Clinical trial NCT00714506: 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
Overall status: COMPLETED
Phase: NA
Conditions: Functional Disability
Obesity
Physical Inactivity
Keywords: obesity
physical activity
older adults
functional disability
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2008-07-14
Enrollment: 36
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: time to walk 400 m
timeFrame: at 6 mo intervals
Secondary outcomes:
measure: weight loss
timeFrame: 6 month intervals
Other outcomes:
Locations:
city: McKeesport
country: United States
facility: McKeesport Hospital - Kelly Building
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Anne B Newman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.