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The Arthritis, Diet, and Activity Promotion Trial (ADAPT)

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Weight-loss
Exercise
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, weight-loss, exercise, obesity, physical function, total mortality

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 60 years.
  • BMI ≥ 28 kg/m2.
  • Knee pain on most days of the month.
  • Sedentary lifestyle pattern (<20 min exercise per week for last 6 months)
  • Self-reported difficulty with at least one of the following: walking 1/4 mile, climbing stairs, kneeling, bending, stooping, shopping, lifting, self-care.
  • Radiographic evidence of grade 1-3 knee osteoarthritis.

Exclusion Criteria:

  • Serious medical condition that precludes safe participation in exercise such as heart disease (angina, congestive heart failure), severe hypertension, COPD, renal or liver disease, insulin-dependent diabetes.
  • Mini-mental state exam score <24.
  • Inability to walks without a cane.
  • Reported alcohol consumption >14 drinks/week.
  • Inability to complete protocol.
  • ST segment depression.
  • Participation in another research study.

Sites / Locations

  • Wake Forest University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

Dietary weight-loss

Exercise

Dietary weight-loss & exercise

Health lifestyle control

Arm Description

The goal of the dietary weight-loss intervention was to produce and maintain a mean weight-loss of 5% initial body weight during the 18-month intervention, using dietary counseling and behavior modification.

Participants participated in resistance training (15 minutes) and aerobic exercise (30 minutes) 3d/week for 18-months. The first 4-months of the exercise training were facility-based. After 4-months, participants were allowed to transition to a home-based intervention if they chose to.

Participants received both the dietary weight-loss and exercise interventions for 18-months

The healthy-lifestyle control served as the usual care comparison group. For 3 months, participants met monthly with a health educator to discuss topics such as osteoarthritis, obesity, and exercise. Regular phone contact was maintained during months 4-18.

Outcomes

Primary Outcome Measures

self-reported physical function (WOMAC scale)

Secondary Outcome Measures

6-minute walking distance
timed stair climbing
weight-loss
self-reported pain
progression of knee osteoarthritis, measured radiographically
chronic inflammation, measured according to CRP, IL-6, IL-6 soluble receptor, TNF-alpha, TNF alpha receptors 1 and 2
total mortality

Full Information

First Posted
September 16, 2009
Last Updated
April 12, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00979043
Brief Title
The Arthritis, Diet, and Activity Promotion Trial
Acronym
ADAPT
Official Title
The Arthritis, Diet, and Activity Promotion Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 1997 (undefined)
Primary Completion Date
December 2000 (Actual)
Study Completion Date
December 2000 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose of this study was to determine the effect of dietary weight-loss, exercise training, or a combination of both on physical function in overweight and obese adults with knee osteoarthritis (OA). In secondary analyses, the effect of weight-loss and/or exercise on OA progression, self-reported pain and inflammation were examined. In post-trial analyses, the effect of dietary weight-loss on total mortality was determined.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, weight-loss, exercise, obesity, physical function, total mortality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
318 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary weight-loss
Arm Type
Active Comparator
Arm Description
The goal of the dietary weight-loss intervention was to produce and maintain a mean weight-loss of 5% initial body weight during the 18-month intervention, using dietary counseling and behavior modification.
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
Participants participated in resistance training (15 minutes) and aerobic exercise (30 minutes) 3d/week for 18-months. The first 4-months of the exercise training were facility-based. After 4-months, participants were allowed to transition to a home-based intervention if they chose to.
Arm Title
Dietary weight-loss & exercise
Arm Type
Active Comparator
Arm Description
Participants received both the dietary weight-loss and exercise interventions for 18-months
Arm Title
Health lifestyle control
Arm Type
No Intervention
Arm Description
The healthy-lifestyle control served as the usual care comparison group. For 3 months, participants met monthly with a health educator to discuss topics such as osteoarthritis, obesity, and exercise. Regular phone contact was maintained during months 4-18.
Intervention Type
Behavioral
Intervention Name(s)
Dietary Weight-loss
Intervention Description
The goal of the dietary weight-loss intervention was to produce and maintain a mean weight-loss of 5% initial body weight during the 18-month intervention, using dietary counseling and behavior modification.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Participants participated in resistance training (15 minutes) and aerobic exercise (30 minutes) 3d/week for 18-months. The first 4-months of the exercise training were facility-based. After 4-months, participants were allowed to transition to a home-based intervention if they chose to.
Primary Outcome Measure Information:
Title
self-reported physical function (WOMAC scale)
Time Frame
baseline, 6-months, 18-months
Secondary Outcome Measure Information:
Title
6-minute walking distance
Time Frame
baseline, 6-months, 18-months
Title
timed stair climbing
Time Frame
baseline, 6-months, 18-months
Title
weight-loss
Time Frame
baseline, 6-months, 18-months
Title
self-reported pain
Time Frame
baseline, 6-months, 18-months
Title
progression of knee osteoarthritis, measured radiographically
Time Frame
baseline, 6-months, 18-months
Title
chronic inflammation, measured according to CRP, IL-6, IL-6 soluble receptor, TNF-alpha, TNF alpha receptors 1 and 2
Time Frame
baseline and 18-months
Title
total mortality
Time Frame
7-9 yrs post-trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 60 years. BMI ≥ 28 kg/m2. Knee pain on most days of the month. Sedentary lifestyle pattern (<20 min exercise per week for last 6 months) Self-reported difficulty with at least one of the following: walking 1/4 mile, climbing stairs, kneeling, bending, stooping, shopping, lifting, self-care. Radiographic evidence of grade 1-3 knee osteoarthritis. Exclusion Criteria: Serious medical condition that precludes safe participation in exercise such as heart disease (angina, congestive heart failure), severe hypertension, COPD, renal or liver disease, insulin-dependent diabetes. Mini-mental state exam score <24. Inability to walks without a cane. Reported alcohol consumption >14 drinks/week. Inability to complete protocol. ST segment depression. Participation in another research study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen P Messier, PhD
Organizational Affiliation
Wake Forest University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15146420
Citation
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.
Results Reference
result
PubMed Identifier
15051595
Citation
Nicklas BJ, Ambrosius W, Messier SP, Miller GD, Penninx BW, Loeser RF, Palla S, Bleecker E, Pahor M. Diet-induced weight loss, exercise, and chronic inflammation in older, obese adults: a randomized controlled clinical trial. Am J Clin Nutr. 2004 Apr;79(4):544-51. doi: 10.1093/ajcn/79.4.544.
Results Reference
result
PubMed Identifier
15278105
Citation
Miller GD, Nicklas BJ, Davis CC, Ambrosius WT, Loeser RF, Messier SP. Is serum leptin related to physical function and is it modifiable through weight loss and exercise in older adults with knee osteoarthritis? Int J Obes Relat Metab Disord. 2004 Nov;28(11):1383-90. doi: 10.1038/sj.ijo.0802737.
Results Reference
result
PubMed Identifier
18359648
Citation
Chua SD Jr, Messier SP, Legault C, Lenz ME, Thonar EJ, Loeser RF. Effect of an exercise and dietary intervention on serum biomarkers in overweight and obese adults with osteoarthritis of the knee. Osteoarthritis Cartilage. 2008 Sep;16(9):1047-53. doi: 10.1016/j.joca.2008.02.002. Epub 2008 Mar 24.
Results Reference
result

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The Arthritis, Diet, and Activity Promotion Trial

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