NCT03286374

Brief Summary

The main aim of this Cohort trial is to get more information about how life style changes affect work participation for people with BMI above 30. The information can contribute to improving the quality of occupational rehabilitation programs in the specialized health care services and for others who work with weight loss programs and work related rehabilitation programs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

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

August 30, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

October 23, 2020

Status Verified

October 1, 2020

Enrollment Period

2 years

First QC Date

September 12, 2017

Last Update Submit

October 22, 2020

Conditions

Keywords

ObesityOccupational rehabilitationSick leaveLife style treatment

Outcome Measures

Primary Outcomes (1)

  • Work participation

    Work participation after a work related rehabilitation program at Muritunet.

    1-4 years

Secondary Outcomes (3)

  • Life quality

    Survey data collected at baseline, six and twelve months after participation in the trial.

  • Work motivation

    Survey data collected at baseline, six and twelve months after participation in the trial.

  • Weight loss

    Weight collected at baseline, six and twelve months after participation in the trial.

Study Arms (1)

Occupational rehabilitation

OTHER

The participants will receive the current occupational rehabilitation program at Muritunet.

Behavioral: Occupational rehabilitation

Interventions

The participants in the occupational rehabilitation program get both practical and theoretical intervention in groups. Four main interventions; cognitive therapy, physical activity, diets and training in work-oriented approach. The rehabilitation stay is as followed: 1. Four weeks with an institutional stay at Muritunet (BL) 2. Follow-up; 1. Eight weeks, telephone contact between therapist at Muritunet and the participant. 2. 16 weeks, video conference on SKYPE between all the participants and a therapist. Lecture on diets. 3. 28 weeks, Follow-up at Muritunet. Central themes that day is education, conversation, physical test, and forms. (T1) 4. 40 weeks, telephone contact between therapist at Muritunet and the participant. 5. 52 weeks, Follow-up at Muritunet. Central themes that day is education, conversation, physical test, and forms. (T2)

Also known as: Life style treatment
Occupational rehabilitation

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People who are on sick leave or stands in danger of being sick because of problems related to obesity.
  • The participants must have a realistic opportunity to return to work.
  • Body mass index above 30
  • Age 18-67 years.

You may not qualify if:

  • People with a severe eating disorder.
  • People without a capacity to consent.
  • People with severe alcohol and/or drug abuse.
  • People with a major mental illness.
  • Being pregnant.
  • People with a health condition that contraindicates physical activity.
  • People who receive work assessment allowance.
  • People with or plan to apply for disability benefits.
  • People with permanently adapted work.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anita Dyb Linge

Valldal, Møre og Romsdal, 6210, Norway

Location

Related Publications (2)

  • Linge AD, Bjorkly SK, Jensen C, Hasle B. Bandura's Self-Efficacy Model Used to Explore Participants' Experiences of Health, Lifestyle, and Work After Attending a Vocational Rehabilitation Program with Lifestyle Intervention - A Focus Group Study. J Multidiscip Healthc. 2021 Dec 24;14:3533-3548. doi: 10.2147/JMDH.S334620. eCollection 2021.

  • Linge AD, Jensen C, Laake P, Bjorkly SK. Changes to body mass index, work self-efficacy, health-related quality of life, and work participation in people with obesity after vocational rehabilitation: a prospective observational study. BMC Public Health. 2021 May 17;21(1):936. doi: 10.1186/s12889-021-10954-y.

MeSH Terms

Conditions

Obesity, MorbidObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Odd Ragnar Hunnes, Dean

    Volda University Collage

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Due to the nature of the study intervention, it is not possible to blind the participants. Some of the participants will give a focus group interview and their identity will be known for the other participants in the group. The health care providers will not get information about who will participate or not.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: The study is a Clinical cohort trial with a pseudo prospective, parallel mixed methods design. Questionnaires and register data at baseline, T1, and T2. Focus group interviews at T3, and register data at T4.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D Student

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 18, 2017

Study Start

August 30, 2017

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

October 23, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations