- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01664715
A Randomized Trial of Recommendations for Exercise to Prevent Weight Regain (POWeR)
16. april 2019 opdateret af: Joseph Donnelly, University of Kansas
The investigators will conduct a randomized trial to evaluate the effectiveness of 3 levels of recommended exercise in initially overweight and obese sedentary men and women on the prevention of weight regain.
Participants will complete a 3 mo.
weight loss intervention of decreased energy intake (EI) and increased energy expenditure (100 minutes of physical activity per week).
Participants achieving clinically significant weight loss (> 5% of initial weight), will be randomly assigned to 12 mos. of exercise at levels of energy expenditure of exercise (EEEx) recommended by Health and Human Services (HHS), American College of Sports Medicine(ACSM), Institute of Medicine (IOM): 150, 225, or 300 minutes per week.
Major outcome assessments will occur prior to weight loss (-3 mos.), at completion of weight loss (0 mos.), at the midpoint (6 mos.), and completion of weight maintenance (12 mos.).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The investigators propose a randomized trial in 287 overweight and obese, sedentary adults (at least 50% women).
Participants achieving clinically significant weight loss (≥5%) following a 3 mo.
reduced energy diet and a program of PA (100 min/wk) will be randomly assigned to either maintain exercise at 150 min/wk.
or increase exercise to 225 min/wk or 300 min/wk.
while consuming a weight gain prevention diet over a 12 mo.
period.
Exercise will be verified (combination of on-site and HR monitor) and EEEx will be measured at 5 mo.
intervals beginning at mo. 5. In-person behaviorally based clinic meetings will be conducted weekly during the 3 mo.
weight loss period (-3 to 0 mos.) and during the first 3 mos. of the weight regain prevention period.
During the final 9 mos. of weight regain prevention, clinics will be held bi-monthly using group conference calls.
We have not proposed to randomize participants to a true control group (i.e.
no exercise or diet) following the 3 mo.
weight loss program as published data indicates significant weight regain in individuals receiving no follow-up treatment after weight loss.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
287
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Kansas
-
Lawrence, Kansas, Forenede Stater, 66045
- University of Kansas - Robinson Hall
-
-
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
21 år til 55 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age 21 to 55 years.
- BMI of 25 to 45.0.
- Clearance for participation from their Primary Care Physician (PCP)
Exclusion Criteria:
- Participation in a research project involving weight loss or exercise in the previous 6 mos., as these proximal experiences may impact the results of this study.
- Participation in a regular exercise program (i.e., > 500 kcal/wk. of planned activity as estimated by questionnaire)
- Not weight stable (+ or - 4.5 kg) for 3 mos. prior to intake.
- Unwilling to be randomized to 1 of 3 exercise groups subsequent to weight loss.
- Pregnant during the previous 6 mos., lactating, or planned pregnancy in the following 15 mos.
- Serious medical risk such as type 1 diabetes, cancer, recent cardiac event (i.e., heart attack, angioplasty, etc.). This is determined by the individual's physician via the clearance to participate in the investigation and the health history (Appendix) interpreted by the staff physician.
- Eating disorders as determined by the Eating Attitudes Test using a score of 20 or greater
- Current treatment for psychological problems, or taking psychotropic medications
- Medications known to significantly affect weight (gain or loss).
- Adherence to specialized diet regimens, i.e., multiple food allergies, vegetarian, macrobiotic, etc.
- Do not have access to grocery shopping and meal preparation (i.e. those in military, college with cafeteria plan, etc.).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 150 Minutes per Week
Performs 150 minutes of physical activity per week.
|
Performs 150 min/wk of planned moderate intensity aerobic exercise.
|
Aktiv komparator: 225 Minutes per Week
Performs 225 minutes of physical activity per week.
|
Performs 225 min/wk of planned moderate intensity aerobic exercise.
|
Aktiv komparator: 300 Minutes per Week
Performs 300 minutes of physical activity per week.
|
Performs 300 min/wk of planned moderate intensity aerobic exercise.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Prevention of Weight Regain
Tidsramme: 12 Months
|
To compare the effectiveness of 3 exercise recommendations on the prevention of weight regain over 12 mos.
subsequent to clinically significant weight loss (> 5%).
We expect participants will regain weight in a dose-response manner, i.e. greatest, intermediate and least weight regain for the 150, 225, and 300 minute.
groups, respectively.
|
12 Months
|
Gender Differences in Weight Regain
Tidsramme: 12 Months
|
To evaluate gender differences in weight regain over 12 months in response to 3 exercise recommendations.
Based on available preliminary data we expect men will regain less weight than women.
|
12 Months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Compensatory Changes to three exercise levels
Tidsramme: 12 Months
|
Evaluating the impact of potential compensatory changes in daily physical activity and energy intake on weight regain in response to 3 exercise recommendations.
Any observed compensatory responses would inform the development of subsequent targeted interventions.
|
12 Months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Joseph Donnelly, EdD, University of Kansas
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.
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 (Faktiske)
1. august 2012
Primær færdiggørelse (Faktiske)
1. april 2018
Studieafslutning (Faktiske)
31. december 2018
Datoer for studieregistrering
Først indsendt
10. august 2012
Først indsendt, der opfyldte QC-kriterier
10. august 2012
Først opslået (Skøn)
14. august 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. april 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. april 2019
Sidst verificeret
1. april 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HSCL19775
- R01HL111842 (U.S. NIH-bevilling/kontrakt)
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 .
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