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

This study has been completed.
Sponsor:
Information provided by:
Wake Forest Baptist Health
ClinicalTrials.gov Identifier:
NCT00979043
First received: September 16, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Knee Osteoarthritis
Behavioral: Dietary Weight-loss
Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Arthritis, Diet, and Activity Promotion Trial

Resource links provided by NLM:


Further study details as provided by Wake Forest Baptist Health:

Primary Outcome Measures:
  • self-reported physical function (WOMAC scale) [ Time Frame: baseline, 6-months, 18-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 6-minute walking distance [ Time Frame: baseline, 6-months, 18-months ] [ Designated as safety issue: No ]
  • timed stair climbing [ Time Frame: baseline, 6-months, 18-months ] [ Designated as safety issue: No ]
  • weight-loss [ Time Frame: baseline, 6-months, 18-months ] [ Designated as safety issue: No ]
  • self-reported pain [ Time Frame: baseline, 6-months, 18-months ] [ Designated as safety issue: No ]
  • progression of knee osteoarthritis, measured radiographically [ Time Frame: baseline, 6-months, 18-months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • total mortality [ Time Frame: 7-9 yrs post-trial ] [ Designated as safety issue: No ]

Enrollment: 318
Study Start Date: November 1997
Study Completion Date: December 2000
Primary Completion Date: December 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Behavioral: 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.
Active Comparator: 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.
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.
Active Comparator: Dietary weight-loss & exercise
Participants received both the dietary weight-loss and exercise interventions for 18-months
Behavioral: 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.
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.
No Intervention: 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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979043

Locations
United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest Baptist Health
Investigators
Principal Investigator: Stephen P Messier, PhD Wake Forest School of Medicine
  More Information

Publications:
Responsible Party: Dr. Stephen Kritchevsky, Wake Forest Univ. Health Sciences
ClinicalTrials.gov Identifier: NCT00979043     History of Changes
Other Study ID Numbers: P60AG10484-07
Study First Received: September 16, 2009
Last Updated: September 16, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest Baptist Health:
knee osteoarthritis
weight-loss
exercise
obesity
physical function
total mortality

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014