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

Wake Forest University (WFU)

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Behavioral: Exercise; Behavioral: Dietary Weight-loss

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00979043

IRB00003799

P60AG010484-07 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 318 patients

Sex: All

Ages: 60+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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318 participants in 4 patient groups

Dietary weight-loss

Active Comparator group

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.

Treatment:

Behavioral: Dietary Weight-loss

Exercise

Active Comparator group

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.

Treatment:

Behavioral: Exercise

Dietary weight-loss & exercise

Active Comparator group

Description:

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

Treatment:

Behavioral: Dietary Weight-loss

Behavioral: Exercise

Health lifestyle control

No Intervention group

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.