ClinicalTrials.gg
Status unknownNCT05987306Updated Nov 14, 2023

A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss

An interventional study of Weight loss plus self-compassion in Overweight and Obesity, sponsored by East Carolina University. Status unknown at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-14.

Sponsored by East Carolina University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The goal of clinical trial is to test a novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises in overweight adults with moderate to high levels of internalized weight bias. The main question[s] it aims to answer are: 1) Can participants lose significant weight loss and 2) significantly reduce internalized weight bias. Participants will take part in a 12 week novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises using videoconferencing software.

Read the detailed description

The goal of clinical trial is to test a novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises in overweight adults with moderate to high levels of internalized weight bias. The main question[s] it aims to answer are: 1) Can participants lose significant weight loss and 2) significantly reduce internalized weight bias. Participants will take part in a 12-week novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises using videoconferencing software. The weight loss approach will be modeled after the Diabetes Prevention Program and the approach utilized to reduce internalized weight bias will be Kristen Neff's self-compassion intervention. Each weekly session will utilize Webex videoconferencing software and last approximately 60-90 minutes.

02

Conditions studied

  • Overweight and Obesity
03

In context

Overweight

3,771 studies on the registry are indexed under Overweight; 863 are open to participants now.

This study's planned enrollment of 60 is below the median of 73 across 3,263 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

East Carolina University is the lead sponsor of 84 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • BMI ≥ 25, ≥ 18 years old
  • Smartphone access
  • WBIS score ≥ 4

Exclusion criteria

Exclusion Criteria:

  • Type I diabetes, uncontrolled hypertension, cardiovascular event in past year, any major active kidney, liver, cardio, or cerebrovascular disease,
  • musculoskeletal problems that would prevent physical activity,
  • current weight loss medication or weight loss program,
  • history of bariatric surgery,
  • pregnant or breastfeeding,
  • eating disorder except binge eating disorder
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Intervention

    a standard weight loss and internalized weight bias intervention with self-compassion exercises

    Behavioral: Weight loss plus self-compassion

Interventions

  • BehavioralWeight loss plus self-compassion

    A novel weight loss approach combining a standard weight loss based on the Diabetes Prevention Program and internalized weight bias intervention with self-compassion exercises.

06

What researchers measure

Primary outcomes

  1. Weight (lbs)

    Change in weight or percent body weight

    Time frame: 12 weeks

  2. Weight Bias Internalization Scale

    Change in internalized weight bias (range 1-7 with higher scores indicating greater internalized weight bias)

    Time frame: 12 weeks

07

Study locations

1 of 2 sites recruiting
  • East Carolina University
    Greenville, North Carolina 27858, United States
    Not yet recruiting
  • ECU, Dept of Psychology, 104 Rawl
    Greenville, North Carolina 27858, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — I am happy to make data available to qualified researchers.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2023 (actual). Primary completion is estimated for May 2024, 7 months after the start.

Of 1,356 non-industry interventional studies with no phase under Overweight, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's planned 7 months is below that.

Counting every sponsor, half of 1,472 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 25, 2023
First posted
Aug 14, 2023
StartActual
Sep 24, 2023
Primary completionEst.
May 1, 2024
CompletionEst.
May 1, 2024
Last update
Nov 14, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05987306
Lead sponsor
East Carolina University
Collaborators
University of South Alabama
Responsible party
Sponsor
First posted
Aug 14, 2023
Start date
Sep 24, 2023
Primary completion
May 1, 2024 (estimated)
Completion
May 1, 2024 (estimated)
Last update
Nov 14, 2023

Study contacts

Robert Carels
Contact
carelsr14@ecu.edu
4193782704
Abbie Metzler
Contact
Robert Carels
principal investigator · East Carolina University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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