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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Parker Institute

Frederiksberg, Capital Region, 2000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intensive dietary intervention

Dietary Supplement

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Parker Research Institute

Other

Registry information

Official study title

The Association Between Weight Loss and Changes in Physical Activity in Overweight/Obese Individuals With Knee Osteoarthritis: An Observational Cohort Study

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2018
First posted: Sep 22, 2016
Registry last updated: Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed