Timing Intervention of Morning Versus Evening Exercise

NCT05153252 | Recruiting

• 2 other identifiers: 21-30941R01DK126814-01A1
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are doing this study to learn more about how exercising at different times of the day (morning versus evening) affects body weight, sleep, eating patterns, and other factors.

Conditions

Overweight and Obesity

Keywords

Overweight; Obesity; Exercise

Outcome Measures

Primary Outcomes (1)

• Weight Change (kg)

  Body weight will be measured using a digital scale at baseline, 3.5, 7, and 13 months. The primary outcome will be change in weight from baseline to 7 months.

  Baseline (0) - 13 Months

Secondary Outcomes (9)

• Fat Mass

  Baseline (0) - 13 Months

• Lean Mass

  Baseline (0) - 13 Months

• Energy Intake

  Baseline (0) - 7 Months

• Total Daily Energy Expenditure

  Baseline (0) - 7 Months

• Hunger and Satiety

  Baseline (0) - 13 Months

Study Arms (2)

Morning Exercise (AM)

EXPERIMENTAL

Participants in this group will be prescribed morning aerobic exercise.

Behavioral: Morning Exercise

Evening Exercise (PM)

EXPERIMENTAL

Participants in this group will be prescribed evening aerobic exercise.

Behavioral: Evening Exercise

Interventions

Morning Exercise BEHAVIORAL

Morning Exercise will be instructed to perform 2000 kcal/wk of moderate to vigorous intensity aerobic exercise between the hours of 6 and 10 AM.

Also known as: AM Exercise, AM-EX

Morning Exercise (AM)

Evening Exercise BEHAVIORAL

PM will be instructed to perform 2000 kcal/wk of moderate to vigorous intensity aerobic exercise between the hours of 3 and 7 PM.

Also known as: PM Exercise, PM-EX

Evening Exercise (PM)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female or Male
• Age 18-55 years
• Body Mass Index 25-40 kg/m2
• Physically inactive: defined as self-reporting \<150 minutes per week of physical activity at moderate intensity or greater on a regular basis over the past 3 months.
• No self-report of acute or chronic disease (cardiovascular disease (CVD), diabetes, gastrointestinal disorders and orthopedic problems in particular)
• No plans to relocate within the next 15 months.
• No plans for extended travel (\> 2 weeks) within the next 13 months
• Live or work within 30 minutes of the Anschutz Health \& Wellness Center (AHWC) (exceptions may be made at the discretion of the Study PI on a case-by-case basis for highly motivated subjects).

You may not qualify if:

• No contraindications to exercise or limitations on ability to be physically active.
• Willing to be randomized to either AM or PM exercise and complete 4 exercise sessions per week.
• Own a smart phone and willing to download and use text messaging for meal intake and other related assessments.
• Willing and able to wear activity/sleep monitor for 7-14 consecutive days.
• Willing not to enroll in any other formal weight loss or physical activity programs over the next 13 months.
• Fully vaccinated, or willing to be fully vaccinated, against COVID-19 prior to study enrollment (fully vaccinated is defined as at least 2 weeks post final vaccine dose).
• Have a primary care physician (or are willing to establish care with a primary care physician prior to study enrollment) to address medical issues which may arise during screening or study procedures/interventions.
• For Females
• Not currently pregnant or lactating
• Not pregnant within the past 6 months
• Not planning to become pregnant in the next 15 months; sexually active women of childbearing potential may be enrolled if they have had a tubal ligation or use a reliable means of contraception
• Diastolic blood pressure \> 100 mm HG or systolic blood pressure \> 160 mm HG.
• Resting heart rate \>100
• Diabetes (fasting glucose ≥126 mg/dL or Hemoglobin A1C ≥6.5%)
• Undiagnosed hypo- or hyper-thyroidism (Thyroid Stimulating Hormone (TSH) outside of the normal range) or history of uncontrolled thyroid disorder. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 6 months is acceptable.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Vicki Catenacci

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liza Wayland

CONTACT

303-724-9096; liza.wayland@cuanschutz.edu

Kristen Bing

CONTACT

303-724-9098; kristen.bing@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 10, 2021
• Study Start: December 7, 2021
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)