The Arthritis, Diet, and Activity Promotion Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

318 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-11-30

Study Completion Date

2000-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Dietary weight-loss

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.

Group Type ACTIVE_COMPARATOR

Dietary Weight-loss

Intervention Type BEHAVIORAL

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.

Exercise

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.

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type BEHAVIORAL

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.

Dietary weight-loss & exercise

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

Group Type ACTIVE_COMPARATOR

Dietary Weight-loss

Intervention Type BEHAVIORAL

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.

Exercise

Intervention Type BEHAVIORAL

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.

Health lifestyle control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dietary Weight-loss

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

Exercise

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No