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Completed

NCT Number: NCT02482922

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina Family Medicine Center

Chapel Hill, North Carolina, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

  • 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.

Treatment and study plan

Exercise & Dietary Supplement

Other

Primary outcomes

  1. Number of participants that complete exercise program

    Time frame: 3 months

  2. Number of participants that complete nutrition program

    Time frame: 3 months

  3. Number of exercise sessions completed

    Time frame: 3 months

  4. Number of days nutrition program followed

    Time frame: 3 months

Secondary outcomes

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

    Time frame: 3 months, 6 months, 12 months

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

    Time frame: 3 months, 6 months, 12 months

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

    Time frame: 3 months, 6 months, 12 months

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

    Time frame: 3 months, 6 months, 12 months

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

    Time frame: 3 months, 6 months, 12 months

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

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

Acronym: IETnutrition

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 26, 2015
Registry last updated
Apr 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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