- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00714506
Effects of a Weight Reduction and Lifestyle Program in Older Adults
12. januar 2016 opdateret af: Anne B. Newman, University of Pittsburgh
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
36
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Pennsylvania
-
McKeesport, Pennsylvania, Forenede Stater, 15132
- McKeesport Hospital - Kelly Building
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
65 år til 100 år (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention
lifestyle weight reduction - low fat eating, low calorie and physical activity
|
lifestyle weight reduction - low fat eating, low calorie and physical activity
|
|
Aktiv komparator: Control
physical activity plus successful aging health education
|
physical activity plus successful aging health education
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
time to walk 400 m
Tidsramme: at 6 mo intervals
|
at 6 mo intervals
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
weight loss
Tidsramme: 6 month intervals
|
6 month intervals
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Anne B Newman, MD, MPH, University of Pittsburgh
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2008
Primær færdiggørelse (Faktiske)
1. december 2009
Datoer for studieregistrering
Først indsendt
9. juli 2008
Først indsendt, der opfyldte QC-kriterier
9. juli 2008
Først opslået (Skøn)
14. juli 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
13. januar 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. januar 2016
Sidst verificeret
1. januar 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PRO07040024
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .