Telenutrition Weight Loss Study for Men
- Conditions
- ObesityMenWeight Loss
- Interventions
- Behavioral: Registered Dietitian Nutritionist (RDN) SupportBehavioral: Self-monitoring toolsBehavioral: Diet-related educational materials
- Registration Number
- NCT02938897
- Lead Sponsor
- West Virginia University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enhanced Usual Care Control Self-monitoring tools Participants receive diet-related educational materials and self-monitoring tools. Telenutrition Intervention Registered Dietitian Nutritionist (RDN) Support Participants receive diet-related educational materials and self-monitoring tools PLUS registered dietitian nutritionist support. Telenutrition Intervention Self-monitoring tools Participants receive diet-related educational materials and self-monitoring tools PLUS registered dietitian nutritionist support. Telenutrition Intervention Diet-related educational materials Participants receive diet-related educational materials and self-monitoring tools PLUS registered dietitian nutritionist support. Enhanced Usual Care Control Diet-related educational materials Participants receive diet-related educational materials and self-monitoring tools.
- Primary Outcome Measures
Name Time Method Change in Weight Baseline to 12 weeks
- Secondary Outcome Measures
Name Time Method Program Usefulness 6 and 12 Weeks Questionnaire
Health Related Quality of Life Baseline and 12 Weeks HRQOL-4
Program Satisfaction 6 and 12 Weeks Questionnaire
Change in Body Composition Baseline to 6 and 12 Weeks Bioelectrical impedance analysis
Change in Caloric Intake Baseline to 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 4-day food records, Healthy Eating Index-2010.