NCT03328520

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 First Year Beloit College students self-selected into a wellness focused first year initiative. This program is called "WILD 5 Wellness: A 30-Day Intervention".

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable anxiety

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

October 20, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

October 24, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2017

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

1 month

First QC Date

October 20, 2017

Last Update Submit

April 24, 2018

Conditions

AnxietyDepressionCognitive FunctioningWellness

Outcome Measures

Primary Outcomes (5)

  • Change in Patient Health Questionnaire-9 (PHQ-9)

    PHQ-9 is a self reported depression scale. It is a 9-item scale with scores ranging from 0-27. Lower scores denote improvement.

    Day 0, Day 30+ 3 days (approximately)

  • Change in Generalized Anxiety Disorder-7 (GAD-7)

    GAD-7 is a self-reported questionnaire used to assess anxiety symptoms. It is a 7-item scale with scores ranging from 0-21. Lower score denotes improvement.

    Day 0, Day 30+ 3 days (approximately)

  • Change in the HERO Wellness Scale

    HERO Wellness Scale is a brief scale designed to measure mental wellness specifically happiness, enthusiasm, resilience and optimism. It is a 5-item scale with scores ranging from 0-10. Higher score denotes improvement.

    Day 0, Day 30+ 3 days (approximately)

  • Change in World Health Organization-5 (WHO-5)

    WHO-5 is a brief scale that measures mental well-being. It is a 5-item scale with scores ranging from 0-25. Higher score denotes improvement.

    Day 0, Day 30+ 3 days (approximately)

  • Change in Cognitive and Physical Functioning Questionnaire (CPFQ)

    CPFQ is a brief scale that measures cognitive and executive dysfunction. It is a 7-item scale with scores ranging from 7-42. Lower score denotes improvement.

    Day 0, Day 30+ 3 days (approximately)

Secondary Outcomes (1)

  • The Post-Program Participant Questionnaire

    Day 30+ 3 days (approximately)

Study Arms (1)

First Year Students in Wellness FYIs

EXPERIMENTAL
Behavioral: WILD 5 Wellness Intervention

Interventions

WILD 5 Wellness InterventionBEHAVIORAL

Behaviors in 6 areas of wellness: Sleep, Social Connectedness, Exercise, Nutrition, Mindfulness and "HERO" (Happiness, Enthusiasm, Resilience, Optimism)

First Year Students in Wellness FYIs

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Students 18 years of age or older or 17 years of age with legal guardian written permission.
  • Students enrolled in First Year Initiative Courses titled "Balance" or "Constructing Health"

You may not qualify if:

  • Individuals who are pregnant or plan to get pregnant during the next 30 days.
  • Students who are not enrolled in the First Year Initiative Courses titled "Balance" or "Constructing Health"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beloit College

Beloit, Wisconsin, 53511, United States

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Tara M Girard, BSN

    Beloit College

    PRINCIPAL INVESTIGATOR

  • Suzanne Cox, PhD

    Beloit College

    PRINCIPAL INVESTIGATOR

  • Laura Parmentier, PhD

    Beloit College

    PRINCIPAL INVESTIGATOR

  • Saundra Jain, PsyD, LPC

    Beloit College

    PRINCIPAL INVESTIGATOR

  • Rakesh Jain, MD, MPH

    Beloit College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2017

First Posted

November 1, 2017

Study Start

October 24, 2017

Primary Completion

November 29, 2017

Study Completion

November 29, 2017

Last Updated

April 26, 2018

Record last verified: 2018-04

Locations

US(1)