- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06462300
Meaning-centered Intervention for Young Women With Weight and Shape Concerns
Searching for Meaning: A Study Examining the Effect of a Meaning-centered Intervention
Female participants with weight and shape concerns will either receive a six-week meaning-centered intervention led by a trainer or be allocated to a waitlist condition. They will receive the same questionnaires at three time points: Before the intervention, immediately after, and four weeks later.
The researchers hypothesize that a meaning-centered intervention for young women with weight and shape issues will increase participants meaning in life and decrease their eating disorder symptoms immediately after the intervention and at 4-week follow-up when compared to a waitlist condition.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Groningen, Netherlands, 9712TS
- University of Groningen
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- When screened with the Weight Concerns Scale (WCS; Killen et al., 1994) and when scores of all five items were adjusted to equal a maximum score of 20, leading to a total range between 0 and 100 (cf. Jacobi et al., 2004), participant are eligible if they answer "always" or "often" to the item "Do you ever feel fat?" or have a total score ≥ 47 on the WCS or both
Exclusion Criteria:
- Current treatment for eating disorder
- not fluent in English, Dutch, or German
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Meaning-centered intervention condition
The group of participants receiving the meaning-centered intervention
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|
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No Intervention: Waitlist control condition
The group of participants not receiving an intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Meaning in life
Time Frame: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
|
Presence of meaning in life subscale of Meaning in Life Questionnaire (Steger et al., 2006); average of 5 items with 7-point Likert scale (minimum: 1; maximum 7); the higher the score, the higher the presence of life meaning
|
Baseline (week 1), post-assessment (week 7), follow-up (week 11)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tripartite domain of meaning in life: Comprehension
Time Frame: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
|
Comprehension subscale of Multidimensional Existential Meaning Measure (George & Park, 2016); average of 5 items on 7-point Likert scale (minimum: 1; maximum: 7); the higher the score, the higher the sense of Comprehension
|
Baseline (week 1), post-assessment (week 7), follow-up (week 11)
|
|
Tripartite domain of meaning in life: Purpose
Time Frame: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
|
Purpose subscale of Multidimensional Existential Meaning Measure (George & Park, 2016); average of 5 items on 7-point Likert scale (minimum: 1; maximum: 7); the higher the score, the higher the sense of Purpose
|
Baseline (week 1), post-assessment (week 7), follow-up (week 11)
|
|
Tripartite domain of meaning in life: Mattering
Time Frame: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
|
Mattering subscale of Multidimensional Existential Meaning Measure (George & Park, 2016); average of 5 items on 7-point Likert scale (minimum: 1; maximum: 7); the higher the score, the higher the sense of Mattering
|
Baseline (week 1), post-assessment (week 7), follow-up (week 11)
|
|
Eating disorder symptoms
Time Frame: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
|
Global score of Eating Disorder Examination-Questionnaire (Fairburn & Beglin, 2008); average score of 22 items on a 7-point Likert scale (minimum: 0; maximum: 6); the higher the score, the more severe the eating disorder symptomatology
|
Baseline (week 1), post-assessment (week 7), follow-up (week 11)
|
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Internalizing symptoms
Time Frame: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
|
Total score of Depression Anxiety Stress Scales-21 (Lovibond & Lovibond, 1995); sum score of 21 items on a 4-point Likert scale (minimum: 0; maximum: 63); the higher the score, the more severe the internalizing symptomatology
|
Baseline (week 1), post-assessment (week 7), follow-up (week 11)
|
|
Depressive symptoms
Time Frame: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
|
Depression subscale of Depression Anxiety Stress Scales-21 (Lovibond & Lovibond, 1995); sum score of 7 items on a 4-point Likert scale (minimum: 0; maximum: 21); the higher the score, the more severe the depressive symptomatology
|
Baseline (week 1), post-assessment (week 7), follow-up (week 11)
|
|
Anxiety symptoms
Time Frame: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
|
Anxiety subscale of Depression Anxiety Stress Scales-21 (Lovibond & Lovibond, 1995); sum score of 7 items on a 4-point Likert scale (minimum: 0; maximum: 21); the higher the score, the more severe the anxiety symptoms
|
Baseline (week 1), post-assessment (week 7), follow-up (week 11)
|
|
Stress symptoms
Time Frame: Baseline (week 1), post-assessment (week 7), follow-up (week 11)
|
Stress subscale of Depression Anxiety Stress Scales-21 (Lovibond & Lovibond, 1995); sum score of 7 items on a 4-point Likert scale (minimum: 0; maximum: 21); the higher the score, the more severe the stress symptoms
|
Baseline (week 1), post-assessment (week 7), follow-up (week 11)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSY-2223-S-0010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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