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Effects of a Weight Reduction and Lifestyle Program in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00714506
Recruitment Status : Completed
First Posted : July 14, 2008
Last Update Posted : January 13, 2016
Information provided by (Responsible Party):

July 9, 2008
July 14, 2008
January 13, 2016
March 2008
December 2009   (Final data collection date for primary outcome measure)
time to walk 400 m [ Time Frame: at 6 mo intervals ]
Same as current
Complete list of historical versions of study NCT00714506 on ClinicalTrials.gov Archive Site
weight loss [ Time Frame: 6 month intervals ]
Same as current
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Effects of a Weight Reduction and Lifestyle Program in Older Adults
Effects of a Weight Reduction and Lifestyle Program in Older Adults
This research study will assess the effects of two different programs on weight, body composition, mobility and improved health. Measures of health will include functional abilities, and physical performance. The 2 programs being tested will be provided the same physical activity program which will include aerobic activity and resistance (weight) training. The intervention study will last up to 1 year with follow-up at 6 months and yearly phone calls thereafter.
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Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
  • Functional Disability
  • Obesity
  • Physical Inactivity
  • Behavioral: Diet and physical activity
    lifestyle weight reduction - low fat eating, low calorie and physical activity
  • Other: Physical activity control
    physical activity plus successful aging health education
  • Experimental: Intervention
    lifestyle weight reduction - low fat eating, low calorie and physical activity
    Intervention: Behavioral: Diet and physical activity
  • Active Comparator: Control
    physical activity plus successful aging health education
    Intervention: Other: Physical activity control
Santanasto AJ, Newman AB, Strotmeyer ES, Boudreau RM, Goodpaster BH, Glynn NW. Effects of Changes in Regional Body Composition on Physical Function in Older Adults: A Pilot Randomized Controlled Trial. J Nutr Health Aging. 2015 Nov;19(9):913-21. doi: 10.1007/s12603-015-0523-y.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Not Provided
December 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 65 and older
  • BMI 28 to 39.9
  • Sedentary lifestyle defined by formal exercise less than 3 times per week for a total of less than 90 minutes.
  • Self report of ability to walk ¼ mile (2-3 blocks)
  • Ability to complete the 400 meter walk without a cane or walker in less than 15 minutes
  • Successful completion of the behavioral run-in phase which includes an activity log and a food diary
  • Willingness to be randomized to either intervention group
  • Willingness to attend meetings and physical activity sessions in McKeesport

Exclusion Criteria:

  • Diabetes requiring insulin, history of diabetic coma, or diabetes out of control defined as fasting blood sugar greater than 300
  • Severe hypertension, e.g. SBP> 180, DBP > 100
  • Failure to provide informed consent
  • Nursing home resident or resident in a facility where they have no control over food choices
  • Significant cognitive impairment, defined as a known diagnosis of dementia or a 3MSE Cognitive Function score < 80
  • Major psychiatric disorder
  • Unable to communicate because of severe hearing loss or speech disorder
  • Severe visual impairment
  • Celiac sprue or other malabsorption syndromes
  • Consume more than 5 alcoholic drinks per day, or more than 15 drinks per week
  • Progressive, degenerative neurological disease
  • Severe rheumatologic or orthopedic diseases
  • Stroke, hip, or knee replacement, or spinal surgery within the past 4 months or planned in the next 4 months
  • Receiving physical therapy for gait, balance, or lower extremity training
  • Terminal illness with life expectancy of less than 12 months
  • Currently being treated with chemotherapy or radiation for breast, cervical, colon, prostate, rectal, uterine, thyroid, or oral cancer. Participant with other types of cancers, with the exception of basal and squamous cancer are ineligible
  • Severe pulmonary disease (i.e., lung disease requiring supplemental oxygen or oral steroid medication) or pulmonary embolism or deep vein thrombosis within the past 6 months
  • Severe cardiac disease (i.e., congestive heart failure (NYHA Class III or IV); untreated aortic stenosis; a history of cardiac arrest, the use of a cardiac defibrillator or uncontrolled angina)
  • Myocardial infarction, CABG, or valve replacement in the past 6 months
  • Serious conduction disorder (3rd degree heart block), uncontrolled arrhythmia, or new Q waves or ST- segment depressions (> 3mm) on ECG
  • Other significant co-morbid disease that the study medical officer deems severe enough to impair ability to participate in exercise based intervention
  • Severe kidney disease that requires dialysis
  • Develops chest pain or severe shortness of breath during 400 m walk test
  • Member of household is already enrolled
  • Participation in another intervention trial: participation in an observational study is permitted
  • People who have lost more than 10 pounds in the past 4 months, or are on any drugs for the treatment of obesity
  • Lives outside of the study site area or is planning to move in the next year
  • Must be able to attend at least 6 of the first 8 weekly sessions.
Sexes Eligible for Study: All
65 Years to 100 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Anne B. Newman, University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Anne B Newman, MD, MPH University of Pittsburgh
University of Pittsburgh
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP