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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Pre-Diabetic
• Intervention / Treatment: Other: Exercise & Dietary Supplement

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States
      • University of North Carolina Family Medicine Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants that complete exercise program	3 months
Number of participants that complete nutrition program	3 months
Number of exercise sessions completed	3 months
Number of days nutrition program followed	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Cardiorespiratory Fitness at 3 months, 6 months, and 12 months	3 months, 6 months, 12 months
Change in fat mass at 3 months, 6 months, and 12 months	3 months, 6 months, 12 months
Change in lean mass at 3 months, 6 months, and 12 months	3 months, 6 months, 12 months
Change in blood lipids at 3 months, 6 months, 12 months	3 months, 6 months, 12 months
Change in hemoglobin A1c at 3 months, 6 months, 12 months	3 months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Abbie Smith-Ryan, PhD, University of North Carolina

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: June 22, 2015
• First Submitted That Met QC Criteria: June 25, 2015
• First Posted (Estimate): June 26, 2015

Study Record Updates

• Last Update Posted (Actual): April 14, 2017
• Last Update Submitted That Met QC Criteria: April 13, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: intervention; feasibility studies; Pre-Hypertensive; Pre-Hyperlipidemia
• Additional Relevant MeSH Terms: Body Weight; Cardiovascular Diseases; Overweight
• Other Study ID Numbers: 13-3515