NCT07114991

Brief Summary

This study will evaluate the effects of using a pedal-assist electric bicycle (e-bike) for commuting on physical activity, fitness, and health in overweight or obese college students. Participants will be randomly assigned to either a 12-week e-bike commuting intervention or a control group. The study will measure changes in cardiorespiratory fitness, body composition, blood biomarkers, physical activity, and psychological well-being over a 24-week period.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress87%
May 2025Jun 2026

Study Start

First participant enrolled

May 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

1.2 years

First QC Date

August 4, 2025

Last Update Submit

August 4, 2025

Conditions

Keywords

Electric bicycleActive commutingExercise motivationHealth behaviorPhysical activityOverweight

Outcome Measures

Primary Outcomes (2)

  • Change in daily moderate-to-vigorous physical activity (minutes/day)

    Physical activity will be measured using a hip-worn ActiGraph GT3X+ accelerometer over 7 consecutive days at baseline, Week 12, and Week 24. The device will be analyzed using validated cut points to determine average daily time spent in moderate-to-vigorous physical activity (MVPA). The primary outcome is the change in MVPA from baseline to Week 24

    From enrollment to end of study at 24 weeks.

  • Change in cardiorespiratory fitness (VO₂peak, mL/kg/min)

    Cardiorespiratory fitness will be measured via a graded cycling test using a metabolic cart to determine peak oxygen uptake (VO₂peak). Participants will complete the test at baseline (Week 0), post-intervention (Week 12), and follow-up (Week 24). The primary comparison will be the change in VO₂peak from baseline to Week 12 between the intervention and control groups.

    From enrollment to end of study at 24 weeks.

Secondary Outcomes (4)

  • Change in body fat percentage

    From enrollment to end of study at 24 weeks.

  • Change in total cholesterol, HDL-C, LDL-C, and triglycerides (mg/dL)

    From enrollment to end of study at 24 weeks.

  • Change in fasting blood glucose (mg/dL)

    From enrollment to end of study at 24 weeks.

  • Change in exercise motivation (BREQ-3 score)

    From enrollment to end of study at 24 weeks.

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants in this group will receive a pedal-assist electric bicycle (e-bike), helmet, safety training, and cycling computer. They will be instructed to use the e-bike for commuting or transportation at least four days per week for 12 weeks. They will also complete assessments at baseline, Week 12, and Week 24, including fitness testing, body composition, blood testing, surveys, and activity monitoring.

Behavioral: E-Bike Commuting

Control Group

NO INTERVENTION

Participants in the control group will maintain their usual commuting and physical activity habits for the 12-week intervention period. They will complete the same assessments as the intervention group at baseline, Week 12, and Week 24.

Interventions

Participants in the intervention group will receive a pedal-assist electric bicycle (e-bike), a helmet, safety training, and a cycling computer. They will be asked to use the e-bike for commuting or personal travel at least four times per week for 12 weeks. E-bike usage will be monitored using a Garmin Edge device. Participants will also complete baseline, 12-week, and 24-week assessments including fitness testing, blood tests, body composition, surveys, and wearable activity monitoring.

Experimental Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-29 years
  • Currently enrolled undergraduate or graduate student
  • Body mass index (BMI) ≥25.0 kg/m² (classified as overweight or obese)
  • Self-report of engaging in \<150 minutes per week of moderate-to-vigorous physical activity
  • Able and willing to safely ride a bicycle for commuting or transportation purposes
  • Willing to be randomized and complete all study procedures across 24 weeks Able to provide informed consent

You may not qualify if:

  • Current use of a bicycle or e-bike for commuting ≥2 times per week
  • Known cardiovascular, metabolic, or orthopedic conditions that limit physical activity or make exercise testing unsafe
  • Currently pregnant, planning pregnancy during the study period, or less than 6 months postpartum
  • Use of medications known to affect glucose metabolism, heart rate, or physical activity (e.g., beta-blockers, insulin)
  • Diagnosed severe mental health disorders that would impair study participation
  • Participation in another clinical trial or lifestyle intervention within the past 3 months
  • Inability or unwillingness to attend lab visits or comply with the intervention protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin-River Falls

River Falls, Wisconsin, 54022, United States

Location

Related Publications (4)

  • Peterman JE, Morris KL, Kram R, Byrnes WC. Pedelecs as a physically active transportation mode. Eur J Appl Physiol. 2016 Aug;116(8):1565-73. doi: 10.1007/s00421-016-3408-9. Epub 2016 Jun 14.

    PMID: 27299435BACKGROUND
  • Berntsen S, Malnes L, Langaker A, Bere E. Physical activity when riding an electric assisted bicycle. Int J Behav Nutr Phys Act. 2017 Apr 26;14(1):55. doi: 10.1186/s12966-017-0513-z.

    PMID: 28446180BACKGROUND
  • Johnson L, O'Hara BJ, Phongsavan P, et al. Exploring the feasibility of a 6-week electric-bike intervention with behavioural support in Australia. International Journal of Environmental Research and Public Health. 2021;18(16):8684

    BACKGROUND
  • Bourne JE, Sauchelli S, Perry R, Page A, Leary S, England C, Cooper AR. Health benefits of electrically-assisted cycling: a systematic review. Int J Behav Nutr Phys Act. 2018 Nov 21;15(1):116. doi: 10.1186/s12966-018-0751-8.

    PMID: 30463581BACKGROUND

MeSH Terms

Conditions

ObesityOverweightSedentary BehaviorHealth BehaviorMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Gregory Ruegsegger, PhD

    University of Wisconsin, River Falls

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 4, 2025

First Posted

August 11, 2025

Study Start

May 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) collected in this study-including demographic information, outcome measures (e.g., physical activity, VO₂peak, body composition, survey scores), and visit-level data-will be made available to qualified researchers upon reasonable request. Data will be shared in a manner that protects participant confidentiality and complies with IRB and institutional policies.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be available beginning 12 months after study completion and for up to 5 years thereafter.
Access Criteria
Researchers must submit a data use request, including a brief study proposal and data security plan, to the study principal investigator. Requests will be reviewed by the research team for scientific merit and feasibility. Approved researchers will be provided with a de-identified dataset via a secure, password-protected data repository.

Locations