NCT00381290

Brief Summary

The purpose of this study is to compare the effects of a calorie-restricting diet, exercise, and a combination of both in reducing knee inflammation and compressive forces in obese and overweight adults with knee osteoarthritis (OA).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
454

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2006

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

November 6, 2017

Status Verified

September 1, 2011

Enrollment Period

4.7 years

First QC Date

September 25, 2006

Last Update Submit

November 2, 2017

Conditions

Osteoarthritis

Keywords

ArthritisArthritis, DegenerativeKnee HealthObesityOverweightOsteoarthritisWeight LossDietExerciseKnee Pain

Outcome Measures

Primary Outcomes (2)

  • Inflammatory biomarkers

    Measured at 0, 6, and 18 months (analyzed at 18 months)

  • Knee joint loads

    Measured at 0, 6, and 18 months

Secondary Outcomes (6)

  • Bone marrow lesions

    Measured at 0 and 18 months (analyzed at 18 months)

  • Articular cartilage

    Measured at 0 and 18 months (analyzed at 18 months)

  • Function

    Measured at 0, 6, and 18 months

  • Pain

    Measured at 0, 6, and 18 months

  • Mobility

    Measured at 0, 6, and 18 months

  • +1 more secondary outcomes

Study Arms (3)

1

ACTIVE COMPARATOR

Participants will follow an exercise regimen

Behavioral: Exercise

2

ACTIVE COMPARATOR

Participants will follow a calorie-restricted diet

Behavioral: Diet

3

ACTIVE COMPARATOR

Participants will follow a calorie-restricted diet and an exercise regimen

Behavioral: DietBehavioral: Exercise

Interventions

DietBEHAVIORAL

The prescribed diet will include traditional healthy food and up to two meal replacement supplements. Initially, the diet will be set to result in an overall loss of 800 to 1000 calories per day.

23
ExerciseBEHAVIORAL

The program will consist of 60-minute exercise sessions per week for the duration of the study. The exercise sessions will incorporate aerobic exercise and resistance training. Participants will also be encouraged to exercise at home.

13

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Grade II to III radiographic tibiofemoral OA of one or both knees
  • Body mass index (BMI) of 27 to 37
  • Sedentary lifestyle, defined as not participating in more than 30 minutes of formal exercise per week within the 6 months prior to study entry

You may not qualify if:

  • Significant comorbidity that may pose a safety risk to the participant or otherwise interfere with the study. More information about this criterion can be found in the protocol.
  • Previous acute knee injury
  • Knee injection within 1 month of study entry
  • Knee surgery within 6 months of study entry
  • Knee OA other than tibiofemoral OA
  • Unwilling or unable to change eating and physical activity habits due to environment
  • Cannot speak or read English
  • Excess alcohol use (21 or more drinks per week)
  • Unable to finish the 18-month study or unlikely to comply with the study
  • Unable to undergo MRI of the knee
  • Significant cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University/Wake Forest University Forest School of Medicine

Winston-Salem, North Carolina, 27109, United States

Location

Related Publications (14)

  • Focht BC, Rejeski WJ, Ambrosius WT, Katula JA, Messier SP. Exercise, self-efficacy, and mobility performance in overweight and obese older adults with knee osteoarthritis. Arthritis Rheum. 2005 Oct 15;53(5):659-65. doi: 10.1002/art.21466.

    PMID: 16208674BACKGROUND

  • Messier SP, Gutekunst DJ, Davis C, DeVita P. Weight loss reduces knee-joint loads in overweight and obese older adults with knee osteoarthritis. Arthritis Rheum. 2005 Jul;52(7):2026-32. doi: 10.1002/art.21139.

    PMID: 15986358BACKGROUND

  • Messier SP, Loeser RF, Miller GD, Morgan TM, Rejeski WJ, Sevick MA, Ettinger WH Jr, Pahor M, Williamson JD. Exercise and dietary weight loss in overweight and obese older adults with knee osteoarthritis: the Arthritis, Diet, and Activity Promotion Trial. Arthritis Rheum. 2004 May;50(5):1501-10. doi: 10.1002/art.20256.

    PMID: 15146420BACKGROUND

  • Welhaven HD, Welfley AH, Bothner B, Messier SP, Loeser RF, June RK. The metabolome of male and female individuals with knee osteoarthritis is influenced by 18-months of weight loss intervention: the IDEA trial. BMC Musculoskelet Disord. 2024 Dec 20;25(1):1057. doi: 10.1186/s12891-024-08166-7.

    PMID: 39707277DERIVED

  • Munugoda IP, Beavers DP, Wirth W, Aitken DA, Loeser RF, Miller GD, Lyles M, Carr JJ, Guermazi A, Hunter DJ, Messier SP, Eckstein F. The effect of weight loss on the progression of meniscal extrusion and size in knee osteoarthritis: a post-hoc analysis of the Intensive Diet and Exercise for Arthritis (IDEA) trial. Osteoarthritis Cartilage. 2020 Apr;28(4):410-417. doi: 10.1016/j.joca.2020.01.006. Epub 2020 Jan 31.

    PMID: 32014493DERIVED

  • Messier SP, Resnik AE, Beavers DP, Mihalko SL, Miller GD, Nicklas BJ, deVita P, Hunter DJ, Lyles MF, Eckstein F, Guermazi A, Loeser RF. Intentional Weight Loss in Overweight and Obese Patients With Knee Osteoarthritis: Is More Better? Arthritis Care Res (Hoboken). 2018 Nov;70(11):1569-1575. doi: 10.1002/acr.23608.

    PMID: 29911741DERIVED

  • Mihalko SL, Cox P, Beavers DP, Miller GD, Nicklas BJ, Lyles M, Hunter DJ, Eckstein F, Guermazi A, Loeser RF, DeVita P, Messier SP. Effect of intensive diet and exercise on self-efficacy in overweight and obese adults with knee osteoarthritis: The IDEA randomized clinical trial. Transl Behav Med. 2019 Mar 1;9(2):227-235. doi: 10.1093/tbm/iby037.

    PMID: 29635402DERIVED

  • Loeser RF, Beavers DP, Bay-Jensen AC, Karsdal MA, Nicklas BJ, Guermazi A, Hunter DJ, Messier SP. Effects of dietary weight loss with and without exercise on interstitial matrix turnover and tissue inflammation biomarkers in adults with knee osteoarthritis: the Intensive Diet and Exercise for Arthritis trial (IDEA). Osteoarthritis Cartilage. 2017 Nov;25(11):1822-1828. doi: 10.1016/j.joca.2017.07.015. Epub 2017 Jul 27.

    PMID: 28756278DERIVED

  • Beavers KM, Beavers DP, Newman JJ, Anderson AM, Loeser RF Jr, Nicklas BJ, Lyles MF, Miller GD, Mihalko SL, Messier SP. Effects of total and regional fat loss on plasma CRP and IL-6 in overweight and obese, older adults with knee osteoarthritis. Osteoarthritis Cartilage. 2015 Feb;23(2):249-56. doi: 10.1016/j.joca.2014.11.005. Epub 2014 Nov 13.

    PMID: 25450847DERIVED

  • Messier SP, Beavers DP, Loeser RF, Carr JJ, Khajanchi S, Legault C, Nicklas BJ, Hunter DJ, Devita P. Knee joint loading in knee osteoarthritis: influence of abdominal and thigh fat. Med Sci Sports Exerc. 2014 Sep;46(9):1677-83. doi: 10.1249/MSS.0000000000000293.

    PMID: 25133996DERIVED

  • Beavers DP, Beavers KM, Loeser RF, Walton NR, Lyles MF, Nicklas BJ, Shapses SA, Newman JJ, Messier SP. The independent and combined effects of intensive weight loss and exercise training on bone mineral density in overweight and obese older adults with osteoarthritis. Osteoarthritis Cartilage. 2014 Jun;22(6):726-33. doi: 10.1016/j.joca.2014.04.002. Epub 2014 Apr 15.

    PMID: 24742955DERIVED

  • Messier SP, Mihalko SL, Legault C, Miller GD, Nicklas BJ, DeVita P, Beavers DP, Hunter DJ, Lyles MF, Eckstein F, Williamson JD, Carr JJ, Guermazi A, Loeser RF. Effects of intensive diet and exercise on knee joint loads, inflammation, and clinical outcomes among overweight and obese adults with knee osteoarthritis: the IDEA randomized clinical trial. JAMA. 2013 Sep 25;310(12):1263-73. doi: 10.1001/jama.2013.277669.

    PMID: 24065013DERIVED

  • Chmelo E, Nicklas B, Davis C, Miller GD, Legault C, Messier S. Physical activity and physical function in older adults with knee osteoarthritis. J Phys Act Health. 2013 Aug;10(6):777-83. doi: 10.1123/jpah.10.6.777. Epub 2012 Oct 9.

    PMID: 23307503DERIVED

  • Messier SP, Legault C, Mihalko S, Miller GD, Loeser RF, DeVita P, Lyles M, Eckstein F, Hunter DJ, Williamson JD, Nicklas BJ. The Intensive Diet and Exercise for Arthritis (IDEA) trial: design and rationale. BMC Musculoskelet Disord. 2009 Jul 28;10:93. doi: 10.1186/1471-2474-10-93.

    PMID: 19638215DERIVED

MeSH Terms

Conditions

OsteoarthritisArthritisObesityOverweightWeight LossMotor Activity

Interventions

DietExercise

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Stephen P. Messier, PhD

    Wake Forest University, Department of Health and Exercise Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2006

First Posted

September 27, 2006

Study Start

October 1, 2006

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

November 6, 2017

Record last verified: 2011-09

Locations

US(1)