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Effects of a Weight Reduction and Lifestyle Program in Older Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00714506
First Posted: July 14, 2008
Last Update Posted: January 13, 2016
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.
Information provided by (Responsible Party):
Anne B. Newman, University of Pittsburgh
  Purpose
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.

Condition Intervention
Functional Disability Obesity Physical Inactivity Behavioral: Diet and physical activity Other: Physical activity control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of a Weight Reduction and Lifestyle Program in Older Adults

Resource links provided by NLM:


Further study details as provided by Anne B. Newman, University of Pittsburgh:

Primary Outcome Measures:
  • time to walk 400 m [ Time Frame: at 6 mo intervals ]

Secondary Outcome Measures:
  • weight loss [ Time Frame: 6 month intervals ]

Enrollment: 36
Study Start Date: March 2008
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
lifestyle weight reduction - low fat eating, low calorie and physical activity
Behavioral: Diet and physical activity
lifestyle weight reduction - low fat eating, low calorie and physical activity
Active Comparator: Control
physical activity plus successful aging health education
Other: Physical activity control
physical activity plus successful aging health education

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00714506


Locations
United States, Pennsylvania
McKeesport Hospital - Kelly Building
McKeesport, Pennsylvania, United States, 15132
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Anne B Newman, MD, MPH University of Pittsburgh
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne B. Newman, Professor of Epidemiology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00714506     History of Changes
Other Study ID Numbers: PRO07040024
First Submitted: July 9, 2008
First Posted: July 14, 2008
Last Update Posted: January 13, 2016
Last Verified: January 2016

Keywords provided by Anne B. Newman, University of Pittsburgh:
obesity
physical activity
older adults
functional disability

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms