AzTrials
AzTrials

Pre-DiabeticIETnutritionNCT02482922

Feasibility of an Interval Exercise and Nutrition Intervention to Reduce Cardiovascular Disease Risk Factors

A study testing Exercise & Dietary Supplement in people with Pre-Diabetic and Overweight, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Purpose : Test the feasibility (acceptability, adherence) of a home-based interval exercise training (IET) and nutrition program, as well as its preliminary effects on resting heart rate, blood pressure, fasting glucose, HDL, cholesterol, weight and percent body fat, among primary care patients who have at least one… Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Pre-Diabetic, Overweight, Obesity
What is being tested?
Exercise & Dietary Supplement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
May 2015to Jan 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients are:
  • > 18-85 years;
  • receive primary care in the FMC (> 1 visit during the previous year); and
  • have ≥1 risk factor or developing risk factors for CVD (blood pressure >130/85 mmHG, BMI >25 kg/m2(or ~20 lbs overweight), Fasting glucose >110 mg/dl, OR 4) HDL <30) (all identified via medical record)

Who cannot join

  • those for whom exercise and/or diet are contraindicated (e.g., scheduled for arthroplasty) or who are at risk of death in the next year (e.g., Class IV heart failure, end-stage renal disease).
  • those taking medication for diabetes, blood pressure, and lipids for more than 2 years.
  • pregnant or planning on becoming pregnant within the next year.
  • Allergic to any ingredient in the nutritional meal replacement.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of North Carolina Family Medicine Center

    Chapel Hill, North Carolina

Other trials in United States

About this study

Official title: Feasibility of an Interval Exercise and Nutrition Intervention to Reduce Cardiovascular Disease Risk

Purpose : Test the feasibility (acceptability, adherence) of a home-based interval exercise training (IET) and nutrition program, as well as its preliminary effects on resting heart rate, blood pressure, fasting glucose, HDL, cholesterol, weight and percent body fat, among primary care patients who have at least one risk factor for cardiovascular disease (CVD).

Participants : 30 patients who receive care from the University of North Carolina (UNC) Family Medicine Center (FMC) and meet the inclusion criteria defined below (i.e. general FMC patients, not diagnosed with severe illness), will be enrolled to test the feasibility of the home-based interval exercise and nutrition program.

Procedures (methods): A home-based IET and nutrition program will be piloted in 2 phases. In Phase I, 15 patients will be enrolled into the program, which will take approximately 3 months. At baseline, data will be collected on age, height, weight, resting heart rate, blood pressure, fasting glucose, hemoglobin A1c, fasting lipids, cholesterol, insulin, percent body fat, cardiovascular fitness, and use a series of questionnaires to evaluate mood, sleep, hunger, and quality of life. At closeout, the investigators will measure patients' adherence to each component of the intervention. In Phase II, an additional 15 new patients will be enrolled in either the identical protocol, or a slightly modified intervention (if necessary based upon our results from Phase I). All patients will have the same variables measured at baseline during their study visit at 3, 6 and 12 months after enrollment into the study.

Being tested
Exercise & Dietary Supplement
Keywords
feasibility studies, intervention, Pre-Hypertensive, Pre-Hyperlipidemia
Medical subject headings
Glucose Intolerance, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise & Dietary SupplementOther

Study groups in NCT02482922
Study groupRoleWhat they receive
IET and NutritionExperimental3 times per week of interval exercise training Once daily meal replacement
Receives: Other: Exercise & Dietary Supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants that complete exercise program

    Measured: 3 months

  2. Number of participants that complete nutrition program

    Measured: 3 months

  3. Number of exercise sessions completed

    Measured: 3 months

  4. Number of days nutrition program followed

    Measured: 3 months

Secondary outcomes (5)

  1. Change in Cardiorespiratory Fitness at 3 months, 6 months, and 12 months

    Measured: 3 months, 6 months, 12 months

  2. Change in fat mass at 3 months, 6 months, and 12 months

    Measured: 3 months, 6 months, 12 months

  3. Change in lean mass at 3 months, 6 months, and 12 months

    Measured: 3 months, 6 months, 12 months

  4. Change in blood lipids at 3 months, 6 months, 12 months

    Measured: 3 months, 6 months, 12 months

  5. Change in hemoglobin A1c at 3 months, 6 months, 12 months

    Measured: 3 months, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionMay 2016
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02482922
Sponsor's protocol ID
13-3515
Acronym
IETnutrition
Status last verified
Apr 2017
First submitted
22 Jun 2015
Last updated
14 Apr 2017
Results posted
No
Data monitoring committee
No

Publications

  • Smith-Ryan AE, Weaver MA, Viera AJ, Weinberger M, Blue MNM, Hirsch KR. Promoting Exercise and Healthy Diet Among Primary Care Patients: Feasibility, Preliminary Outcomes, and Lessons Learned From a Pilot Trial With High Intensity Interval Exercise. Front Sports Act Living. 2021 Jul 16;3:690243. doi: 10.3389/fspor.2021.690243. eCollection 2021.

    PubMed 34337406

Questions about this trial

What is this clinical trial studying?

A study testing Exercise & Dietary Supplement in people with Pre-Diabetic and Overweight, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants that complete exercise program (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02482922, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in