Clinical trial NCT02482922: Feasibility of an Interval Exercise and Nutrition Intervention to Reduce Cardiovascular Disease Risk Factors
Official title: Feasibility of an Interval Exercise and Nutrition Intervention to Reduce Cardiovascular Disease Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Diabetic
Overweight
Obesity
Keywords: feasibility studies
intervention
Pre-Hypertensive
Pre-Hyperlipidemia
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2015-06-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Number of participants that complete exercise program
timeFrame: 3 months
measure: Number of participants that complete nutrition program
timeFrame: 3 months
measure: Number of exercise sessions completed
timeFrame: 3 months
measure: Number of days nutrition program followed
timeFrame: 3 months
Secondary outcomes:
measure: Change in Cardiorespiratory Fitness at 3 months, 6 months, and 12 months
timeFrame: 3 months, 6 months, 12 months
measure: Change in fat mass at 3 months, 6 months, and 12 months
timeFrame: 3 months, 6 months, 12 months
measure: Change in lean mass at 3 months, 6 months, and 12 months
timeFrame: 3 months, 6 months, 12 months
measure: Change in blood lipids at 3 months, 6 months, 12 months
timeFrame: 3 months, 6 months, 12 months
measure: Change in hemoglobin A1c at 3 months, 6 months, 12 months
timeFrame: 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Family Medicine Center
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Abbie Smith-Ryan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.