Trial Summary
What is the purpose of this trial?The goal of this study is to establish the efficacy of an intervention of dietary weight loss, exercise, and weight-loss maintenance for knee Osteoarthritis (OA) prevention in adult females aged ≥ 50 years with obesity and no or infrequent knee pain. The primary aim is to compare the effects of a dietary weight loss, exercise, and weight-loss maintenance to an attention control group in preventing the development of structural Magnetic Resonance Imaging (MRI) knee OA. Secondary aims will determine the intervention effects on pain, mobility, health-related quality of life, knee joint compressive forces, inflammatory measures, weight loss, exercise self-efficacy, and cost-effectiveness of this intervention.
Is the treatment Diet and Exercise effective for preventing osteoarthritis?Yes, combining diet and exercise is a promising treatment for preventing osteoarthritis. It helps reduce pain, improve physical function, and decrease inflammation in overweight and obese individuals with knee osteoarthritis.49101213
What safety data exists for diet and exercise interventions for osteoarthritis prevention?The research provided does not directly address the safety of diet and exercise interventions specifically for osteoarthritis prevention. However, it discusses the effectiveness and potential health impacts of diet and exercise interventions for weight loss and obesity management. Some studies suggest that restrictive dieting can be hazardous, while others emphasize the importance of combining diet with exercise for better long-term outcomes. Overall, the safety of these interventions seems to depend on the specific dietary and exercise practices used, and the need for promoting healthy lifestyle changes rather than focusing solely on weight loss.123511
What data supports the idea that Diet and Exercise for Osteoarthritis Prevention is an effective treatment?The available research shows that combining diet and exercise can lead to significant improvements for people with knee osteoarthritis. One study found that older adults who followed a diet and exercise program lost weight and experienced less knee pain, improved walking ability, and better physical function compared to those who only exercised. Another study highlighted that patients who maintained weight loss through diet and exercise reported improvements in their symptoms over a year. Additionally, patients and dietitians in a weight loss program shared positive experiences, noting it as a highly beneficial change. These findings suggest that diet and exercise can be more effective than exercise alone or minimal intervention in managing osteoarthritis symptoms.467814
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. However, it focuses on diet and exercise, so it's best to discuss your medications with the trial coordinators.
Eligibility Criteria
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.Treatment Details
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.
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.
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of North Carolina at Chapel HillChapel Hill, NC
Brigham and Women's HospitalBoston, MA
Wake Forest UniversityWinston-Salem, NC
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Who is running the clinical trial?
Wake Forest UniversityLead Sponsor
Centers for Disease Control and PreventionCollaborator
University of Missouri-ColumbiaCollaborator
Arthritis FoundationCollaborator
National Center for Complementary and Integrative Health (NCCIH)Collaborator
Office of Research on Women's Health (ORWH)Collaborator
Office of Behavioral and Social Sciences Research (OBSSR)Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Collaborator
Office of Disease PreventionCollaborator
Rapid Nutrition PLCCollaborator
References
Exercise during and after very-low-calorie dieting. [2018]Neither diet nor exercise are effective as single modes of intervention in the treatment of obesity. Although it is logical that they be combined in the context of multidisciplinary treatment, restrictions in calorie or protein intakes while dieting may impair short-term or long-term function. The limited evidence available indicates that properly constituted very-low-calorie diets can effectively preserve physical function across major weight loss, but long-term preservation of this weight loss is strongly influenced by postdiet exercise habits. In summary, counseling on and initiation of safe and effective exercise practices during dietary treatment of obesity are appropriate, but the ultimate goal should be to direct the patient towards lifelong exercise behaviors that will contribute to sustained weight maintenance.
Effects of exercise-focused versus weight-focused maintenance programs on the management of obesity. [2019]This study examined the effects of two maintenance programs on exercise participation, energy expenditure, energy consumption, and weight change in 67 obese adults undergoing behavioral weight-loss treatment. Following an initial 6-month treatment phase which produced a mean weight loss of 8.8 kg, participants were assigned randomly to an exercise-focused maintenance program or to a weight-focused maintenance program. Both maintenance programs included 6 months of biweekly group sessions. The exercise-focused program included supervised group walking sessions, individual and group contingencies for exercise completion, and relapse prevention training targeted specifically at the maintenance of physical activity. The weight-focused program contained a general focus on the maintenance of weight-loss through therapist-led group problem-solving of weight-related problems presented by individual participants. At the completion of the maintenance program and at long-term follow-up, there were no significant differences between conditions in exercise participation or energy expenditure. However, during the year following initial treatment, participants in the weight-focused program demonstrated significantly greater reductions in fat consumption and significantly better maintenance of weight losses than subjects in the exercise-focused program.
How effective are traditional dietary and exercise interventions for weight loss? [2019]Health care professionals have used restrictive dieting and exercise intervention strategies in an effort to combat the rising prevalence of obesity in affluent countries. In spite of these efforts, the prevalence of obesity continues to rise. This apparent ineffectiveness of diet and exercise programming to reduce obesity has caused many health care providers, obesity researchers, and lay persons to challenge the further use of diet and exercise for the sole purpose of reducing body weight in the obese. The purposes of this paper were to examine the history and effectiveness of diet and exercise in obesity therapy and to determine the best future approach for health promotion in the obese population. A brief survey of the most popular dieting techniques used over the past 40 yr shows that most techniques cycle in and out of popularity and that many of these techniques may be hazardous to health. Data from the scientific community indicate that a 15-wk diet or diet plus exercise program produces a weight loss of about 11 kg with a 60-80% maintenance after 1 yr. Although long-term follow-up data are meager, the data that do exist suggest almost complete relapse after 3-5 yr. The paucity of data provided by the weight-loss industry has been inadequate or inconclusive. Those who challenge the use of diet and exercise solely for weight control purposes base their position on the absence of weight-loss effectiveness data and on the presence of harmful effects of restrictive dieting. Any intervention strategy for the obese should be one that would promote the development of a healthy lifestyle. The outcome parameters used to evaluate the success of such an intervention should be specific to chronic disease risk and symptomatologies and not limited to medically ambiguous variables like body weight or body composition.
Exercise and weight loss in obese older adults with knee osteoarthritis: a preliminary study. [2022]The purposes of this pilot study were to determine if a combined dietary and exercise intervention would result in significant weight loss in older obese adults with knee osteoarthritis, and to compare the effects of exercise plus dietary therapy with exercise alone on gait, strength, knee pain, biomarkers of cartilage degradation, and physical function.
Long-term effectiveness of diet-plus-exercise interventions vs. diet-only interventions for weight loss: a meta-analysis. [2009]Diet and exercise are two of the commonest strategies to reduce weight. Whether a diet-plus-exercise intervention is more effective for weight loss than a diet-only intervention in the long-term has not been conclusively established. The objective of this study was to systemically review the effect of diet-plus-exercise interventions vs. diet-only interventions on both long-term and short-term weight loss. Studies were retrieved by searching MEDLINE and Cochrane Library (1966 - June 2008). Studies were included if they were randomized controlled trials comparing the effect of diet-plus-exercise interventions vs. diet-only interventions on weight loss for a minimum of 6 months among obese or overweight adults. Eighteen studies met our inclusion criteria. Data were independently extracted by two investigators using a standardized protocol. We found that the overall standardized mean differences between diet-plus-exercise interventions and diet-only interventions at the end of follow-up were -0.25 (95% confidence interval [CI]-0.36 to -0.14), with a P-value for heterogeneity of 0.4. Because there were two outcome measurements, weight (kg) and body mass index (kg m(-2)), we also stratified the results by weight and body mass index outcome. The pooled weight loss was 1.14 kg (95% CI 0.21 to 2.07) or 0.50 kg m(-2) (95% CI 0.21 to 0.79) greater for the diet-plus-exercise group than the diet-only group. We did not detect significant heterogeneity in either stratum. Even in studies lasting 2 years or longer, diet-plus-exercise interventions provided significantly greater weight loss than diet-only interventions. In summary, a combined diet-plus-exercise programme provided greater long-term weight loss than a diet-only programme. However, both diet-only and diet-plus-exercise programmes are associated with partial weight regain, and future studies should explore better strategies to limit weight regain and achieve greater long-term weight loss.
The Intensive Diet and Exercise for Arthritis (IDEA) trial: design and rationale. [2021]Obesity is the most modifiable risk factor, and dietary induced weight loss potentially the best nonpharmacologic intervention to prevent or to slow osteoarthritis (OA) disease progression. We are currently conducting a study to test the hypothesis that intensive weight loss will reduce inflammation and joint loads sufficiently to alter disease progression, either with or without exercise. This article describes the intervention, the empirical evidence to support it, and test-retest reliability data.
Weight loss as treatment for knee osteoarthritis symptoms in obese patients: 1-year results from a randomised controlled trial. [2011]To evaluate 1-year symptomatic improvement in obese patients with knee osteoarthritis (OA) on an intensive low-energy diet (LED) maintained by frequent consultations with a dietician compared to minimal attention.
Effect of weight maintenance on symptoms of knee osteoarthritis in obese patients: a twelve-month randomized controlled trial. [2022]To compare results of obese patients with knee osteoarthritis (OA) who, after an intensive weight loss regimen, received 1 year of either dietary support (D), a knee-exercise program (E), or "no attention" (C; control group).
OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of lifestyle diet and exercise interventions for osteoarthritis. [2022]The objective was to develop a set of "best practices" for use as a primer for those interested in entering the clinical trials field for lifestyle diet and/or exercise interventions in osteoarthritis (OA), and as a set of recommendations for experienced clinical trials investigators. A subcommittee of the non-pharmacologic therapies committee of the OARSI Clinical Trials Working Group was selected by the Steering Committee to develop a set of recommended principles for non-pharmacologic diet/exercise OA randomized clinical trials. Topics were identified for inclusion by co-authors and reviewed by the subcommittee. Resources included authors' expert opinions, traditional search methods including MEDLINE (via PubMed), and previously published guidelines. Suggested steps and considerations for study methods (e.g., recruitment and enrollment of participants, study design, intervention and assessment methods) were recommended. The recommendations set forth in this paper provide a guide from which a research group can design a lifestyle diet/exercise randomized clinical trial in patients with OA.
Effect of physical activity and dietary restriction interventions on weight loss and the musculoskeletal function of overweight and obese older adults with knee osteoarthritis: a systematic review and mixed method data synthesis. [2022]Despite the clinical recommendation of exercise and diet for people with knee osteoarthritis (OA), there are no systematic reviews synthesising the effectiveness of combining physical activity and dietary restriction interventions on the musculoskeletal function of overweight and obese older adults with knee OA.
Effect, process, and economic evaluation of a combined resistance exercise and diet intervention (ProMuscle in Practice) for community-dwelling older adults: design and methods of a randomised controlled trial. [2023]Exercise and nutrition are important for older adults to maintain or to regain their muscle mass, function, strength, and ultimately quality of life. The effectiveness of combined resistance exercise and diet interventions is commonly evaluated in controlled clinical studies, but evidence from real-life settings is lacking. This article describes the effectiveness, process, and economic evaluation design of a combined nutrition and exercise intervention for community-dwelling older adults in a Dutch real-life setting.
Diet-induced weight loss alone or combined with exercise in overweight or obese people with knee osteoarthritis: A systematic review and meta-analysis. [2019]The purposes were to (i) determine the effect of diet-only treatments and combined diet and exercise treatments on pain and physical function and (ii) explore the effect of these treatments on inflammatory biomarkers in overweight and obese adults with knee osteoarthritis.
Inflammatory cytokines mediate the effects of diet and exercise on pain and function in knee osteoarthritis independent of BMI. [2020]Diet restriction and exercise form key treatments for osteoarthritis (OA) related symptoms in overweight and obese individuals. Although both interventions are known to influence systemic low-grade inflammation, which is related to pain levels and functional limitations, little is known about the potential changes in systemic inflammation as a working mechanism of diet restriction and exercise in knee OA.
"It's the single best thing I've done in the last 10 years": a qualitative study exploring patient and dietitian experiences with, and perceptions of, a multi-component dietary weight loss program for knee osteoarthritis. [2021]Explore patient and dietitian experiences with a multi-component dietary weight loss program for knee osteoarthritis to understand enablers and challenges to success at 6-months.