NCT03227575

Brief Summary

Physical activity is shown to positively reduce the risk of developing both cardiovascular disease and type 2 diabetes. Current guidelines recommend 30-60 minutes of moderate intensity cardiorespiratory exercise five days per week. However, studies report that \<40% of young adults 18-24 years achieve the recommended weekly physical activity guidelines, and close to 40% of young adults are overweight or obese. Traditional aerobic exercise and high intensity exercise have been shown to improve glycemic control in young and middle-aged sedentary adults, however, long term implementation of such exercise regimens are difficult. Recent evidence suggests that short bouts (15 minutes) of moderate intensity walking following a meal, significantly improves glycemic control in older adults with impaired glucose control. Due to the low burden of walking on participants, moderate intensity post-meal walking might be a better alternative exercise intervention to improve overall health in a sedentary population. Therefore, the purpose of this pilot proposal is to determine if 15 minutes of post-meal walking is an effective intervention to improve glycemic control in sedentary young adults at risk for developing MetS. Additionally, the study will investigate whether ambulatory blood pressure profiles in obese young adults are disrupted.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 7, 2017

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2024

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

7.2 years

First QC Date

June 28, 2017

Last Update Submit

November 8, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Determine whether ambulatory blood glucose control responses are improved following 28 days of exercise training (Post Training).

    Examine blood glucose (mg/dL) responses during two oral glucose tolerance test (70g glucose drink). The first test will be measured at baseline (Base) and the second test will be measured following 28 days of exercise training. These two tests (Base vs Post Training) will be separated by an average of 32 days.

    An average of 32 days will separate these two measurements.

  • Determine whether serum insulin (IU/mL) responses are improved following 28 days of exercise training (Post Training).

    Examine serum insulin (IU/mL) responses during two oral glucose tolerance tests (70g glucose drink). The first test will be measured at baseline (Base) and the second test will be measured following 28 days of exercise training. These two tests (Base vs Post Training) will be separated by an average of 32 days.

    An average of 32 days will separate these two measurements.

Secondary Outcomes (1)

  • Determine whether ambulatory blood pressure profiles are different following an average of 28 day exercise intervention compared to sedentary healthy controls.

    An average of 28 days will separate these two measurements.

Study Arms (3)

Post-Meal Walking Group

EXPERIMENTAL

Following a 30-minute digestion period, the Post-Meal Walking Group will be instructed to walk following breakfast, lunch, and dinner at least 4 times per week (180 minutes of moderate intensity exercise/week). Participants will walk at a brisk pace for 15 minutes, as demonstrated in a previous study. A Garmin VivoFit activity monitor will measure their physical activity across the four-week intervention. The Garmin VivoFit activity monitor must be returned during the "Follow-up Study Visit".

Behavioral: Exercise Intervention

Traditional Exercise Group

EXPERIMENTAL

The Traditional Exercise Group will perform aerobic and light resistance training exercise over the 4-week intervention. A group of trained Exercise and Sports Physiology students will conduct the aerobic exercise and light resistance training program three times per week (180 minutes of moderate to high intensity exercise/week). Garmin VivoFit activity monitors will measure their physical activity across the four-week intervention. The Garmin VivoFit activity monitor must be returned during the "Follow-up Study Visit".

Behavioral: Exercise Intervention

Case Control Group

NO INTERVENTION

The participant will be instructed to maintain their current diet and levels of physical activity for four weeks. Participants in this group will wear an ambulatory blood pressure monitor at baseline and at follow-up. Any change in diet and physical activity level might significantly affect the study results. The Control Group will maintain their current lifestyle for four weeks. Garmin VivoFit activity monitors will measure their physical activity throughout the 4-week intervention. The Garmin VivoFit activity monitor must be returned during the "Follow-up Study Visit".

Interventions

The use of exercise to improve glycemic responses in young adults who are at risk for Metabolic Syndrome.

Post-Meal Walking GroupTraditional Exercise Group

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index ≥ 30
  • Currently not physically active
  • Free of any signs and symptoms of cardiovascular disease, diabetes, chronic kidney disease, and cancer.

You may not qualify if:

  • Planning to become pregnant
  • Any known signs and symptoms of cardiovascular disease, diabetes, chronic kidney disease, and cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Draper & Maynard

Plymouth, New Hampshire, 03264, United States

Location

Plymouth State University

Plymouth, New Hampshire, 03264, United States

Location

MeSH Terms

Conditions

Metabolic SyndromeObesity

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2017

First Posted

July 24, 2017

Study Start

September 7, 2017

Primary Completion

November 8, 2024

Study Completion

November 8, 2024

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations