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

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Dietary Supplement: Intensive dietary intervention

• Registration Number: NCT02910544
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2016-09-20
• Study First Submitted QC: 2016-09-21
• Study First Posted: 2016-09-22
• Study Start: 2016-11
• Primary Completion: 2017-12
• Study Completion: 2018-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intensive dietary intervention	Intensive dietary intervention	Supervised dietary weight loss program lasting 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change in time spent inactive (minutes)	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.

Trial Locations

Locations (1)

The Parker Institute; 🇩🇰 Frederiksberg, Capital Region, Denmark