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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

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Structural knee Osteoarthritis (OA) MRI change Scores

Secondary study objectives

Health-Related Quality of Life Scores

Knee Pain Scores

Mobility Scores

Other study objectives

Cost-Effectiveness Ratios

Inflammation Value

Knee Joint Loading Number

+2 more

Side effects data

From 2019 Phase 2 trial • 22 Patients • NCT01792115

43%

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%

Study treatment Arm

Vit E 200 IU/d

Vitamin E 400

Vitamin E 800

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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