WE: Wellness Engagement Project, Petersburg

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Terminated
CT.gov ID
NCT02652845
Collaborator
Pathways-VA Inc (Other), National Institute on Minority Health and Health Disparities (NIMHD) (NIH)
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Wellness Engagement Program
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Wellness Engagement Project, Petersburg
Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
Aug 1, 2015
Actual Study Completion Date :
Aug 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Engagement in WE activities [4-weeks]

    Number of community events attended

  2. Video lessons [4 weeks]

    Number of video lessons viewed as reported to Wellness Ambassadors

  3. Peer Support [4 weeks]

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

  4. Self-monitoring logs [4 weeks]

    number of self-monitoring logs completed

  5. Value of the program [4 weeks]

    Perceived value of the program

  6. Effectiveness of peer support [4 weeks]

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

Secondary Outcome Measures

  1. Uptake of key behaviors promoted in the WE program [4-weeks]

    Engagement in recommended health behaviors

  2. Weight [4-weeks]

    Weight will be measured in kg

  3. Dietary changes [4-weeks]

    Dietary practices will be assessed using the Behavioral Risk Factor Surveillance System (BRFSS)

  4. Height [4 weeks]

    height measured in meters

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Virginia Commonwealth University Richmond Virginia United States 23298

Sponsors and Collaborators

  • Virginia Commonwealth University
  • Pathways-VA Inc
  • National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Maghboeba Mosavel, PhD, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT02652845
Other Study ID Numbers:
  • 5R24MD008128
  • 1R24MD008128
First Posted:
Jan 12, 2016
Last Update Posted:
Jan 12, 2016
Last Verified:
Jan 1, 2016

Study Results

No Results Posted as of Jan 12, 2016