Reducing Obesity and Cartilage Compression in Knees
- Conditions
- ObesityOsteoarthritisKnee Osteoarthritis
- Interventions
- Behavioral: Weight Loss
- Registration Number
- NCT04730557
- Lead Sponsor
- Duke University
- Brief Summary
OA is a degenerative joint disease that involves the degradation of articular cartilage and underlying subchondral bone. Obesity is identified as a critical and potentially modifiable risk factor for the development and progression of OA. The first objective of the study is to determine the effects of obesity on cartilage composition and function. The second objective of the study is to determine whether weight loss restores cartilage composition and function. Study activities would require getting MR Imaging, evaluation of joint loading using gait analysis techniques, cartilage strain measurement, and participating in weight loss intervention. The study will target a population age group between 18 and 45 years with a BMI greater than or equal to 29. Data analyses will be blinded to reduce potential bias. All subjects participating in this study will be informed of the risks involved and sign an IRB-approved consent form.
- Detailed Description
Appropriate study power will be achieved with 35 participants in the weight loss group and 35 participants in the weight maintenance control group (see Data Analysis and Statistical Considerations). We will recruit and enroll obese (BMI ≥29 - ≤40) men and women, age 18 to 45, with no previous history of lower extremity injury, no evidence of symptoms OA, no knee misalignment (neutral alignment between 178° and 182°), or other injury that would prevent them from performing the walking task required by this study. All inclusion criteria specific to knee injury, OA, and alignment will be verified by MRI scan. All participants in this study will be informed of the risks involved. Upon expressing interest in study participation, participants will be asked questions to determine whether they are free of lower extremity injury and their height and weight will also be recorded to determine their BMI. Potential participants will be pre-screened by phone using a phone script with a list of questions. Once it is determined they meet all study inclusion criteria, they will be invited to attend a consent meeting.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
- BMI (BMI ≥29 - <40)
- Age between 18 - 45
- History of lower extremity injury
- Evidence of symptoms of knee OA
- Knee misalignment
- Evidence of pregnancy
- Thigh unable to fit in MRI coil
- Body waist fit in MRI
- Have no metals in the body
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Weight-Loss Weight Loss 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.
- Primary Outcome Measures
Name Time Method Change from baseline in cartilage strain/thickness at 3 and 6 months Baseline, 3 months, and 6 months We will use MRI to detect change in cartilage strain/thickness at 3 and 6 months
- Secondary Outcome Measures
Name Time Method Change from baseline in cartilage composition at 3 and 6 months Baseline, 3 months, and 6 months We will use MRI to detect change in cartilage composition at 3 and 6 months
Change from baseline in inflammation at 3 and 6 months Baseline, 3 months, and 6 months Serum and urine biomarkers will be collected to determine levels of inflammation.
Change from baseline in cartilage degeneration at 3 and 6 months Baseline, 3 months, and 6 months We will use serum biomarkers to determine cartilage degeneration
Change from baseline in muscle strength at 3 and 6 months Baseline, 3 months, and 6 months Isokinetic dynamometer will be used to determine peak torque of knee extensor and flexor
Change in Healthy Eating Index at 3 months and 6 months Baseline, 3 months, and 6 months Healthy Eating Index (HEI-2015) calculated from Dietary History Questionnaire III (DHQIII, National Cancer Institute) at each time point. The HEI score ranges from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans..
Change from baseline in body weight at 3 and 6 months Baseline, 3 months, and 6 months Body weight as measured by Bodpod
Change from baseline in fat mass (%) at 3 and 6 months Baseline, 3 months, and 6 months Body fat mass (%) as measured by Bodpod
Change from baseline in lean mass (kg) at 3 and 6 months Baseline, 3 months, and 6 months Body lean mass (%) as measured by Bodpod
Change from baseline in umbilical waist circumference at 3 and 6 months Baseline, 3 months, and 6 months Body proportions will be measured at the umbilical waist using a Gulick II tape measure with the tape placed directly on the skin (not over clothes). Measurement will be taken once at each location before completing a second measurement, and an average of the two will be recorded. A third measurement will be taken if the first two measurements are \>0.5 cm.
Change in steps at 3 and 6 months Baseline, 3 months, and 6 months Steps will be determined using an actigraphy device worn for 7 days at each time point
Change from baseline in biomarkers of insulin resistance and beta-cell function at 3 and 6 months Baseline, 3 months, and 6 months We will use serum biomarkers to determine insulin resistance and beta-cell function
Change from baseline in lean mass (%) at 3 and 6 months Baseline, 3 months, and 6 months Body lean mass (%) as measured by Bodpod
Change from baseline macronutrients at 3 and 6 months Baseline, 3 months, and 6 months Total calories will be measured using a 3-day food record (participant records everything they eat and drink for three days)
Change from baseline in 6-minute walk (meters) at 3 and 6 months Baseline, 3 months, and 6 months Distanced (meters) walked in 6 minutes
Change from baseline in hip circumference at 3 and 6 months Baseline, 3 months, and 6 months Body proportions will be measured at the hip circumference using a Gulick II tape measure with the tape placed directly on the skin (not over clothes). Measurement will be taken once at each location before completing a second measurement, and an average of the two will be recorded. A third measurement will be taken if the first two measurements are \>0.5 cm.
Change in activity (intensity levels) at 3 and 6 months Baseline, 3 months, and 6 months Activity intensity levels using an actigraphy device worn for 7 days at each time point
Change from baseline in fat mass (kg) at 3 and 6 months Baseline, 3 months, and 6 months Body fat mass (kg) as measured by Bodpod
Change from baseline in minimal waist circumference at 3 and 6 months Baseline, 3 months, and 6 months Body proportions will be measured at the minimal waist using a Gulick II tape measure with the tape placed directly on the skin (not over clothes). Measurement will be taken once at each location before completing a second measurement, and an average of the two will be recorded. A third measurement will be taken if the first two measurements are \>0.5 cm.
Change from baseline total calories at 3 and 6 months Baseline, 3 months, and 6 months Total calories will be measured using a 3-day food record (participant records everything they eat and drink for three days)
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States