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临床试验/NCT02652845
NCT02652845终止不适用

Wellness Engagement Project, Petersburg

Virginia Commonwealth University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
20
试验地点
1
主要终点
Engagement in WE activities

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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).

研究组 & 干预措施

Intervention-Wellness Engagement Program

Experimental

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

干预措施: Wellness Engagement Program (Behavioral)

Delayed treatment control group

No Intervention

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.

结局指标

主要结局

Engagement in WE activities

时间窗: 4-weeks

Number of community events attended

Video lessons

时间窗: 4 weeks

Number of video lessons viewed as reported to Wellness Ambassadors

Peer Support

时间窗: 4 weeks

number of check-in phone calls completed with Peer Support Coaches

Self-monitoring logs

时间窗: 4 weeks

number of self-monitoring logs completed

Value of the program

时间窗: 4 weeks

Perceived value of the program

Effectiveness of peer support

时间窗: 4 weeks

Perception of the effectiveness of the peer support received from peer coaches

次要结局

  • Uptake of key behaviors promoted in the WE program(4-weeks)
  • Height(4 weeks)
  • Weight(4-weeks)
  • Dietary changes(4-weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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