- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02960542
HELP Prevent Cancer Pilot Study (HELP PC)
18. juni 2020 opdateret af: Wake Forest University Health Sciences
Healthy Living Partnerships to Prevent Cancer (HELP PC) Pilot Study
This pilot study is designed to adapt a community-based diabetes prevention program to reach adults at risk for cancer.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
The Healthy Living Partnerships to Prevent Diabetes (HELP PD) study successfully translated the Diabetes Prevention Program (DPP) weight-loss lifestyle intervention in Winston-Salem, North Carolina by delivering the intervention via a partnership between a local diabetes education program with lay community health workers.
This study documented a 7% weight loss and 4 mg/dl decrease in fasting blood glucose in patients with prediabetes in 1 year at promote healthy weight loss (1-2 pounds per week).
These lifestyle strategies significantly lower costs than the DPP.
The HELP PD lifestyle intervention focuses on restricting calories (while improving dietary quality) and increasing physical activity to allow participants to achieve an energy deficient state to are essential to reduce risk for type 2 diabetes but also for a multitude of chronic diseases where excess body weight plays a critical role in the development and exacerbation of the disease.
In light of the community-based partnership on which HELP PD was based and the relatively low costs of program administration, the HELP PD model has the potential to be a highly effective and sustainable long-term approach to cancer prevention as well.
This pilot study will be the initial step to determine feasibility of implementing the Healthy Living Partnerships to Prevent Cancer (HELP PC) in the Dan River Region of Southern Virginia through a partnership between researchers and colleagues from Wake Forest Comprehensive Cancer Center, Virginia Polytechnic Institute and State University, Danville Hematology and Oncology at the Danville Regional Medical Center, Resource Center of Southern Virginia in Danville, and Danville Regional Medical Center.
Wake Forest will serve as the lead site in this study.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
21
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Virginia
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Danville, Virginia, Forenede Stater, 24541
- Danville Regional Medical Center
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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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- English Proficiency: Able to read/understand English at or above a level sufficient to comprehend recruitment and intervention materials.
- Body Mass Index: BMI > 25 kg/m2.
Exclusion Criteria:
- Weight Loss: Currently involved in a supervised program for weight loss.
- Medications: Use of insulin or other diabetes medications that would require additional medical monitoring during weight-loss; use of medications for weight loss or that may impact weight or glucometabolic function (e.g. corticosteroids).
- Recent History of Cardiovascular Disease: Clinical history of cardiovascular disease (CVD) occurring within the past 6 months, including myocardial infarction, angina, coronary revascularization, stroke, transient ischemic attack (TIA), carotid revascularization, peripheral arterial disease, and congestive heart failure.
- Hypertension: Uncontrolled high blood pressure: BP > 160/100. Persons can be re-screened after controlled.
- Pregnancy: Pregnancy, breast feeding, or planning pregnancy within 1 year.
- Other Chronic Conditions: Other chronic disease likely to limit lifespan to less than 2-3 years, including any cancer requiring treatment in past 5 years except non-melanoma skin cancer.
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Lifestyle Weight Loss
The Behavioral: HELP Prevent Cancer Intervention is a lifestyle intervention consisting of 24-weekly group meetings led by a community health worker and 3 individual sessions with a nutritionist/diabetes educator
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This Behavioral: Lifestyle Weigh Loss Intervention involves a dietary weight-loss program and an increase in caloric expenditure through moderate physical activity.
The primary treatment objectives for the weight-loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight-loss of .3
kg/week for a total weight loss of 5-7%.
The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 minutes/week.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Recruitment of 20 eligible study participants
Tidsramme: 6 months
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Develop and evaluate a feasible referral system to facilitate participant enrollment into the HELP PC intervention (measured by number screened and enrolled)
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6 months
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Retention of study participants
Tidsramme: 6 months
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Measure retention to the HELP PC intervention (measured by number of participants attending the closeout visit after 26 weeks of intervention)
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6 months
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Attendance at group sessions
Tidsramme: 6 months
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Assess participant adherence to attending the HELP PC intervention sessions (measured by community health worker documentation of session attendance)
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6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Blood Pressure
Tidsramme: 6 months
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Estimate the means and standard deviations at baseline and 6 months.
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6 months
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Weight
Tidsramme: 6 months
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Estimate the means and standard deviations at baseline and 6 months.
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6 months
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Glucose
Tidsramme: 6 months
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Estimate the means and standard deviations at baseline and 6 months.
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6 months
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Insulin
Tidsramme: 6 months
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Estimate the means and standard deviations at baseline and 6 months.
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6 months
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Cholesterol
Tidsramme: 6 months
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Estimate the means and standard deviations at baseline and 6 months.
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6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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)
26. juni 2017
Primær færdiggørelse (Faktiske)
4. april 2018
Studieafslutning (Faktiske)
4. april 2018
Datoer for studieregistrering
Først indsendt
31. oktober 2016
Først indsendt, der opfyldte QC-kriterier
7. november 2016
Først opslået (Skøn)
9. november 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. juni 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. juni 2020
Sidst verificeret
1. juni 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- IRB00039102
Plan for individuelle deltagerdata (IPD)
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Kliniske forsøg med HELP Prevent Cancer Intervention
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University of BernAfsluttetDepression Moderat | Depression MildSchweiz