NCT03272555

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

September 5, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2017

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2017

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

1 month

First QC Date

August 29, 2017

Last Update Submit

April 24, 2018

Conditions

Outcome Measures

Primary Outcomes (5)

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

    PHQ-9 is a self reported depression scale.

    Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)

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

    GAD-7 is a self-reported questionnaire used to assess anxiety symptoms.

    Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)

  • Change in The HERO Wellness Scale

    The HERO Wellness Scale is a brief scale designed to measure mental wellness specifically happiness, enthusiasm, resilience and optimism.

    Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)

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

    WHO-5 is a brief scale that measures mental well-bring.

    Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)

  • Change in Cognitive and Physical Functioning Questionnaire (CPFQ)

    CPFQ is a brief scale that measures cognitive and executive dysfunction.

    Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)

Secondary Outcomes (1)

  • The Post-Program Participant Questionnaire

    Day 31+/- 5 days

Study Arms (1)

Study Participants

OTHER

The participants in this arm will engage in the WILD 5 Wellness activities combining five wellness elements including exercise, mindfulness, sleep, social connectedness and nutrition.

Other: WILD 5 Wellness Interventions

Interventions

Students enrolled in the study will be asked to complete activities in five wellness elements including exercise, mindfulness, sleep, social connectedness and nutrition for 30 days.

Study Participants

Eligibility Criteria

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

You may qualify if:

  • students 18 years of age or older
  • students enrolled in First Year Initiative Course titled, "Habits of Mind, Habits of Body."

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 Course titled, "Habits of Mind, Habits of Body".

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 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

August 29, 2017

First Posted

September 5, 2017

Study Start

September 5, 2017

Primary Completion

October 10, 2017

Study Completion

October 13, 2017

Last Updated

April 26, 2018

Record last verified: 2018-04

Locations