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

Obesity Clinical Trial

— IETnutrition  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02482922
• Other study ID #: 13-3515
• Status: Completed
• Phase: N/A
• First received: June 22, 2015
• Last updated: April 13, 2017
• Start date: May 2015
• Est. completion date: January 2017

Study information

• Verified date: April 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Obesity
• Overweight
• Pre-Diabetic
• Prediabetic State

Intervention

Other:
• Exercise & Dietary Supplement

Locations

Country	Name	City	State
United States	University of North Carolina Family Medicine Center	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants that complete exercise program		3 months
Primary	Number of participants that complete nutrition program		3 months
Primary	Number of exercise sessions completed		3 months
Primary	Number of days nutrition program followed		3 months
Secondary	Change in Cardiorespiratory Fitness at 3 months, 6 months, and 12 months		3 months, 6 months, 12 months
Secondary	Change in fat mass at 3 months, 6 months, and 12 months		3 months, 6 months, 12 months
Secondary	Change in lean mass at 3 months, 6 months, and 12 months		3 months, 6 months, 12 months
Secondary	Change in blood lipids at 3 months, 6 months, 12 months		3 months, 6 months, 12 months
Secondary	Change in hemoglobin A1c at 3 months, 6 months, 12 months		3 months, 6 months, 12 months