WeightSWIFTNCT06864208
Addressing Weight Bias Internalization to Improve Adolescent Weight Management Outcomes: Randomized Pilot Trial
A study testing Behavioral Weight Management and Weight Bias Internalization in people with Weight and Body Weight, 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 an intervention for weight stigma and WBI combined with an evidence-based adolescent weight management program. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Weight, Body Weight, Weight Bias
- 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
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- 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;
- Current use of glucagon-like peptide-1 (GLP-1) receptor agonists;
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 an intervention for weight stigma and WBI combined with an evidence-based adolescent weight management program. Eligible adolescents (13-17) will be assigned by chance to one of two groups: 1) a 4-week intervention focused on weight stigma and WBI followed by a 16-week behavioral weight management program; or 2) a 4-week health information control (to include non-weight-related health promotion topics such as smoking and skin cancer prevention) followed by the same 16-week weight management program but without the WBI and weight stigma content. Study outcomes will be assessed at the 4-week and post-treatment (20 week) timepoints.
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 was previously conducted to test initial acceptability and feasibility of a newly developed 20-week WBI+BWM intervention (ClinicalTrials.gov ID: NCT06389656). The intervention consisted of 4 weeks of WBI followed by a 16-week BWM intervention with integrated WBI and weight stigma content. Quantitative and qualitative feedback concerning acceptability and feasibility were solicited to refine the intervention. The current study is a randomized trial that will compare the 20-week WBI+BWM intervention developed in the open trial to a Health Information Control (HIC) + BWM condition. The HIC+BWM intervention consists of a 4-week health information control (consisting of non-weight-related health promotion topics such as smoking and skin cancer) followed by the same 16-week BMI, but without WBI and weight stigma content.
Primary and secondary outcomes will be assessed at the 4- and 20-week (post-treatment) timepoints. This study will evaluate the impact of the interventions on WBI, biological markers of stress and inflammation (cortisol, CRP, IL-6), and dysregulated eating behaviors. Changes in weight status will also be examined. Feasibility and acceptability will be measured during the pilot RCT to ensure ongoing fit of the intervention to the adolescent population. Data will provide effect size estimates of the impact on adolescent BMI for a large-scale randomized controlled trial (RCT).
- Conditions
- Weight, Body Weight, Weight Bias, Weight Stigma, Physiological Stress, Biological Markers of Stress
- Being tested
- Behavioral Weight Management, Weight Bias Internalization
- Keywords
- Adolescents, Teens, Weight, C-reactive protein, CRP, Interleukin-6, IL-6, Eating behaviors, Behavioral weight management, Weight bias, Weight stigma
- Medical subject headings
- Body Weight, Weight Prejudice, Feeding Behavior
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, practicing self-compassion, reducing self-criticism, and coping with weight stigma
| Study group | Role | What they receive |
|---|---|---|
| Weight Bias Internalization + Behavioral Weight Management Intervention (WBI + BWM) | Experimental | WBI+BWM is 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 |
| Health Information Control + Behavioral Weight Management Intervention (HIC + BWM) | Active comparator | The first four sessions (weeks 1-4) of the HIC+BWM group will focus on health promotion for adolescent health concerns other than weight management (e.g., skin cancer prevention, smoking cessation). This health information control will allow for testing of the initial 4- week WBI intervention as compared to a contact-matched control. Following the four-week health education control, the remaining 16 sessions will focus on evidence-based weight management strategies. Caregivers attend 4 of the 20 weekly groups with their teens. Receives: Behavioral: Behavioral Weight Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. Total scores range from 1 to 77, with higher scores indicating a greater degree of WBI.
Measured: Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
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. Total scores range from 12 to 60, with higher scores indicating a greater degree of internalized stigma.
Measured: Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
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. Total scores on the weight-related teasing sub-scale range from 6-30, with higher scores indicating a higher frequency of historical weight-based teasing.
Measured: Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
Average (AUC) for diurnal cortisol
Samples will be collected by teens at home over the course of 2 consecutive days following each assessment timepoint. A total of six samples will be collected with three samples each day: a sample immediately upon waking, another 30-60 minutes after waking, and a final sample at bedtime.
Area under the curve (AUC) will be calculated for diurnal cortisol. The average AUC over the course of two days at each assessment timepoint will be used in analyses.
Measured: Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
Concentration of c-reactive protein (CRP)
Circulating concentration of CRP will be determined using a high-sensitivity assay based on particle enhanced immunonephelometry.
Measured: Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
Concentration of interleukin-6 (IL-6)
IL-6 concentration will be determined by specific enzyme-linked immunosorbent assay.
Measured: Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
Dysregulated Eating Behaviors
Disordered eating will be measured using the 36-item Eating Disordered Examination Questionnaire.
Measured: Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
Secondary outcomes (3)
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.
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.
Measured: Post-Treatment (5 months)
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 10-50, with higher scores indicative of higher levels of intervention acceptability.
Measured: Data collected after each intervention session (20 sessions, 20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start25 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized pilot trial with active comparator
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
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
- NCT06864208
- Sponsor's protocol ID
- 1K23DK135791-02
- Acronym
- SWIFT
- Status last verified
- Jul 2026
- First submitted
- 3 Mar 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 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
- NCT06864208
- Acronym / sponsor ID
- SWIFT / 1K23DK135791-02
- Conditions
- Weight, Body Weight, Weight Bias, Weight Stigma, Physiological Stress, Biological Markers of Stress
- Keywords
- Adolescents, Teens, Weight, C-reactive protein, CRP, Interleukin-6, IL-6, Eating behaviors
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Mar 2025 (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.
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 an intervention for weight stigma and WBI combined with an evidence-based adolescent weight management program. Eligible adolescents (13-17) will be assigned by chance to one of two groups: 1) a 4-week intervention focused on weight stigma and WBI followed by a 16-week behavioral weight management program; or 2) a 4-week health information control (to include non-weight-related health promotion topics such as smoking and skin cancer prevention) followed by the same 16-week weight management program but without the WBI and weight stigma content. Study outcomes will be assessed at the 4-week and post-treatment (20 week) timepoints.
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 was previously conducted to test initial acceptability and feasibility of a newly developed 20-week WBI+BWM intervention (ClinicalTrials.gov ID: NCT06389656). The intervention consisted of 4 weeks of WBI followed by a 16-week BWM intervention with integrated WBI and weight stigma content. Quantitative and qualitative feedback concerning acceptability and feasibility were solicited to refine the intervention. The current study is a randomized trial that will compare the 20-week WBI+BWM intervention developed in the open trial to a Health Information Control (HIC) + BWM condition. The HIC+BWM intervention consists of a 4-week health information control (consisting of non-weight-related health promotion topics such as smoking and skin cancer) followed by the same 16-week BMI, but without WBI and weight stigma content.
Primary and secondary outcomes will be assessed at the 4- and 20-week (post-treatment) timepoints. This study will evaluate the impact of the interventions on WBI, biological markers of stress and inflammation (cortisol, CRP, IL-6), and dysregulated eating behaviors. Changes in weight status will also be examined. Feasibility and acceptability will be measured during the pilot RCT to ensure ongoing fit of the intervention to the adolescent population. Data will provide effect size estimates of the impact on adolescent BMI for a large-scale randomized controlled trial (RCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized pilot trial with active comparator
| Arm | Type | Receives |
|---|---|---|
| Weight Bias Internalization + Behavioral Weight Management Intervention (WBI + BWM) | Experimental | Behavioral: Behavioral Weight Management, Behavioral: Weight Bias InternalizationWBI+BWM is 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. |
| Health Information Control + Behavioral Weight Management Intervention (HIC + BWM) | Active comparator | Behavioral: Behavioral Weight ManagementThe first four sessions (weeks 1-4) of the HIC+BWM group will focus on health promotion for adolescent health concerns other than weight management (e.g., skin cancer prevention, smoking cessation). This health information control will allow for testing of the initial 4- week WBI intervention as compared to a contact-matched control. Following the four-week health education control, the remaining 16 sessions will focus on evidence-based weight management strategies. Caregivers attend 4 of the 20 weekly groups with their teens. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not 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 (4 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;
- Current use of glucagon-like peptide-1 (GLP-1) receptor agonists;
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 | Health Information Control + Behavioral Weight Management Intervention (HIC + BWM), Weight Bias Internalization + Behavioral Weight Management Intervention (WBI + BWM) |
| Weight Bias InternalizationAddressing weight stigma and improving weight-related self-perception through challenging weight-related stereotypes, practicing self-compassion, reducing self-criticism, and coping with weight stigma | Behavioural | Weight Bias Internalization + Behavioral Weight Management Intervention (WBI + BWM) |
Primary outcome
Total score on the Modified Weight Bias Internalization Scale (WBIS-M)
Time frame: Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
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. Total scores range from 1 to 77, with higher scores indicating a greater degree of WBI.
Total score on the Weight Self-Stigma Questionnaire (WSSQ)
Time frame: Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
The Weight Self-Stigma Questionnaire (WSSQ) measures weight-related self-devaluation and fear of enacted stigma. Total scores range from 12 to 60, with higher scores indicating a greater degree of internalized stigma.
Total score on the weight-related teasing sub-scale of the Perception of Teasing Scale (POTS)
Time frame: Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
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. Total scores on the weight-related teasing sub-scale range from 6-30, with higher scores indicating a higher frequency of historical weight-based teasing.
Average (AUC) for diurnal cortisol
Time frame: Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
Samples will be collected by teens at home over the course of 2 consecutive days following each assessment timepoint. A total of six samples will be collected with three samples each day: a sample immediately upon waking, another 30-60 minutes after waking, and a final sample at bedtime. Area under the curve (AUC) will be calculated for diurnal cortisol. The average AUC over the course of two days at each assessment timepoint will be used in analyses.
Concentration of c-reactive protein (CRP)
Time frame: Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
Circulating concentration of CRP will be determined using a high-sensitivity assay based on particle enhanced immunonephelometry.
Concentration of interleukin-6 (IL-6)
Time frame: Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
IL-6 concentration will be determined by specific enzyme-linked immunosorbent assay.
Dysregulated Eating Behaviors
Time frame: Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
Disordered eating will be measured using the 36-item Eating Disordered Examination Questionnaire.
3 secondary outcomes
Attendance rates at intervention sessions
Time frame: Post-Treatment (5 months)
Retention rate for intervention sessions
Time frame: Post-Treatment (5 months)
Total score on an adapted version of the Acceptability of Intervention Measure (AIM)
Time frame: Data collected after each intervention session (20 sessions, 20 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Yes
Related trials for Weight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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 Weight and Body Weight, 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 4 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: under way, not looking for participants, as of the sponsor's last update on 21 Jul 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?
This study is still under way. Results are not available in the source record yet.
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 the Modified Weight Bias Internalization Scale (WBIS-M) (time frame: Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)). The study lists 7 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 21 Jul 2026.