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Behavioral Intervention
Diet and Exercise for Osteoarthritis Prevention (TOPS Trial)
N/A
Recruiting
Led By Stephen P Messier, Ph.D.
Research Sponsored by Wake Forest University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 48
Awards & highlights
TOPS Trial Summary
This trial will test if a diet, exercise and weight loss plan can help prevent knee OA in overweight and obese women over 50 with little to no knee pain.
Who is the study for?
This trial is for women over 50 with obesity who have no or rare knee pain and no signs of knee osteoarthritis on X-rays or MRI. They must not be using walking aids, have a BMI ≥ 30 kg/m2, and can't be undergoing cancer treatment, have type 1 diabetes, severe heart issues, recent major knee injuries or surgeries.Check my eligibility
What is being tested?
The study tests if dieting to lose weight combined with exercise can prevent knee osteoarthritis in at-risk women. Participants will either follow this program or join an attention control group. The effects on their knees will be monitored through MRIs and other health measures.See study design
What are the potential side effects?
Potential side effects may include muscle soreness from exercise and changes in digestion due to new diets. However, since the interventions are non-drug based (dietary change and physical activity), serious side effects are less likely compared to medication trials.
TOPS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Structural knee Osteoarthritis (OA) MRI change Scores
Secondary outcome measures
Health-Related Quality of Life Scores
Knee Pain Scores
Mobility Scores
Other outcome measures
Cost-Effectiveness Ratios
Inflammation Value
Knee Joint Loading Number
+2 moreSide effects data
From 2019 Phase 2 trial • 22 Patients • NCT0179211543%
Iron deficiency or anemia
29%
Hypokalemia
14%
Viral gastroenteritis
14%
Galactorrhea
14%
Breast cancer
14%
Hypertensive crisis
14%
Hypertensive crisis (medication non-compliance)
14%
Headache/Migraine
14%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vit E 200 IU/d
Vitamin E 400
Vitamin E 800
TOPS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Diet and ExerciseExperimental Treatment1 Intervention
The dietary component of the weight loss intervention is characterized by the frequency of contacts, methods to induce dietary restriction, and behavioral therapy strategies. The first 6 months of the diet program is an energy-restricted diet with the option of using partial meal replacements and nutritious snacks (Rapid Nutrition, PLC). The weight loss goal for the diet and exercise group is a minimum of 10% of baseline body weight by the end of year 1. The weight loss phase is followed by 3 years of a weight-loss maintenance program, with the goal of sustaining the achieved weight loss. The exercise component includes 60-minute sessions 2 days per week for 48 months.
Group II: Attention ControlActive Control1 Intervention
This comparison group provides attention, social interaction, and healthy lifestyle classes. There will be 4, 1-hour face-to-face group meetings per year featuring community health professionals, quarterly newsletters, and quarterly text messages.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diet and Exercise
2017
Completed Phase 4
~1940
Find a Location
Who is running the clinical trial?
Centers for Disease Control and PreventionFED
875 Previous Clinical Trials
22,476,172 Total Patients Enrolled
8 Trials studying Osteoarthritis
3,443 Patients Enrolled for Osteoarthritis
University of Missouri-ColumbiaOTHER
362 Previous Clinical Trials
626,884 Total Patients Enrolled
11 Trials studying Osteoarthritis
11,600 Patients Enrolled for Osteoarthritis
Wake Forest UniversityLead Sponsor
190 Previous Clinical Trials
163,370 Total Patients Enrolled
4 Trials studying Osteoarthritis
1,670 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience pain in both knees for more than 15 days each month.I am currently receiving treatment for cancer.I have Type 1 diabetes.I am female.I plan to stay in the area for the next 4 years without leaving for more than 2 months.My knee does not show arthritis on X-ray or MRI.I rarely have knee pain, less than 15 days a month.I am male.I need a device to walk.My knee arthritis is confirmed by X-ray to be moderate or severe.I have osteoarthritis in both knees confirmed by MRI.I have had a knee injection in the last 6 months.In the last year, I've had a knee injury or surgery for ACL, MCL, or meniscus.I have severe heart disease symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Attention Control
- Group 2: Diet and Exercise
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are medical professionals currently recruiting participants for this clinical trial?
"Unfortunately, this clinical trial is no longer actively recruiting patients at the present moment. According to its entry on clinicaltrials.gov, it was first posted July 1st 2023 and last updated July 6th 2023. However, there are still 693 other trials that require participants right now."
Answered by AI
Are there a diversity of facilities involved in the conductance of this experiment within city limits?
"Currently, the 4 sites recruiting participants are located in Chapel Hill, Winston-Salem and Sydney. In order to ease travel concerns for enrollees, it is recommended that they select a location nearest them. Additionally there are other recruitment centres available too."
Answered by AI
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