- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02960542
HELP Prevent Cancer Pilot Study (HELP PC)
18. juni 2020 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
21
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Virginia
-
Danville, Virginia, Forente stater, 24541
- Danville Regional Medical Center
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Recruitment of 20 eligible study participants
Tidsramme: 6 months
|
Develop and evaluate a feasible referral system to facilitate participant enrollment into the HELP PC intervention (measured by number screened and enrolled)
|
6 months
|
Retention of study participants
Tidsramme: 6 months
|
Measure retention to the HELP PC intervention (measured by number of participants attending the closeout visit after 26 weeks of intervention)
|
6 months
|
Attendance at group sessions
Tidsramme: 6 months
|
Assess participant adherence to attending the HELP PC intervention sessions (measured by community health worker documentation of session attendance)
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Blood Pressure
Tidsramme: 6 months
|
Estimate the means and standard deviations at baseline and 6 months.
|
6 months
|
Weight
Tidsramme: 6 months
|
Estimate the means and standard deviations at baseline and 6 months.
|
6 months
|
Glucose
Tidsramme: 6 months
|
Estimate the means and standard deviations at baseline and 6 months.
|
6 months
|
Insulin
Tidsramme: 6 months
|
Estimate the means and standard deviations at baseline and 6 months.
|
6 months
|
Cholesterol
Tidsramme: 6 months
|
Estimate the means and standard deviations at baseline and 6 months.
|
6 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
26. juni 2017
Primær fullføring (Faktiske)
4. april 2018
Studiet fullført (Faktiske)
4. april 2018
Datoer for studieregistrering
Først innsendt
31. oktober 2016
Først innsendt som oppfylte QC-kriteriene
7. november 2016
Først lagt ut (Anslag)
9. november 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. juni 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. juni 2020
Sist bekreftet
1. juni 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- IRB00039102
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på HELP Prevent Cancer Intervention
-
IWK Health CentreMcGill University; Canadian Institutes of Health Research (CIHR); University... og andre samarbeidspartnereAktiv, ikke rekrutterende
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)FullførtOpposisjonell Defiant Disorder | AtferdsforstyrrelseCanada
-
VA Office of Research and DevelopmentVA Connecticut Healthcare System; US Department of Veterans AffairsFullført
-
University of BernFullførtDepresjon Moderat | Depresjon MildSveits