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

NCT ID: NCT02482922

Last Updated: 2017-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-01-31

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.

Conditions

Pre-Diabetic; Overweight; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

IET and Nutrition

3 times per week of interval exercise training Once daily meal replacement

Group Type: EXPERIMENTAL

Exercise & Dietary Supplement

Intervention Type: OTHER

Interventions

Exercise & Dietary Supplement

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Abbie Smith-Ryan, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abbie Smith-Ryan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

University of North Carolina Family Medicine Center

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34337406 (View on PubMed)

Other Identifiers

13-3515

Identifier Type: -

Identifier Source: org_study_id