Completed

ROCCKWeight Loss Impact on Knee Health in Obese Adults

Study Aim

This study aims to evaluate how weight loss affects the health of your knees, specifically focusing on changes in cartilage strain and thickness over a period of 3 and 6 months, using MRI scans.

What is being tested

Weight Loss

Behavioral

Who is being recruted

Arthritis+13

+ Body Weight

+ Body Weight Changes

From 18 to 45 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: June 2020

See protocol details

Summary

Principal SponsorDuke University

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 5, 2020

Actual date on which the first participant was enrolled.

This study focuses on reducing obesity and its impact on knee cartilage. It aims to enroll 70 participants, divided into a weight loss group and a weight maintenance group. The study is designed for individuals aged 18 to 45 with a body mass index (BMI) between 29 and 40, who have no history of lower extremity injury or symptoms of osteoarthritis (OA). Participants must also have neutral knee alignment. The goal is to understand how weight loss might help reduce strain on knee cartilage, potentially improving care for those with obesity-related knee issues. Participants will be asked about their health history and their height and weight will be recorded to calculate their BMI. If they meet the study criteria, they will be invited to join. The study will use MRI scans to measure changes in cartilage thickness and strain at 3 and 6 months. This non-invasive method helps track the effects of weight loss on knee health. Participants will be informed of all risks involved before they decide to take part in the study.

Official TitleReducing Obesity and Cartilage Compression in Knees

NCT04730557

Principal SponsorDuke University

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

88 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisBody WeightBody Weight ChangesJoint DiseasesMusculoskeletal DiseasesNutrition DisordersNutritional and Metabolic DiseasesObesityOsteoarthritisRheumatic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsWeight LossOsteoarthritis, KneeOvernutritionOverweight

Criteria

2 inclusion criteria required to participate

BMI (BMI ≥29 - <40)

Age between 18 - 45

7 exclusion criteria prevent from participating

History of lower extremity injury

Evidence of symptoms of knee OA

Knee misalignment

Evidence of pregnancy

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants in the weight-loss intervention arm of the study will be enrolled in an individualized 6-month intervention designed to achieve a 10% reduction of body weight relative to baseline. Each participant receives a calorie (kcal) prescription derived from calculations of estimated total energy expenditure (TEE) based on weight, height, sex, age, and activity level using equations developed by the Institute of Medicine \[29\]. Prescribed kcal levels are adjusted downward from the TEE to achieve a weekly weight loss of 1 to 2 pounds, generally a deficit of 500-1000 kcal/day. Intervention activities include individual diet counseling, group support, goal setting, self-monitoring, stress management, and problem solving. Weekly group support and education sessions, along with daily food journaling and weekly weigh-ins, are recognized approaches for successful weight loss \[30-32\]. Once the weight loss goal is achieved, diets will be liberalized for weight maintenance.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Duke University Medical Center

Durham, United StatesOpen Duke University Medical Center in Google Maps

CompletedOne Study Center