Wellness Engagement Project, Petersburg (WE)
8 januari 2016 uppdaterad av: 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
20
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Virginia
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Richmond, Virginia, Förenta staterna, 23298
- Virginia Commonwealth University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
12 år till 65 år (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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 |
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.
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Inget ingripande: 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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Engagement in WE activities
Tidsram: 4-weeks
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Number of community events attended
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4-weeks
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Video lessons
Tidsram: 4 weeks
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Number of video lessons viewed as reported to Wellness Ambassadors
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4 weeks
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Peer Support
Tidsram: 4 weeks
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number of check-in phone calls completed with Peer Support Coaches
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4 weeks
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Self-monitoring logs
Tidsram: 4 weeks
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number of self-monitoring logs completed
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4 weeks
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Value of the program
Tidsram: 4 weeks
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Perceived value of the program
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4 weeks
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Effectiveness of peer support
Tidsram: 4 weeks
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Perception of the effectiveness of the peer support received from peer coaches
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4 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Uptake of key behaviors promoted in the WE program
Tidsram: 4-weeks
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Engagement in recommended health behaviors
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4-weeks
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Weight
Tidsram: 4-weeks
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Weight will be measured in kg
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4-weeks
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Dietary changes
Tidsram: 4-weeks
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Dietary practices will be assessed using the Behavioral Risk Factor Surveillance System (BRFSS)
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4-weeks
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Height
Tidsram: 4 weeks
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height measured in meters
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4 weeks
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Maghboeba Mosavel, PhD, Virginia Commonwealth University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2015
Primärt slutförande (Faktisk)
1 augusti 2015
Avslutad studie (Faktisk)
1 augusti 2015
Studieregistreringsdatum
Först inskickad
5 juni 2015
Först inskickad som uppfyllde QC-kriterierna
8 januari 2016
Första postat (Uppskatta)
12 januari 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
12 januari 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 januari 2016
Senast verifierad
1 januari 2016
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 5R24MD008128 (U.S.S. NIH-anslag/kontrakt)
- 1R24MD008128 (U.S.S. NIH-anslag/kontrakt)
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