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CompletedNCT00714506Updated Jan 13, 2016

Effects of a Weight Reduction and Lifestyle Program in Older Adults

An interventional study of Diet and physical activity and Physical activity control in Functional Disability, Obesity and Physical Inactivity, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 65 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-13.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
65 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Functional Disability
  • Obesity
  • Physical Inactivity

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Keywords

  • obesity
  • physical activity
  • older adults
  • functional disability
03

In context

Weight Loss

1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.

This study's enrollment of 36 is below the median of 73 across 1,496 interventional studies indexed under Weight Loss.

Browse Weight Loss studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Intervention

    lifestyle weight reduction - low fat eating, low calorie and physical activity

    Behavioral: Diet and physical activity

  • Active comparator
    Control

    physical activity plus successful aging health education

    Other: Physical activity control

Interventions

  • BehavioralDiet and physical activity

    lifestyle weight reduction - low fat eating, low calorie and physical activity

  • OtherPhysical activity control

    physical activity plus successful aging health education

06

What researchers measure

Primary outcomes

  1. time to walk 400 m

    Time frame: at 6 mo intervals

Secondary outcomes

  1. weight loss

    Time frame: 6 month intervals

07

Study locations

1 site
  • McKeesport Hospital - Kelly Building
    McKeesport, Pennsylvania 15132, United States
08

References and documents

Publications

  • 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. PubMed 32003413 ↗
  • 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. PubMed 26482693 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00714506
Lead sponsor
University of Pittsburgh
Responsible party
Anne B. Newman (Professor of Epidemiology, University of Pittsburgh) — Principal investigator
First posted
Jul 14, 2008
Start date
Mar 2008
Primary completion
Dec 2009
Last update
Jan 13, 2016

Study contacts

Anne B Newman, MD, MPH
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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