- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00569595
Improving Health Habits in Impoverished Populations
6. juni 2011 opdateret af: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Poor diet, physical inactivity, and sedentary behaviors among low-income, minority populations have been linked to greater risk of chronic health conditions such as overweight/obesity, cardiovascular disease, and type 2 diabetes.
Low-income clinics that serve these populations often represent an untapped opportunity for health promotion in impoverished individuals.
This exploratory project proposes to address this scientific gap by introducing and conducting a randomized controlled pilot of the Self-Care Stimulating Disease Prevention Program to address poor dietary habits, physical inactivity, and sedentary lifestyle behaviors among low income, uninsured patient populations.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Poor diet, physical inactivity, and sedentary behaviors among low-income, minority populations have been linked to greater risk of chronic health conditions such as overweight/obesity, cardiovascular disease, and type 2 diabetes.
Low-income clinics that serve these populations often represent an untapped opportunity for health promotion in impoverished individuals.
Few studies have examined the feasibility of using brief physician advice and multi-level, clinic-based interventions to change poor dietary habits, physical inactivity, and sedentary lifestyle behaviors among these culturally diverse populations that comprise the clinic population.
This exploratory project proposes to address this scientific gap by introducing and piloting a Self-Care Stimulating Disease Prevention Program (SCSDPP) to address poor dietary habits, physical inactivity, and sedentary lifestyle behaviors among low income, uninsured patient populations (primarily Latinos) served by the community clinics of the Venice Family Clinic (VFC) health center in Los Angeles County.
The program will include the development of 1) a simple-to-use patient Health Priority Assessment (HPA) tool designed to assess patient preferences for behavior change; 2) a standard protocol for physicians to provide brief health advice using motivation interviewing (< 2 minutes per visit); 3) a protocol for distributing self-help aids for patient use (e.g., pedometer, exercise videos); and 4) a series of monthly follow-up counseling sessions by lay health educators (e.g., promotores) to help patients address their lifestyle change priorities over time.
We will conduct a randomized controlled pilot of the SCSDPP in approximately 100 patient cases at two community health clinics within the VFC health center system.
The pilot will utilize precise outcome measures, including commonly-accepted biomarkers (e.g., HgbA1c, fasting blood glucose) and psychometrically-validated measures of process and health status, to accurately assess the magnitude of changes in diet and physical activity among patients over a 12-month observation period.
The feasibility of integrating the SCSDPP into the community health clinic setting will be evaluated, and is the primary aim of this project.
The results will inform efforts to plan a larger, successor study.
Relevance to Public Health: this study evaluates a clinic-based brief intervention to help prevent overweight/obesity, a public health problem that has been linked to the development of the metabolic syndrome and other precursors of diabetes.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
100
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
Los Angeles, California, Forenede Stater, 90024
- UCLA Department of Family Medicine
-
Los Angeles, California, Forenede Stater, 90028
- Queenscare Family Clinics
-
-
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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Ages 18 and older
- English or Spanish-speaking
- Accessible by telephone or in person over time
- Willing to cooperate with data collection
- Planning to be in the Los Angeles area for the next 6 to 12 months so they can complete the study period
Exclusion Criteria:
- Women who are pregnant
- History of cancer, except non-melanoma skin cancer or in situ cancers
- Medical conditions preventing free choice of foods (e.g., colitis, poorly-controlled diabetes)
- Medical conditions precluding participation in common forms of aerobic or resistance exercise (e.g., uncontrolled angina, asthma or hypertension; severe physical impairment; and end-stage disease conditions such as congestive heart failure, nephropathy from any cause, or advanced chronic pulmonary disease)
- Does not show any desire to change any of their health behaviors (i.e., healthy eating, physical activity, sedentary behavior, or control their weight)
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: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 1
Multi-Level, Patient-Directed, Lifestyle Change, Health Promotion Program
|
The intervention is aimed at improving diet, increasing physical activity, and reducing sedentary behaviors among low-income patients, assuming that this will increase motivation and self-confidence to adhere to self-care regimens based on personal prioritizing and progressive goal setting.
|
|
Sham-komparator: 2
Patient health counseling program by lay health educators Entitled "Fighting Cancer with Advice."
|
Patient health counseling program by lay health educators entitled "Fighting Cancer with Advice."
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Serum glycosylated hemoglobin, heart rate recovery step test
Tidsramme: 4 and 6 months
|
4 and 6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Total Cholesterol, BMI, waist circumference, healthy eating, physical activity, perceived health status, patient satisfaction, mood
Tidsramme: 4 and 6 months
|
4 and 6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Lillian Gelberg, MD, MSPH, UCLA Department of Family Medicine
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. november 2008
Primær færdiggørelse (Faktiske)
1. november 2009
Studieafslutning (Faktiske)
1. november 2009
Datoer for studieregistrering
Først indsendt
5. december 2007
Først indsendt, der opfyldte QC-kriterier
6. december 2007
Først opslået (Skøn)
7. december 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
7. juni 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. juni 2011
Sidst verificeret
1. juni 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R21 DK71065 (completed)
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 .
Kliniske forsøg med Self-Care Stimulating Disease Prevention Program
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)Afsluttet
-
University of Maryland, BaltimoreTrukket tilbageDiabetes | Fed lever | Ændringer i kropsvægt | Præ-diabetesForenede Stater