23DK135791-01
- Acronym
- SWIFT
- Status last verified
- Dec 2025
- First submitted
- 17 Apr 2024
- Last updated
- 15 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting an Intervention to Address Weight Bias Internalization to Improve Adolescent Weight Management Outcomes
- ClinicalTrials.gov ID
- NCT06389656
- Acronym / sponsor ID
- SWIFT / 1K23DK135791-01
- Conditions
- Body Weight, Weight Bias, Weight Stigma, Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 29 Apr 2024 (actual)
- Results
- Posted 15 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Weight stigma and weight bias internalization (WBI) are common among adolescents at higher weight statuses. WBI is associated with negative physical and mental health outcomes. The current study aims to test intervention for weight stigma and WBI in conjunction with an evidence-based adolescent weight management program. Adolescents (ages 13-17) will participate in a 20-week program tailored to improve WBI and weight-related health behaviors in tandem. Primary outcomes are feasibility and acceptability of the developed intervention, assessed following the 20-week intervention.
Detailed description
The overall goal of this project is to examine the impact of intervening on weight bias internalization (WBI) in conjunction with evidence-based adolescent behavioral weight management (BWM) and to assess reduction in key mechanisms of stress resulting from weight stigma (i.e., biological markers of stress and inflammation, dysregulated eating behaviors) and subsequent impact on weight loss interference resulting from WBI. An open trial with 16 adolescents (2 cohorts; 8/group) will be conducted to test initial acceptability and feasibility of the 20-week WBI+BWM intervention in an open trial. Quantitative and qualitative feedback concerning acceptability and feasibility will be solicited to refine the intervention. Participants are adolescents (ages 13-17 years old) at higher weight status (BMI percentile at or equal to the 95th percentile) will participate in a 20-session weekly intervention focused on weight bias internalization and healthy weight management strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open trial
| Arm | Type | Receives |
|---|---|---|
| WBI+BWM | Experimental | Behavioral: Behavioral Weight Management, Behavioral: Weight Bias InternalizationWBI+BWM will be a multicomponent behavioral weight loss intervention designed to address both weight bias internalization and weight status in adolescents. The first four sessions of the intervention will be focused on targeted WBI/weight stigma content, followed by 16 sessions addressing both weight stigma/WBI and evidence-based weight management strategies. Weekly meetings are scheduled for 75 minutes and are facilitated by a behavioral expert (e.g., PhD in clinical psychology). Caregivers attend 4 of the 20 weekly groups with their teens. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- speak English
- 13-17 years of age
- BMI at or above >95th%ile for age and sex
- have at least one caregiver available to provide consent and participate in sessions
- agree to study participation
Key exclusion criteria (3 listed)
- Cognitive impairment or developmental delay impairing participation in a group setting
- Current participation in a weight management program or recent weight loss of 5% of body weight or more
- Medical condition known to impact weight or that would otherwise prevent participation
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 ManagementPrescription of diet and physical activity strategies, paired with behavioral strategies for weight management. | Behavioural | WBI+BWM |
| Weight Bias InternalizationAddressing weight stigma and improving weight-related self-perception, through challenging weight-related stereotypes, self-compassion, reducing self-criticism, and coping with weight stigma. | Behavioural | WBI+BWM |
Primary outcome
Total Score on an Adapted Version of the Acceptability of Intervention Measure (AIM)
Time frame: Post-Treatment (5 months)
Intervention acceptability refers to the extent to which the WBI+BWC intervention is agreeable, palatable, or satisfactory to adolescents engaging in the treatment. We adapted the validated Acceptability of Intervention Measure (AIM) to assess adolescent acceptance related to treatment components following each intervention session. Total scores range from 1-5, with higher scores indicative of higher levels of intervention acceptability.
Attendance Rates at Intervention Sessions
Time frame: Post-Treatment (5 months)
Feasibility includes the extent to which adolescents are able to utilize the intervention components offered. Attendance at group sessions will be used to measure feasibility, with the minimal benchmark set at 75%. Average number of sessions attended is reported.
Retention Rate for Intervention Sessions
Time frame: Post-Treatment (5 months)
Feasibility includes the extent to which adolescents are able to utilize the intervention components offered. Retention, as measured by the drop-out rate for the intervention program, will be used to measure feasibility, with the minimal benchmark set at 80%.
4 secondary outcomes
Total Score on the Modified Weight Bias Internalization Scale (WBIS-M)
Time frame: Change from Baseline to Post-Treatment (5 months)
Total Score on the Weight Self-Stigma Questionnaire (WSSQ)
Time frame: Change from Baseline to Post-Treatment (5 months)
Total Score on the Weight-related Teasing Sub-scale of the Perception of Teasing Scale (POTS)
Time frame: Change from Baseline to Post-Treatment (5 months)
Anthropometrics
Time frame: Change from Baseline to Post-Treatment (5 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Katherine Darling, PhD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Weight Management and Weight Bias Internalization in people with Body Weight and Weight Bias, run by The Miriam Hospital 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 5 inclusion and 3 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 15 Oct 2026. 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. 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 15 Oct 2026). 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?
Total Score on an Adapted Version of the Acceptability of Intervention Measure (AIM) (time frame: Post-Treatment (5 months)). 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?
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 15 Oct 2026.