NCT03027518

Brief Summary

The purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition in Beloit College students. This program is called "WILD 5 Wellness: A 30-Day Intervention". Results for this study will be quantified through the use of standardized self-report questionnaires administered prior to and after students complete the WILD 5 program (Group 1) or 30 days of inactive participation (Group 2), and again approximately 30 days later when the initially inactive group (Group 2) will have just completed their active participation in the WILD 5 program and the first WILD 5 group (Group 1) will be approximately 30 days out from completion of their WILD 5 active portion. Data will be collected to evaluate participants' adherence and response to each element of WILD 5, a 5-pronged 30-day wellness intervention. It is expected that this 30-day integrated, prescriptive, and trackable program will be found to be an efficacious wellness intervention for Beloit College students as compared to the control (inactive) group of students not participating in the Active program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

February 6, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2017

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

2 months

First QC Date

January 17, 2017

Last Update Submit

April 24, 2018

Conditions

Outcome Measures

Primary Outcomes (14)

  • WILD 5 Wellness Scale (W5WS), Assessing Change

    Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)

  • WILD 5 Wellness Elements (W5WE), Assessing Change

    Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)

  • WILD 5 Wellness Effort Scale (W5WES), Assessing Change

    Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)

  • WHO (World Health Organization) 5 Well-Being Index (1998 version), Assessing Change

    Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)

  • Social Connectedness Scale (SCS), Assessing Change

    Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)

  • Sleep Condition Indicator (SCI), Assessing Change

    Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)

  • Sheehan Disability Scale (SDS), Assessing Change

    Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)

  • Patient Health Questionnaire (PHQ-9), Assessing Change

    Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)

  • Mindful Attention Awareness Scale (MAAS), Day to Day Experiences, Assessing Change

    Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)

  • MIND ( Mediterranean-DASH Intervention for Neurodegenerative Delay)Diet, Assessing Change

    Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)

  • Generalized Anxiety Disorder (GAD-7), Assessing Change

    Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)

  • Eating and Appraisal Due to Emotions and Stress Questionnaire (EADES), Assessing Change

    Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)

  • Cognitive and Physical Functioning Questionnaire (CPFQ), Assessing Change

    Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)

  • Post Program Participant Questionnaire

    The end of the 30 day active participation in WILD 5 Wellness for each group (1 and 2)

Study Arms (2)

Group 1

OTHER

Group 1 will be active in the WILD 5 Wellness program the first 30 days and inactive the 2nd 30 days.

Other: WILD 5 Wellness

Group 2

OTHER

Group 2 will be inactive in the WILD 5 Wellness program the first 30 days and active the 2nd 30 days.

Other: WILD 5 Wellness

Interventions

Participants will be asked to voluntarily engage in integrated, prescriptive, and trackable wellness interventions combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.

Group 1Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Beloit College student enrolled in one or more of the following Spring 2017 academic courses:
  • Anthropology 201 01 "Research Designs: Sophomore Seminar in Anthropology"
  • Health and Society 240 B1 "Sophomore Seminar in Health and Society"
  • Spanish 218 "Health and Culture in the Spanish-Speaking World"
  • Biology 373 "Neuroscience Research"
  • Biology 215 "Emerging Diseases"

You may not qualify if:

  • Individuals who are \<18 years old
  • Individuals who are acutely suicidal and/or actively psychotic
  • Individuals who are pregnant or plan to get pregnant during the next 60 days, or who are not registered in one of the courses listed above.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beloit College

Beloit, Wisconsin, 53511, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2017

First Posted

January 23, 2017

Study Start

February 6, 2017

Primary Completion

April 18, 2017

Study Completion

December 5, 2017

Last Updated

April 26, 2018

Record last verified: 2018-04

Locations