A Weight-Neutral Approach for a Healthier Lifestyle Among Obesity - A Lifestyle Intervention Anchored in SDOI

NCT ID: NCT05708417

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2026-02-01

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.

Detailed Description

In Denmark, University Hospital of Southern Denmark in Esbjerg has initiated The South Danish Obesity Initiative (SDOI) to optimize the treatment of and the research in obesity. The hospital has for years, offered treatment to individuals with obesity, however, SDOI is an investigation program with the aim to identify people with undiagnosed obesity-related diseases by a systematic and stepwise approach, delivering an up-to-date treatment of diagnosed diseases and offering personalized lifestyle advice based on the finding in the investigation program. The SDOI program comprises collaboration between different medical departments at the hospital and furthermore, entails the establishment of a well-defined cohort as a basis for research. ACT is of interest in the construction of the personalized lifestyle advice in the SDOI program. However, there is limited research available on the effect of the behaviour therapy ACT as a basic method for a lifestyle program targeting overweight individuals who have been made aware of obesity related diseases and re-conditions. ACT might be a valuable tool to assist these individuals to increase their quality of life and thereby, ability to make lifestyle changes.

Conditions

Health Related Quality of Life and Weight Condition

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Weight neutral intervention

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.

Group Type: EXPERIMENTAL

Lifestyle Intervention

Intervention Type: BEHAVIORAL

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.

Reference group

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

No lifestyle intervention within the study, only test/datacollection

Interventions

Lifestyle Intervention

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.

Intervention Type: BEHAVIORAL

Placebo

No lifestyle intervention within the study, only test/datacollection

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participants will be eligible for inclusion if they are ≥18 years
• Body mass index above 30 kg/m2

Exclusion Criteria

• Individuals referred for bariatric surgery will not be eligible for inclusion in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claus Bogh Juhl, Professor

Role: STUDY_DIRECTOR

Hospital of South West Jutland, 6700 Esbjerg , Denmark

Locations

Hospital of Southwest Denmark

Esbjerg, Region Syddanmark, Denmark

Countries

Denmark

Other Identifiers

Lifestyle_intervention_SDOI

Identifier Type: -

Identifier Source: org_study_id