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

Primary Purpose

Pre-Diabetic, Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise & Dietary Supplement
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pre-Diabetic focused on measuring feasibility studies, intervention, Pre-Hypertensive, Pre-Hyperlipidemia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of North Carolina Family Medicine Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IET and Nutrition

Arm Description

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

Outcomes

Primary Outcome Measures

Number of participants that complete exercise program
Number of participants that complete nutrition program
Number of exercise sessions completed
Number of days nutrition program followed

Secondary Outcome Measures

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

Full Information

First Posted
June 22, 2015
Last Updated
April 13, 2017
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT02482922
Brief Title
Feasibility of an Interval Exercise and Nutrition Intervention to Reduce Cardiovascular Disease Risk Factors
Acronym
IETnutrition
Official Title
Feasibility of an Interval Exercise and Nutrition Intervention to Reduce Cardiovascular Disease Risk
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Diabetic, Overweight, Obesity
Keywords
feasibility studies, intervention, Pre-Hypertensive, Pre-Hyperlipidemia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IET and Nutrition
Arm Type
Experimental
Arm Description
3 times per week of interval exercise training Once daily meal replacement
Intervention Type
Other
Intervention Name(s)
Exercise & Dietary Supplement
Primary Outcome Measure Information:
Title
Number of participants that complete exercise program
Time Frame
3 months
Title
Number of participants that complete nutrition program
Time Frame
3 months
Title
Number of exercise sessions completed
Time Frame
3 months
Title
Number of days nutrition program followed
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in Cardiorespiratory Fitness at 3 months, 6 months, and 12 months
Time Frame
3 months, 6 months, 12 months
Title
Change in fat mass at 3 months, 6 months, and 12 months
Time Frame
3 months, 6 months, 12 months
Title
Change in lean mass at 3 months, 6 months, and 12 months
Time Frame
3 months, 6 months, 12 months
Title
Change in blood lipids at 3 months, 6 months, 12 months
Time Frame
3 months, 6 months, 12 months
Title
Change in hemoglobin A1c at 3 months, 6 months, 12 months
Time Frame
3 months, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abbie Smith-Ryan, PhD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina Family Medicine Center
City
Chapel Hill
State/Province
North Carolina
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34337406
Citation
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.
Results Reference
derived

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

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