Functional DisabilityNCT00714506
Effects of a Weight Reduction and Lifestyle Program in Older Adults
A study testing Diet and physical activity in people with Functional Disability and Obesity, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Disability, Obesity, Physical Inactivity
- What is being tested?
- Diet and physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
McKeesport Hospital - Kelly Building
McKeesport, Pennsylvania, 15132
About this study
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.
- Conditions
- Functional Disability, Obesity, Physical Inactivity
- Being tested
- Diet and physical activity, Physical activity control
- Keywords
- obesity, physical activity, older adults, functional disability
- Medical subject headings
- Obesity, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet and physical activityBehavioural
lifestyle weight reduction - low fat eating, low calorie and physical activity
Physical activity controlOther
physical activity plus successful aging health education
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | lifestyle weight reduction - low fat eating, low calorie and physical activity Receives: Behavioral: Diet and physical activity |
| Control | Active comparator | physical activity plus successful aging health education Receives: Other: Physical activity control |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to walk 400 m
Measured: at 6 mo intervals
Secondary outcomes (1)
weight loss
Measured: 6 month intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Functional DisabilityStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne B. Newman, University of Pittsburgh
- Investigators
- Anne B Newman, MD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714506
- Sponsor's protocol ID
- PRO07040024
- Status last verified
- Jan 2016
- First submitted
- 9 Jul 2008
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
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 32003413Santanasto 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Weight Reduction and Lifestyle Program in Older Adults
- ClinicalTrials.gov ID
- NCT00714506
- Acronym / sponsor ID
- PRO07040024
- Conditions
- Functional Disability, Obesity, Physical Inactivity
- Keywords
- obesity, physical activity, older adults, functional disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2009 (actual)
- First posted
- 14 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Diet and physical activitylifestyle weight reduction - low fat eating, low calorie and physical activity |
| Control | Active comparator | Other: Physical activity controlphysical activity plus successful aging health education |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet and physical activitylifestyle weight reduction - low fat eating, low calorie and physical activity | Behavioural | Intervention |
| Physical activity controlphysical activity plus successful aging health education | Other | Control |
Primary outcome
time to walk 400 m
Time frame: at 6 mo intervals
1 secondary outcome
weight loss
Time frame: 6 month intervals
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
- Derived from this study: PubMed 32003413Farsijani 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.
- Derived from this study: PubMed 26482693Santanasto 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.
Related trials for Functional Disability
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Recruiting
Effect of Kendall Versus McKenzie Exercises in Patients With Upper Crossed Syndrome
Upper Crossed Syndrome
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Active, not recruiting
Effects of Subtalar Mobilization With and Without Foot Core Strengthening in Chronic Plantar Heel Pain
Chronic Plantar Heel Pain
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne B Newman, MD, MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and physical activity in people with Functional Disability and Obesity, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to walk 400 m (time frame: at 6 mo intervals). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00714506, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2016.