Behavioral Program for Obesity

(SWIFT Trial)

Overseen By Andrea M Grenga, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The Miriam Hospital

Disqualifiers: Cognitive impairment, Developmental delay, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

Duration: 20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist teens struggling with weight stigma and weight bias internalization (WBI), which can impact both mental and physical health. Participants will engage in a 20-week program that combines strategies to manage WBI and enhance overall weight-related health. A behavioral expert will lead weekly meetings, initially focusing on WBI and then expanding to broader weight management. Teens aged 13-17 with a BMI above the 95th percentile, who speak English, and have a caregiver willing to participate, may be suitable candidates. The goal is to evaluate the program's practicality and acceptability for participants. As an unphased trial, this study provides a unique opportunity for teens to contribute to significant research that could enhance support for others facing similar challenges.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this behavioral program is safe for adolescents?

Research has shown that internalizing weight bias can negatively affect mental and physical health, leading to conditions such as depression and anxiety. However, limited information exists about the safety of treatments targeting this issue. This trial is labeled "Not Applicable" for its phase, indicating that the treatment is likely in the early stages of development for this specific purpose. Consequently, detailed safety information might not yet be fully available.

Generally, behavioral programs like the one being tested are considered low-risk compared to traditional medical treatments. They focus on changing behavior and mindset rather than using medication or surgery. While specific safety details for this weight bias intervention are not provided, these types of programs are usually well-tolerated. Participants might experience some emotional discomfort when discussing sensitive topics, but this is typically a normal part of the process.

Overall, although specific safety data for this intervention is unavailable, the nature of behavioral treatments suggests they are relatively safe, with minimal physical risk involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Behavioral Program for Obesity because it combines both psychological and physical approaches to tackle weight issues in adolescents. Unlike typical weight loss programs that mainly focus on diet and exercise, this program addresses weight bias internalization—helping teens deal with the stigma and internalized negativity about their weight. By integrating sessions on both weight stigma and evidence-based weight management strategies, the program offers a comprehensive approach that could potentially lead to more sustainable results. The involvement of caregivers in some sessions also means there's support at home, which can be crucial for long-term success.

What evidence suggests that this program is effective for weight bias internalization and weight management?

Research shows that feeling bad about one's weight can harm both physical and mental health. Studies have found that facing weight-related stigma links to more mental health problems and unhealthy eating habits. In this trial, the WBI+BWM treatment arm combines weight management with efforts to address these negative feelings, aiming to improve overall health. This approach seeks to lessen the harmful effects of feeling bad about one's weight and encourage healthier habits. Early evidence suggests that focusing on these feelings can help teenagers manage their weight better and improve their mental well-being. ^{2 4 6 7 8}

Who Is on the Research Team?

Katherine Darling, PhD

Principal Investigator

The Miriam Hospital

Are You a Good Fit for This Trial?

This trial is for adolescents aged 13-17 who experience weight discrimination and have a higher weight status. The focus is on those willing to participate in a 20-week program designed to address weight bias internalization (WBI) and improve health behaviors.

Inclusion Criteria

My BMI is in the top 5% for my age and gender.

I am between 13 and 17 years old.

Must have at least one caregiver available to provide consent and participate in sessions

Exclusion Criteria

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

I have cognitive issues that make group activities challenging.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 20-week intervention focused on weight bias internalization and healthy weight management strategies

20 weeks

20 weekly sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Weight Bias Internalization

Trial Overview

The study tests an intervention aimed at reducing the negative effects of WBI while participating in an established adolescent weight management program. Success will be measured by how feasible and acceptable participants find this combined approach after the program ends.

How Is the Trial Designed?

Group I: WBI+BWM Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

The Miriam Hospital

Lead Sponsor

Trials

252

Recruited

39,200+

Published Research Related to This Trial

In a study of 18,769 adults in a commercial weight management program, weight bias internalization (WBI) was found to be relatively high, indicating that many individuals internalize negative societal attitudes about weight, with an average WBIS-M score of 4.3.

WBI was notably higher among younger, female participants with higher BMIs, while it was lower in Black individuals and those with romantic partners, suggesting that demographic factors and the timing of weight stigma experiences play a significant role in WBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight bias internalization in a commercial weight management sample: prevalence and correlates. Pearl, RL., Himmelstein, MS., Puhl, RM., et al.[2023]

The Weight Self-Stigma Questionnaire (WSSQ) and Weight Bias Internalization Scale (WBIS) were validated for use in Asian pediatric populations aged 8 to 12 years, showing their effectiveness in assessing internalized weight bias.

While both instruments are valid, the WSSQ showed consistent measurement across gender and weight status, whereas the WBIS was only consistent across gender, indicating that they should be used in different contexts for accurate assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric properties and measurement invariance of the Weight Self-Stigma Questionnaire and Weight Bias Internalization Scale in children and adolescents. Pakpour, AH., Tsai, MC., Lin, YC., et al.[2022]

A cognitive-behavioral intervention aimed at reducing weight bias internalization (WBI) combined with behavioral weight loss (BWL) showed short-term benefits in reducing self-stigma related to weight, particularly in self-devaluation, but did not significantly differ in overall weight loss compared to BWL alone.

Participants in the BWL + BIAS group experienced greater improvements in measures of eating behaviors and self-monitoring, indicating that addressing psychological aspects of weight bias may enhance certain behavioral outcomes, even if overall weight loss was similar between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a cognitive-behavioral intervention targeting weight stigma: A randomized controlled trial. Pearl, RL., Wadden, TA., Bach, C., et al.[2021]

The study confirmed that the Weight-Bias Internalization Scale (WBIS) is a reliable tool for measuring internalized weight bias in bariatric patients, showing a strong association with negative psychosocial outcomes such as body dissatisfaction, depression, and anxiety.

Higher levels of internalized weight bias were linked to poorer quality of life and disordered eating behaviors, indicating that addressing IWB could be crucial for improving the overall well-being of patients undergoing bariatric surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internalized weight bias in patients presenting for bariatric surgery. Wagner, AF., Butt, M., Rigby, A.[2021]

A study of 1,061 children aged 9-13 found that a weight bias internalization (WBI) score of 1.55 or higher significantly increases the risk of disturbed eating behaviors and is a better indicator of these behaviors than relative weight status.

Children with higher WBI scores also reported more depressive and anxious symptoms, greater body dissatisfaction, and lower self-esteem, highlighting the importance of addressing WBI in mental health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simply too much: the extent to which weight bias internalization results in a higher risk of eating disorders and psychosocial problems. Gmeiner, MS., Warschburger, P.[2022]

A study involving 72 adults with obesity and elevated weight bias internalization (WBI) found that a combined cognitive behavioral intervention and behavioral weight loss (BWL) did not lead to significant differences in reductions of WBI compared to BWL alone after 6 months.

Participants in the BWL + BIAS group reported better improvements in eating behaviors and coping with weight stigma, but overall weight loss was similar between both groups, indicating that while stigma reduction may help with coping, it did not significantly enhance weight loss outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six-Month Follow-up from a Randomized Controlled Trial of the Weight BIAS Program. Pearl, RL., Wadden, TA., Bach, C., et al.[2021]

Internalized weight bias (IWB) is a significant issue among children and adolescents, with 24 studies identifying its measurement through two main instruments: the Weight Bias Internalization Scale and the Weight Self Stigma Questionnaire.

IWB is linked to negative outcomes in mental health, physical health, social functioning, and maladaptive eating behaviors, highlighting the need for awareness and intervention in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment and impact of paediatric internalized weight bias: A systematic review. Butt, M., Harvey, A., Khesroh, E., et al.[2023]

The Weight Bias Internalization Scale (WBIS) demonstrated better reliability and predictive validity for psychosocial health outcomes compared to the Weight Self-Stigma Questionnaire (WSSQ) in a study of 78 prebariatric surgery patients.

Both the WSSQ and WBIS are effective tools for assessing internalized weight stigma, correlating significantly with factors like body image, quality of life, self-esteem, depression, and anxiety, but the WBIS was more strongly associated with self-esteem outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Self-Report Measures of Internalized Weight Stigma: The Weight Self-Stigma Questionnaire versus the Weight Bias Internalization Scale. Hübner, C., Schmidt, R., Selle, J., et al.[2022]

The Weight Bias Internalization Scale (WBIS) was developed and validated as a reliable tool to measure internalized weight bias among overweight and obese individuals, showing high internal consistency (Cronbach's alpha = 0.90).

Internalized weight bias, as measured by the WBIS, significantly correlates with negative outcomes such as low self-esteem, body image concerns, and mood disturbances, indicating its potential impact on mental health and eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding self-directed stigma: development of the weight bias internalization scale. Durso, LE., Latner, JD.[2022]

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