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

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ClinicalTrials.gov Identifier: NCT02482922
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
Abbie Smith-Ryan, PhD, University of North Carolina, Chapel Hill

Brief 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 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.


Condition or disease Intervention/treatment Phase
Pre-Diabetic Overweight Obesity Other: Exercise & Dietary Supplement Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility of an Interval Exercise and Nutrition Intervention to Reduce Cardiovascular Disease Risk
Study Start Date : May 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IET and Nutrition
3 times per week of interval exercise training Once daily meal replacement
Other: Exercise & Dietary Supplement



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients are:

  1. > 18-85 years;
  2. receive primary care in the FMC (> 1 visit during the previous year); and
  3. 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:

  1. 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).
  2. those taking medication for diabetes, blood pressure, and lipids for more than 2 years.
  3. pregnant or planning on becoming pregnant within the next year.
  4. Allergic to any ingredient in the nutritional meal replacement.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482922


Locations
United States, North Carolina
University of North Carolina Family Medicine Center
Chapel Hill, North Carolina, United States
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Abbie Smith-Ryan, PhD University of North Carolina

Responsible Party: Abbie Smith-Ryan, PhD, Assistant Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02482922     History of Changes
Other Study ID Numbers: 13-3515
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017

Keywords provided by Abbie Smith-Ryan, PhD, University of North Carolina, Chapel Hill:
feasibility studies
intervention
Pre-Hypertensive
Pre-Hyperlipidemia

Additional relevant MeSH terms:
Cardiovascular Diseases
Overweight
Prediabetic State
Body Weight
Signs and Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases