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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Denmark
  • Capital Region
    • Frederiksberg, Capital Region, Denmark, 2000
      • The Parker Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants eligible for parent trial (NCT02905864), i.e. overweight/obese individuals with knee osteoarthritis

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in time spent inactive (minutes)	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.	week -8 to week 0

Collaborators and Investigators

• Sponsor: Parker Research Institute

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: September 20, 2016
• First Submitted That Met QC Criteria: September 21, 2016
• First Posted (Estimate): September 22, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Body Weight Changes; Osteoarthritis; Osteoarthritis, Knee; Weight Loss; Overweight
• Other Study ID Numbers: 137.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED