NCT03886870

Brief Summary

The main aim of this study was to examine whether introducing a work intervention into a traditional lifestyle rehabilitation program for persons with BMI above 30, would affect the participants' ability to work and their lifestyle change. The investigators wanted to find out how the participants experienced their health, workability and work capacity, quality of life, diet and self-efficacy before and during the intervention

Trial Health

100
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable obesity

Status
completed

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

Study Start

First participant enrolled

September 3, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
Last Updated

March 22, 2019

Status Verified

March 1, 2019

Enrollment Period

3.3 years

First QC Date

March 14, 2019

Last Update Submit

March 21, 2019

Conditions

Keywords

ObesityWork FocusWorkabilityLife-style treatment

Outcome Measures

Primary Outcomes (1)

  • Full or partial return to work.

    Mapping changes in work employability and work related factors with survey data from the ARR form (http://www.arbeidoghelse.no).

    Data collected during the interventions, baseline, 6 and 12 months.

Secondary Outcomes (9)

  • Weight loss (kilograms)

    Data collected during the interventions, baseline, 6 and 12 months.

  • Return to work self-efficacy

    Data collected during the interventions, baseline, 6 and 12 months.

  • Quality of Life (15D), health-related quality of life

    Data collected during the interventions, baseline, 6 and 12 months.

  • Subjective somatic and psychological complaints

    Data collected during the interventions, baseline, 6 and 12 months.

  • Vo2 peak

    Data collected during the interventions, baseline and 12 months.

  • +4 more secondary outcomes

Study Arms (2)

Lifestyle and work intervention

EXPERIMENTAL

Lifestyle intervention with work focus.

Behavioral: Lifestyle intervention

Lifestyle intervention

EXPERIMENTAL

Lifestyle intervention without work focus.

Behavioral: Lifestyle and work intervention

Interventions

The intervention period lasted for a year with three institution-based stays, 4 weeks at baseline and 2 weeks at 6 and 12 months. At baseline, participants got a functional assessment and an individual adjusted rehabilitation plan. At all three stages: The intervention contains activity training with a focus on the joy of movement, strength- and cardio-training. There were lectures and cognitive therapy to promote self-care and lifestyle change. The intervention contained lectures on diet, nutrition and cooking-classes. Participants set goals at baseline and adjusting these during the progress. Exercise programs was designed to use at home. The Cognitive Information Processing model of career guidance was the mainframe for the work dimension. All participants had talks with the work consultant at baseline, 6 and 12 months. Two work lectures, "Duties and rights as employees" and "Work as medicine". When needed the work consultant contacted the employer in order to facilitate changes.

Lifestyle intervention

The intervention period lasted for a year with three institution-based stay, 4 weeks at baseline and 2 weeks at 6 and 12 months. At baseline, participants got a functional assessment and an individual adjusted rehabilitation plan. At all three stages: The intervention contains activity training with focus on joy of movement, strength- and cardio-training. There was lectures and cognitive therapy to promote self-care and lifestyle change. The intervention contained lectures on diet, nutrition and cooking-classes. Participants set goals at baseline and adjusting these during the progress. They developed exercise programs designed to use at home.

Lifestyle and work intervention

Eligibility Criteria

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

You may qualify if:

  • Participants with a Body Mass Index (BMI) \> 30 with or without comorbidity

You may not qualify if:

  • 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 with or plan to apply for disability benefits.
  • People with permanently adapted work.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityObesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Geir Ove Vegsund

    Muritunet

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blind masking
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The study was designed as a randomized controlled study with an exploring prospective design. The intervention lasted 12 months and each patient had three visits (baseline, 6 and 12 month) at Muritunet, each lasting 4-2-2 weeks. The participants was randomized either into a lifestyle and work intervention or into a lifestyle intervention. Data material gathered at each stay consisting of self-reported forms, test, journal and individual interviews. These were all collected at baseline, and at six and twelve months.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2019

First Posted

March 22, 2019

Study Start

September 3, 2014

Primary Completion

December 31, 2017

Study Completion

February 1, 2018

Last Updated

March 22, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Abstract and lecture: Nordic Conference in Work and Rehabilitation. Abstract and lecture: Work Disability Prevention and Integration Conference 2019 An article in BMC Public Health, 2019, qualitative results. An article, mixed methods results, 2019