NCT05529758

Brief Summary

The current study aims to test a third-wave based IWB intervention paired with a standard BWLP delivered through video conferencing software.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

9 months

First QC Date

August 19, 2022

Last Update Submit

March 3, 2024

Conditions

Keywords

Behavioral Weight Loss Program

Outcome Measures

Primary Outcomes (6)

  • Weight Change

    Weight Change

    Baseline to Week 10

  • Weight Bias Internalization Scale

    Internalized Weight Bias, which is internalizing weight bias towards oneself, is scored on a scale of 1 to 7, with higher scores indicating greater weight bias internalization.

    Baseline to Week 10

  • Weight Self-Stigma Questionnaire

    Internalized Weight Bias, which is internalizing weight bias towards oneself, is summed on a scale of 12 to 60, with higher scores indicating greater weight bias internalization. Includes two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FNE), each summed on scale of 6-30.

    Baseline to Week 10

  • Revised Morgenstern Physical Activity Questionnaire (PAQ-M)

    The Revised Morgenstern Physical Activity Questionnaire assesses Physical Activity through 11 items, asking participants specifically about light, moderate, or rigorous exercise, recreational activities, home, volunteer, or work activities, and chores.

    Baseline to Week 10

  • Diet History Questionnaire III (DHQ III)

    The Diet History Questionnaire III assesses Eating Behavior, including various food items/groups (with 124 food items) and frequency and portion of each food item or group.

    Baseline to Week 10

  • Three Factor Eating Questionnaire-R18 (TFEQ-18)

    The Three Factor Eating Questionnaire-R18 is an 18-item measure designed to examine eating behavior through three subscales: cognitive restraint, uncontrolled eating and emotional eating using a 4-point Likert scale, using "definitely true" to "definitely false". Higher scores indicate more disordered eating.

    Baseline to Week 10

Secondary Outcomes (9)

  • Self-Compassion Scale

    Baseline to Week 10

  • Brief Stigmatizing Situations Inventory

    Baseline to Week 10

  • Depression Anxiety and Stress Scale - 21 Items (DASS-21)

    Baseline to Week 10

  • Rosenberg Self-Esteem Scale

    Baseline to Week 10

  • The Acceptance and Action Questionnaire - Second Edition (AAQ-II)

    Baseline to Week 10

  • +4 more secondary outcomes

Study Arms (1)

Intervention Group

EXPERIMENTAL

Receives internalized weight bias intervention along with standard behavioral weight loss program

Behavioral: Internalized Weight Bias Intervention

Interventions

ACT-based programs and self-compassion have shown promise throughout research for lowering IWB (Berman et al., 2016; Levin et al., 2018; Lillis et al., 2009; Palmeira, Cunha, \& Pinto-Gouveia, 2017; Palmeira, Pinto-Gouveia, \& Cunha, 2017; Forbes et al., 2020). Therefore, using techniques from prior ACT- and self-compassion based programs, a weight bias reduction intervention will be administered. Session topics will include psychoeducation and coping for weight bias and internal weight bias, and these topics will be viewed through a self-compassionate and ACT-based lens (for example, participants may defuse from internal critical thoughts rather than challenge them). Sessions will also cover acceptance, cognitive defusion, mindfulness, committed action, and the dialectical behavioral therapy (DBT) DEARMAN skill.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Interested in weight loss
  • or older
  • BMI of 25 kg/m2 or greater
  • Higher-than-average levels of IWB
  • Access to internet, along with a web camera and sound, and be able to use video conferencing software and attend weekly online groups, and access to a reliable scale to weigh themselves weekly

You may not qualify if:

  • Individuals with current use of medication prescribed for weight loss (such as orlistat, sibutramine, or rimonabant)
  • Pregnant or planning to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Carolina University

Greenville, North Carolina, 27858, United States

Location

MeSH Terms

Conditions

Weight LossWeight Prejudice

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPrejudiceSocial BehaviorBehavior

Study Officials

  • Julia C Miller, MA

    East Carolina University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

August 19, 2022

First Posted

September 7, 2022

Study Start

August 15, 2022

Primary Completion

May 15, 2023

Study Completion

August 15, 2023

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Participant data will be kept confidential.

Locations