Wellness Engagement Project, Petersburg

Obesity Clinical Trial

— WE  

Official title:

Wellness Engagement Project, Petersburg

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02652845
• Other study ID #: 5R24MD008128
• Secondary ID: 1R24MD008128
• Status: Terminated
• Phase: N/A
• First received: June 5, 2015
• Last updated: January 8, 2016
• Start date: March 2015
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute on Minority Health and Health Disparities (NIMHD), Pathways-VA Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Engagement in WE activities	Number of community events attended	4-weeks	No
Primary	Video lessons	Number of video lessons viewed as reported to Wellness Ambassadors	4 weeks	No
Primary	Peer Support	number of check-in phone calls completed with Peer Support Coaches	4 weeks	No
Primary	Self-monitoring logs	number of self-monitoring logs completed	4 weeks	No
Primary	Value of the program	Perceived value of the program	4 weeks	No
Primary	Effectiveness of peer support	Perception of the effectiveness of the peer support received from peer coaches	4 weeks	No
Secondary	Uptake of key behaviors promoted in the WE program	Engagement in recommended health behaviors	4-weeks	No
Secondary	Weight	Weight will be measured in kg	4-weeks	No
Secondary	Dietary changes	Dietary practices will be assessed using the Behavioral Risk Factor Surveillance System (BRFSS)	4-weeks	No
Secondary	Height	height measured in meters	4 weeks	No