NCT06462300

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 17, 2024

Completed
Last Updated

June 17, 2024

Status Verified

June 1, 2024

Enrollment Period

1.3 years

First QC Date

June 3, 2024

Last Update Submit

June 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Meaning in life

    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 Outcomes (8)

  • Tripartite domain of meaning in life: Comprehension

    Baseline (week 1), post-assessment (week 7), follow-up (week 11)

  • Tripartite domain of meaning in life: Purpose

    Baseline (week 1), post-assessment (week 7), follow-up (week 11)

  • Tripartite domain of meaning in life: Mattering

    Baseline (week 1), post-assessment (week 7), follow-up (week 11)

  • Eating disorder symptoms

    Baseline (week 1), post-assessment (week 7), follow-up (week 11)

  • Internalizing symptoms

    Baseline (week 1), post-assessment (week 7), follow-up (week 11)

  • +3 more secondary outcomes

Study Arms (2)

Meaning-centered intervention condition

EXPERIMENTAL

The group of participants receiving the meaning-centered intervention

Behavioral: A meaning-centered intervention for young women with weight and shape concerns

Waitlist control condition

NO INTERVENTION

The group of participants not receiving an intervention

Interventions

* adapted version of the manualized meaning-centered psychotherapy for cancer patients developed by van der Spek et al. (2017) * six weekly individual online sessions, each lasting one hour * sessions led by a certified trainer * four sources of meaning will be explored: personal life story, dealing with life's limitations, creating one's own life, and meaningful experiences * homework assignments designed to deepen participants' experience and reflection on meaning in their daily lives

Meaning-centered intervention condition

Eligibility Criteria

Age16 Years - 35 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsParticipants had to indicate "woman" as their preferred gender identity during the screening process.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Current treatment for eating disorder
  • not fluent in English, Dutch, or German

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Groningen

Groningen, 9712TS, Netherlands

Location

MeSH Terms

Interventions

Weights and Measures

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2024

First Posted

June 17, 2024

Study Start

October 20, 2022

Primary Completion

February 6, 2024

Study Completion

February 6, 2024

Last Updated

June 17, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

All IPD that underlies the results in the finalized publication will be made available

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Time Frame
Starting 6 months after publication
Access Criteria
Access will be given based on individual requests

Locations