NCT05708417

Brief Summary

The study aim is to evaluate a patient-centred intervention focusing on improved quality of life and wellbeing among individuals with obesity and risk factors for adverse outcome.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

First Submitted

Initial submission to the registry

January 13, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

September 26, 2024

Status Verified

September 1, 2024

Enrollment Period

3 years

First QC Date

January 13, 2023

Last Update Submit

September 25, 2024

Conditions

Health Related Quality of Life and Weight Condition

Outcome Measures

Primary Outcomes (1)

  • HRQoL .

    Measured by the questionnaire Impact of Weight on Quality of Life-Lite at week 52. Scores range from 0 to 100, with 100 representing the best quality of life.

    52 weeks

Secondary Outcomes (9)

  • General physical activity

    52 weeks

  • Body perception

    52 weeks

  • Isometric muscle strength

    52 weeks

  • Self-esteem

    52 weeks

  • Total cholesterol (mml/L)

    52 weeks

  • +4 more secondary outcomes

Study Arms (2)

Weight neutral intervention

EXPERIMENTAL

The intervention is based on the concept of Acceptance and Commitment Therapy (ACT) and is conducted by specially trained physiotherapist and a dietician. The intervention in SDOI has the predominantly focus on each individual reflection and realization and is built upon ACT' six core processes. Specific focus on teach participant with different narrative and background and on coaching and back-and-forth dialogue with physiotherapist and dietician. The program is based on up to 13 times attendance within the 12 months intervention period. Part 1: Three to five individual coaching, Part 2: six group sessions and Part 3: one or two individual coaching. Compliance to the intervention is classified as 'good' if the participants participate for a minimum four out of six group sessions, a minimum three out of five initial individual coaching and a minimum one out of two individual coaching post intervention.

Behavioral: Lifestyle Intervention

Reference group

PLACEBO COMPARATOR

The reference group will not receive the intervention in the study and only participate in the test/data collection. The reference group will established consisting of participants participating in the SDOI program but, who of some reasons have refused participating in the lifestyle program. In case of insufficient recruitment of participants to the reference group, individuals meeting inclusion criteria such as age and BMI will be recruited via advertising in local newspapers and social media.

Other: Placebo

Interventions

Lifestyle InterventionBEHAVIORAL

The intervention in SDOI has the predominantly focus on each individual reflection and realisation and is built upon ACT' six core processes: 1) Acceptance, 2) Cognitive defusion 3) Being present, 4) Self as context, 5) Values, and 6) Committed action. The program is based on up to 13 times attendance within the 12 months intervention period.

Weight neutral intervention
PlaceboOTHER

No lifestyle intervention within the study, only test/datacollection

Reference group

Eligibility Criteria

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

You may qualify if:

  • Body mass index above 30 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of Southwest Denmark

Esbjerg, Region Syddanmark, 6700, Denmark

Location

Study Officials

  • Claus Bogh Juhl, Professor

    Hospital of South West Jutland, 6700 Esbjerg , Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The study is a one-site, single-blind, clinical intervention study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2023

First Posted

February 1, 2023

Study Start

February 1, 2023

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

September 26, 2024

Record last verified: 2024-09

Locations

DK(1)