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Weight Loss and Physical Activity in Overweight/Obese Individuals With Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02910544
Recruitment Status : Completed
First Posted : September 22, 2016
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Henrik Gudbergsen, Parker Research Institute

Brief Summary:

This is a substudy to a randomised trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counselling, after which.they will be randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle.

This substudy aims to investigate any changes in physical activity associated with the initial 8-week weight loss intervention.


Condition or disease Intervention/treatment
Osteoarthritis, Knee Dietary Supplement: Intensive dietary intervention

Detailed Description:

The investigators aim to describe changes in physical activity associated with a significant weight loss among overweight/obese individuals with knee OA. The investigators will take advantage of the planned trial "Effect of liraglutide on body weight and pain in overweight patients with knee osteoarthritis: A randomised, double blind, placebo-controlled, parallel group, single-centre trial" (the parent trial) in which a significant weight loss is sought achieved over 8 weeks by means of intensive dietary counseling and meal replacement in overweight/obese individuals with knee OA.

The investigators hypothesize that weight loss is associated with a decrease in daily time spent physically inactive.

Physical activity is measured using accelerometer based recordings using a wearable sensor that continuously records physical activity over the entire weight loss program (8 weeks). The sensor is miniaturised, discretely worn on the thigh, and is waterproof. Thus the measurements interfere minimally with the participants daily life.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Association Between Weight Loss and Changes in Physical Activity in Overweight/Obese Individuals With Knee Osteoarthritis: An Observational Cohort Study
Study Start Date : November 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Intensive dietary intervention
Supervised dietary weight loss program lasting 8 weeks.
Dietary Supplement: Intensive dietary intervention
Participants receive a hypo-caloric formula diet containing 800 to 1,000 kcal/day. The formula diet consists of ready-to-use meal bars and powders to mix with water to make shakes, soups, or porridge. The weight loss programme consists of an 8-week period with full meal replacement by a standard liquid energy intake protocol. To facilitate compliance with the programme, participants will be scheduled for weekly facility-based group sessions with 6-8 participants led by a dietician. The recommendations for daily nutrient intake will be met.




Primary Outcome Measures :
  1. Change in time spent inactive (minutes) [ Time Frame: week -8 to week 0 ]
    Physical activity is recorded using an accelerometer based system with a built in algorithm for detection of standardised activities. Inactivity is defined as activities done sitting or lying down.



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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants eligible for parent trial (NCT02905864), i.e. overweight/obese individuals with knee osteoarthritis
Criteria

Further Inclusion Criteria:

  • Eligible for parent trial (NCT02905864)
  • Owner of a smart phone

Exclusion Criteria:

  • Known allergies against band-aids

The eligibility criteria for this sub-study (i.e. owner of a smartphone and no known allergies against Band-Aids) are not considered requirements for participation in the parent study. Nor will any violation of this sub-study protocol affect participation, care, or attention given from the parent study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910544


Locations
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Denmark
The Parker Institute
Frederiksberg, Capital Region, Denmark, 2000
Sponsors and Collaborators
Parker Research Institute
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Responsible Party: Henrik Gudbergsen, MD, PhD, Parker Research Institute
ClinicalTrials.gov Identifier: NCT02910544    
Other Study ID Numbers: 137.01
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Overweight
Weight Loss
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Body Weight
Body Weight Changes