Effects of a Weight Reduction and Lifestyle Program in Older Adults
Primary Purpose
Functional Disability, Obesity, Physical Inactivity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet and physical activity
Physical activity control
Sponsored by
About this trial
This is an interventional prevention trial for Functional Disability focused on measuring obesity, physical activity, older adults, functional disability
Eligibility 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.
Sites / Locations
- McKeesport Hospital - Kelly Building
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
lifestyle weight reduction - low fat eating, low calorie and physical activity
physical activity plus successful aging health education
Outcomes
Primary Outcome Measures
time to walk 400 m
Secondary Outcome Measures
weight loss
Full Information
NCT ID
NCT00714506
First Posted
July 9, 2008
Last Updated
January 12, 2016
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT00714506
Brief Title
Effects of a Weight Reduction and Lifestyle Program in Older Adults
Official Title
Effects of a Weight Reduction and Lifestyle Program in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Disability, Obesity, Physical Inactivity
Keywords
obesity, physical activity, older adults, functional disability
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
lifestyle weight reduction - low fat eating, low calorie and physical activity
Arm Title
Control
Arm Type
Active Comparator
Arm Description
physical activity plus successful aging health education
Intervention Type
Behavioral
Intervention Name(s)
Diet and physical activity
Intervention Description
lifestyle weight reduction - low fat eating, low calorie and physical activity
Intervention Type
Other
Intervention Name(s)
Physical activity control
Intervention Description
physical activity plus successful aging health education
Primary Outcome Measure Information:
Title
time to walk 400 m
Time Frame
at 6 mo intervals
Secondary Outcome Measure Information:
Title
weight loss
Time Frame
6 month intervals
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne B Newman, MD, MPH
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
McKeesport Hospital - Kelly Building
City
McKeesport
State/Province
Pennsylvania
ZIP/Postal Code
15132
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32003413
Citation
Farsijani S, Cauley JA, Santanasto AJ, Glynn NW, Boudreau RM, Newman AB. Transition to a More even Distribution of Daily Protein intake Is Associated with Enhanced Fat Loss during a Hypocaloric and Physical Activity Intervention in Obese Older Adults. J Nutr Health Aging. 2020;24(2):210-217. doi: 10.1007/s12603-020-1313-8.
Results Reference
derived
PubMed Identifier
26482693
Citation
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.
Results Reference
derived
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Effects of a Weight Reduction and Lifestyle Program in Older Adults
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