Clinical trial NCT02652845: Wellness Engagement Project, Petersburg
Official title: Wellness Engagement Project, Petersburg
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Pathways-VA Inc
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2016-01-12
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Engagement in WE activities
timeFrame: 4-weeks
measure: Video lessons
timeFrame: 4 weeks
measure: Peer Support
timeFrame: 4 weeks
measure: Self-monitoring logs
timeFrame: 4 weeks
measure: Value of the program
timeFrame: 4 weeks
measure: Effectiveness of peer support
timeFrame: 4 weeks
Secondary outcomes:
measure: Uptake of key behaviors promoted in the WE program
timeFrame: 4-weeks
measure: Weight
timeFrame: 4-weeks
measure: Dietary changes
timeFrame: 4-weeks
measure: Height
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Maghboeba Mosavel, PhD
role: PRINCIPAL_INVESTIGATOR
References: