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

NCT02910544 | Completed DMC

• 1 other identifier: 137.01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Intensive dietary intervention

Supervised dietary weight loss program lasting 8 weeks.

Dietary Supplement: Intensive dietary intervention

Interventions

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.

Intensive dietary intervention

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parker Research Institute: lead

Study Sites (1)

The Parker Institute

Frederiksberg, Capital Region, 2000, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 22, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: March 25, 2019

Record last verified: 2019-03

Locations

DK (1)