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

NCT02482922 | Completed

• 1 other identifier: 13-3515
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

feasibility studies; intervention; Pre-Hypertensive; Pre-Hyperlipidemia

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• 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

Study Arms (1)

IET and Nutrition

EXPERIMENTAL

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

Other: Exercise & Dietary Supplement

Interventions

Exercise & Dietary Supplement OTHER

IET and Nutrition

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina Family Medicine Center

Chapel Hill, North Carolina, United States

Location

Related Publications (1)

• 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.

  PMID: 34337406 DERIVED

MeSH Terms

Conditions

Glucose Intolerance; Overweight; Obesity

Interventions

Exercise; Dietary Supplements

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Abbie Smith-Ryan, PhD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: June 26, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: January 1, 2017
• Last Updated: April 14, 2017

Record last verified: 2017-04

Locations

US (1)