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Weight Loss for Knee Health in Obese Individuals (ROCCK Trial)
N/A
Waitlist Available
Led By Lou DeFrate
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, and 6 months
Awards & highlights
ROCCK Trial Summary
This trial is testing whether obesity affects cartilage composition and function, and whether weight loss can help restore these things. It will involve people who are 18-45 years old and obese, and require MR Imaging, evaluation of joint loading, cartilage strain measurement, and participation in a weight loss intervention.
Who is the study for?
This trial is for adults aged 18-45 with obesity (BMI of 29 to less than 40) who do not have symptoms of knee osteoarthritis, no history of lower extremity injury, and can fit in an MRI machine. Pregnant individuals or those with metal implants are excluded.Check my eligibility
What is being tested?
The study investigates if weight loss can restore cartilage composition and function in obese individuals. Participants will undergo MR Imaging, gait analysis for joint loading, cartilage strain measurement, and a weight loss program.See study design
What are the potential side effects?
Potential side effects may include discomfort from MRI procedures or physical assessments. The weight loss intervention might cause fatigue, nutritional deficiencies if not monitored properly, muscle soreness, and psychological stress.
ROCCK Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months, and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cartilage
Secondary outcome measures
Change from baseline in 6-minute walk (meters) at 3 and 6 months
Change from baseline in biomarkers of insulin resistance and beta-cell function at 3 and 6 months
Change from baseline in body weight at 3 and 6 months
+16 moreROCCK Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Weight-LossExperimental Treatment1 Intervention
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.
Group II: Wellness EducationActive Control1 Intervention
Control participants will be counseled to maintain their baseline body weight and level of physical activity. They will report weights weekly and if their weight deviates from baseline they will be asked to keep daily food logs and counseled to return calorie intakes to weight maintenance level. To document diet intakes/adherence, 3-day food records will be collected at months 0, 3, and 6 and analyzed for calorie and nutrient composition. Participants will be encouraged not to change their physical activity levels from baseline and their activity will be monitored by Actigraph activity monitors worn in 7-day periods at months 0, 3, and 6. In addition, each participant will be invited to enter the weight loss intervention after completion of the health education control course.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Weight Loss
2008
Completed Phase 3
~1460
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,419,981 Total Patients Enrolled
81 Trials studying Obesity
31,681 Patients Enrolled for Obesity
Lou DeFratePrincipal InvestigatorDuke University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience symptoms of knee arthritis.My thigh does not fit in the MRI machine.I am between 18 and 45 years old.I have had an injury to my leg.My knee is not properly aligned.I have metal implants in my body.I am between 18 and 45 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Weight-Loss
- Group 2: Wellness Education
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obesity Patient Testimony for trial: Trial Name: NCT04730557 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being accepted into this research program?
"Affirmative. The clinical trial information located on clinicaltrials.gov affirms that this research is currently enrolling participants; the study was originally posted on June 5th 2020 and recently updated on September 9th 2022. There are 100 patients needed from one medical site for the duration of the protocol."
Answered by AI
Is there currently an open call to join this trial?
"Affirmative. The clinicaltrials.gov portal attests that this research is in need of volunteers for its study, which was initially posted on June 5th 2020 and last updated September 9th 2022. Specifically, the project requires 100 individuals to join from 1 medical establishment."
Answered by AI
Who meets the criteria to participate in this research project?
"Prospective participants of this trial must have arthrosis and be between ages 18-45. The study's target enrollment is approximately 100 individuals."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
North Carolina
Other
Florida
How old are they?
65+
18 - 65
What site did they apply to?
Duke University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1
Why did patients apply to this trial?
To see if this could help me with choosing the right tree. Need to know what would work for me to perhaps lose weight and still remain healthy.
PatientReceived no prior treatments
Have trouble keeping weight off with solely lifestyle changes - tend to backslide into being sedentary very easily. Interested to see if medication is helpful in supporting weight loss efforts.
PatientReceived 2+ prior treatments
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