Body Weight Clinical Trial
— SWIFTOfficial 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.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | February 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 17 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | The Miriam Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
The Miriam Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Post-Treatment (5 months) | |
Primary | In depth qualitative feedback from teens regarding intervention acceptability and feasibility | Intervention acceptability refers to the extent to which the WBI+BWC intervention is agreeable, palatable, or satisfactory to adolescents engaging in the treatment. Adolescents will participate in individual qualitative interviews to gather in depth information concerning acceptability and feasibility. Findings will be used to tailor treatment delivery and content to optimize acceptability and appropriateness of the treatment for adolescents. | Post-Treatment (5 months) | |
Primary | 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%. | Post-Treatment (5 months) | |
Primary | 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%. | Post-Treatment (5 months) | |
Secondary | 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. | Baseline, Post-Treatment (5 months) | |
Secondary | 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. | Baseline, Post-Treatment (5 months) | |
Secondary | 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. | Baseline, Post-Treatment (5 months) | |
Secondary | Total score on the competency-related teasing subscale 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 competency-related teasing subscale range from 5-25, with higher scores indicating a greater effect of past teasing on the adolescent. | Baseline, Post-Treatment (5 months) | |
Secondary | 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. | Baseline, Post-Treatment (5 months) |
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