NCT02652845

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

5 months

First QC Date

June 5, 2015

Last Update Submit

January 8, 2016

Conditions

Obesity

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (4)

  • Uptake of key behaviors promoted in the WE program

    4-weeks

  • Weight

    4-weeks

  • Dietary changes

    4-weeks

  • Height

    4 weeks

Study Arms (2)

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

Behavioral: Wellness Engagement Program

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.

Interventions

Wellness Engagement ProgramBEHAVIORAL

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.

Intervention-Wellness Engagement Program

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maghboeba Mosavel, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2015

First Posted

January 12, 2016

Study Start

March 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations

US(1)