Addressing Weight Bias Internalization to Improve Adolescent Weight Management Outcomes: Randomized Pilot Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorThe Miriam Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Behavioral Weight Management

    Behavioral

    Prescription of diet and physical activity strategies paired with behavioral strategies for weight management

  • Weight Bias Internalization

    Behavioral

    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

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Weight Bias Internalization + Behavioral Weight Management Intervention (WBI + BWM)Experimental treatment 2 interventions
Group B: Health Information Control + Behavioral Weight Management Intervention (HIC + BWM)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
2

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.

Time frame
Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
3

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.

Time frame
Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
4

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.

Time frame
Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)

Secondary outcomes

1

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.

Time frame
Post-Treatment (5 months)
2

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.

Time frame
Post-Treatment (5 months)
3

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.

Time frame
Data collected after each intervention session (20 sessions, 20 weeks)

Other outcomes

1

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.

Time frame
Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.