NCT00714506

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

1.8 years

First QC Date

July 9, 2008

Last Update Submit

January 12, 2016

Conditions

Functional DisabilityObesityPhysical Inactivity

Keywords

obesityphysical activityolder adultsfunctional disability

Outcome Measures

Primary Outcomes (1)

  • time to walk 400 m

    at 6 mo intervals

Secondary Outcomes (1)

  • weight loss

    6 month intervals

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Diet and physical activity

Control

ACTIVE COMPARATOR

physical activity plus successful aging health education

Other: Physical activity control

Interventions

Diet and physical activityBEHAVIORAL

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

Intervention
Physical activity controlOTHER

physical activity plus successful aging health education

Control

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McKeesport Hospital - Kelly Building

McKeesport, Pennsylvania, 15132, United States

Location

Related Publications (2)

  • 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.

    PMID: 32003413DERIVED

  • 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.

    PMID: 26482693DERIVED

MeSH Terms

Conditions

ObesitySedentary BehaviorMotor Activity

Interventions

DietExercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Anne B Newman, MD, MPH

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Epidemiology

Study Record Dates

First Submitted

July 9, 2008

First Posted

July 14, 2008

Study Start

March 1, 2008

Primary Completion

December 1, 2009

Last Updated

January 13, 2016

Record last verified: 2016-01

Locations

US(1)