Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Wellness Engagement Project, Petersburg (WE)

8. januar 2016 opdateret af: Virginia Commonwealth University
This study tests the feasibility of a health and wellness trial designed with community input. This 12-week program will be tested over a 24-week period using a delayed treatment control group.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This 12-week program was designed based on input from Petersburg, VA community residents, collected through various methods over a two-year period. The 12 week program is designed to impact three levels: individual, family and community. At the individual level, participants receive print material lessons related to healthy eating and increasing physical activity, as well as videos that model these lessons; participants will also have access to a peer support coach who will contact them on a biweekly basis and are trained to help them identify and reach their own personal health goals. At the family level, participants are encouraged to share all of the information they receive as a part of this program with the rest of their family, and are asked to begin walking regularly and to attend fitness and nutrition classes held within their neighborhood (by the WE program) with family members. On a community level, local church groups and neighborhood organizations will receive assistance in launching walking clubs, and all community residents are invited to attend the physical activity and nutrition classes that the WE project hosts within the community.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23298
        • Virginia Commonwealth University

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

12 år til 65 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age between 18-65 years.
  • Must have a school going child between 12-17 living in the home.
  • BMI between 25 and 50 kg/m2.

Exclusion Criteria:

  • report not being able to walk 2 blocks (1/4 mile) without stopping
  • currently participating in another weight loss program
  • taking a weight loss medication
  • have a history of bariatric surgery
  • pregnant or plan to become pregnant during the intervention timeframe
  • report an unsupervised heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire
  • report a medical condition that would jeopardize their safety if involved in a weight management program with diet and exercise guidelines (e.g., uncontrolled heart problem)
  • fail medical screening by study medical staff)
  • report conditions that, in the judgment of the PI, would render the participant unlikely to follow the study protocol (e.g., planned move from the area, dementia, substance abuse).

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: Intervention-Wellness Engagement Program

The group assigned to the intervention arm will receive treatment as described below for a twelve week period:

Weekly lessons related to healthy eating and physical activity Biweekly check-in calls with a trained peer support coach Access to neighborhood wide physical activity and nutritional education events
Adfærdsmæssigt: Wellness Engagement Program
This intervention is an evidence based and community informed program designed to stimulate physical activity and increase healthy food choices among participants. The intervention includes weekly lessons, personal support in the form of biweekly check in calls with a peer support coach and weekly physical activity and nutrition classes.
Ingen indgriben: Delayed treatment control group
The delayed treatment control group will not receive the intervention for measurement purposes; however the intervention as described will be administered to this group upon conclusion of the 12 week period for the intervention group.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Engagement in WE activities
Tidsramme: 4-weeks
Number of community events attended
4-weeks
Video lessons
Tidsramme: 4 weeks
Number of video lessons viewed as reported to Wellness Ambassadors
4 weeks
Peer Support
Tidsramme: 4 weeks
number of check-in phone calls completed with Peer Support Coaches
4 weeks
Self-monitoring logs
Tidsramme: 4 weeks
number of self-monitoring logs completed
4 weeks
Value of the program
Tidsramme: 4 weeks
Perceived value of the program
4 weeks
Effectiveness of peer support
Tidsramme: 4 weeks
Perception of the effectiveness of the peer support received from peer coaches
4 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Uptake of key behaviors promoted in the WE program
Tidsramme: 4-weeks
Engagement in recommended health behaviors
4-weeks
Weight
Tidsramme: 4-weeks
Weight will be measured in kg
4-weeks
Dietary changes
Tidsramme: 4-weeks
Dietary practices will be assessed using the Behavioral Risk Factor Surveillance System (BRFSS)
4-weeks
Height
Tidsramme: 4 weeks
height measured in meters
4 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Virginia Commonwealth University

Samarbejdspartnere

National Institute on Minority Health and Health Disparities (NIMHD)
Pathways-VA Inc

Efterforskere

  • Ledende efterforsker: Maghboeba Mosavel, PhD, Virginia Commonwealth University

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 2015

Primær færdiggørelse (Faktiske)

1. august 2015

Studieafslutning (Faktiske)

1. august 2015

Datoer for studieregistrering

Først indsendt

5. juni 2015

Først indsendt, der opfyldte QC-kriterier

8. januar 2016

Først opslået (Skøn)

12. januar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. januar 2016

Sidst verificeret

1. januar 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 5R24MD008128 (U.S. NIH-bevilling/kontrakt)
  • 1R24MD008128 (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 .

Kliniske forsøg med Wellness Engagement Program

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Greece

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner