Wellness Engagement Project, Petersburg (WE)

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.

Study Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Wellness Engagement Program

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); Pathways-VA Inc
• Investigators: Principal Investigator: Maghboeba Mosavel, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: June 5, 2015
• First Submitted That Met QC Criteria: January 8, 2016
• First Posted (Estimate): January 12, 2016

Study Record Updates

• Last Update Posted (Estimate): January 12, 2016
• Last Update Submitted That Met QC Criteria: January 8, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 5R24MD008128 (U.S. NIH Grant/Contract); 1R24MD008128 (U.S. NIH Grant/Contract)