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

Primary Purpose

Health Related Quality of Life and Weight Condition

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Lifestyle Intervention
Placebo
Sponsored by
Hospital of South West Jutland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Health Related Quality of Life and Weight Condition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital of Southwest Denmark

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Weight neutral intervention

Reference group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

General physical activity
Measured by Accelerometer
Body perception
Questionnaire
Isometric muscle strength
Measured by Biodex dynanometer
Self-esteem
Measured by questionnaire
Total cholesterol (mml/L)
Blood sample
Insulin resistance (HOMA-IR)
Blood sample
Diastolic and systolic Blood pressure (mm Hg)
Blood pressure monitor
Perceived chronic pain
Measured on VAS scale. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100
Aerobic capacity
One-point Åstrand test

Full Information

First Posted
January 13, 2023
Last Updated
March 13, 2023
Sponsor
Hospital of South West Jutland
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1. Study Identification

Unique Protocol Identification Number
NCT05708417
Brief Title
A Weight-Neutral Approach for a Healthier Lifestyle Among Obesity - A Lifestyle Intervention Anchored in SDOI
Official Title
A Weight-Neutral Approach for a Healthier Lifestyle Among Obesity - A Lifestyle Intervention Anchored in The South Danish Obesity Initiative (SDOI).
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
February 1, 2026 (Anticipated)
Study Completion Date
February 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital of South West Jutland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Related Quality of Life and Weight Condition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study is a one-site, single-blind, clinical intervention study.
Masking
Investigator
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Weight neutral intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Reference group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Intervention
Intervention Description
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
Other
Intervention Name(s)
Placebo
Intervention Description
No lifestyle intervention within the study, only test/datacollection
Primary Outcome Measure Information:
Title
HRQoL .
Description
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.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
General physical activity
Description
Measured by Accelerometer
Time Frame
52 weeks
Title
Body perception
Description
Questionnaire
Time Frame
52 weeks
Title
Isometric muscle strength
Description
Measured by Biodex dynanometer
Time Frame
52 weeks
Title
Self-esteem
Description
Measured by questionnaire
Time Frame
52 weeks
Title
Total cholesterol (mml/L)
Description
Blood sample
Time Frame
52 weeks
Title
Insulin resistance (HOMA-IR)
Description
Blood sample
Time Frame
52 weeks
Title
Diastolic and systolic Blood pressure (mm Hg)
Description
Blood pressure monitor
Time Frame
52 weeks
Title
Perceived chronic pain
Description
Measured on VAS scale. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100
Time Frame
52 weeks
Title
Aerobic capacity
Description
One-point Åstrand test
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus Bogh Juhl, Professor
Organizational Affiliation
Hospital of South West Jutland, 6700 Esbjerg , Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Hospital of Southwest Denmark
City
Esbjerg
State/Province
Region Of Southern Denmark
ZIP/Postal Code
6700
Country
Denmark

12. IPD Sharing Statement

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

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