A Pilot Randomized Controlled Trial of a Home Telenutrition Weight Loss Program in Men
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- West Virginia University
- Enrollment
- 60
- Primary Endpoint
- Change in Weight
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This study is a 12-week pilot randomized controlled trial to test the feasibility and effectiveness of a home telenutrition weight loss program in men in West Virginia.
Detailed Description
This study is a 12-week pilot randomized controlled trial of a home telenutrition weight loss program for men with obesity and at least one additional risk factor for cardiovascular disease. The primary aims are to: 1. To assess the feasibility and acceptability of the male-targeted telenutrition weight loss program in terms of recruitment, retention and satisfaction and 2. To evaluate the effectiveness of the telenutrition program compared to usual care (informational only) with regard to primary and secondary outcome measures at 12 weeks. We hypothesized that men receiving virtual and telephonic support from a registered dietitian nutritionist would have greater weight loss and greater improvements in diet quality than men who were only provided educational materials.
Investigators
Melissa Ventura-Marra
Assistant Professor
West Virginia University
Eligibility Criteria
Inclusion Criteria
- •40-70 year old man
- •Body mass index ≥ 30
- •Living with spouse or companion
- •At least one of the following: hypertension, diabetes, pre-diabetes, hypercholesterolemia or hypertriglyceridemia
- •A home computer with high-speed internet access
- •A telephone for health coach phone calls
Exclusion Criteria
- •Cancer (except skin or prostate), celiac disease, bacterial or viral infections, renal or liver disease (except non-alcoholic fatty liver disease), or condition that prevents fruits and vegetable consumption
- •Major surgery or health event (e.g., stroke, heart attack) in the past six months
- •Taking insulin, anti-obesity medications, steroids (e.g., Prednisone), or warfarin (Coumadin)
- •Pacemaker or defibrillator
- •Currently on a weight loss diet or lost \> 10 pounds in past six months
- •Consume more than two alcoholic beverages daily
Outcomes
Primary Outcomes
Change in Weight
Time Frame: Baseline to 12 weeks
Secondary Outcomes
- Change in Body Composition(Baseline to 6 and 12 Weeks)
- Change in Caloric Intake(Baseline to 6 and 12 Weeks)
- Program Usefulness(6 and 12 Weeks)
- Change in Waist Circumference(Baseline to 6 and 12 weeks)
- Change in Diet and Diet Quality(Baseline to 6 and 12 Weeks)
- Health Related Quality of Life(Baseline and 12 Weeks)
- Program Satisfaction(6 and 12 Weeks)