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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014