NCT05498415

Brief Summary

The overarching goal for this project is to develop a service-learning program that provides students excellent hands on training and patients with an excellent service that advances their health and well-being. The aim of this study is to test the feasibility, acceptability and efficacy of an 8 week intervention on physical behaviors, cognitive function, and health outcomes compared to a control condition among sedentary, overweight and obese adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

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

July 28, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2023

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

July 28, 2022

Last Update Submit

May 11, 2023

Conditions

Physical InactivitySedentary BehaviorSleepCognitive Function

Outcome Measures

Primary Outcomes (3)

  • Physical activity

    Daily steps will be measured with an ActivPAL monitor

    Change from baseline daily steps at 8 weeks

  • Sedentary Behavior

    Daily minutes spent sedentary will be measured with an ActivPAL monitor

    Change from baseline daily minutes sedentary at 8 weeks

  • Sleep

    Daily minutes spent sleeping will be measured with an ActivPAL monitor

    Change from baseline daily minutes spent sleeping at 8 weeks

Secondary Outcomes (1)

  • Cognitive function

    Change from baseline cognitive function at 8 weeks

Study Arms (2)

Education

ACTIVE COMPARATOR

Participants will receive basic education information on physical activity, sedentary behavior, and sleep for 8 weeks.

Behavioral: Education

Education + Health Coaching + Activity Monitor

EXPERIMENTAL

Participants will receive education information on physical activity, sedentary behavior and sleep plus health coaching plus a Fitbit activity monitor for 8 weeks.

Behavioral: EducationBehavioral: Health coachingBehavioral: Activity Monitor

Interventions

EducationBEHAVIORAL

Participants will receive standard of care education information on physical activity, sedentary behavior, and sleep via a mobile app for 8 weeks.

EducationEducation + Health Coaching + Activity Monitor
Health coachingBEHAVIORAL

Participants will meet with a health coach weekly for 8 weeks

Education + Health Coaching + Activity Monitor
Activity MonitorBEHAVIORAL

Participants will receive a Fitbit activity monitor to support goal setting and self monitoring of behaviors.

Education + Health Coaching + Activity Monitor

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physically inactive
  • Overweight or obese
  • Healthy enough to safely engage in regular physical activity

You may not qualify if:

  • \<18 years or \>80 years
  • Report achieving more than 75 minutes/week of moderate to vigorous intensity physical activity
  • Underweight or normal weight (BMI \<25.0 mg/kg2)
  • Do not intend on becoming more active in the next 3 months
  • Not able to commit to a 8 week physical activity program
  • No access to smartphone capable of sending and receiving text messages
  • Self report mobility issues or diagnosed diseases that prevent safely engaging in regular physical activity
  • Planned surgery in the next 12 weeks
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Educational StatusFitness Trackers

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsDiagnostic EquipmentEquipment and SuppliesWearable Electronic DevicesElectrical Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be randomly assigned to group A (control) or group B (treatment) but will not be told which group they are receiving.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 28, 2022

First Posted

August 12, 2022

Study Start

September 1, 2022

Primary Completion

March 27, 2023

Study Completion

March 27, 2023

Last Updated

May 12, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

The investigators do not plan to share IPD with other researchers.

Locations

US(1)