Men, Obesity, Weight Loss
Conditions
Keywords
Telehealth, Weight loss, Diet quality, Behavioral counseling
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.
Interventions
BEHAVIORALRegistered Dietitian Nutritionist (RDN) Support
RDN provided individualized medical nutrition therapy via videoconference at weeks 1, 5, and 9 and telephonic nutrition coaching support at weeks 2-4, 6-8, and 10-12.
BEHAVIORALDiet-related educational materials
Individualized caloric recommendations (500-750 kcal reduction) were made and food-based educational materials emphasizing general healthful eating patterns and increased intakes of nutrient-rich foods were provided.
BEHAVIORALSelf-monitoring tools
Self-monitoring tools including: weekly weight log, fruit and vegetable tracker, and a SMART (specific, measurable, achievable, relevant, and time bound) goal planner were provided.
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Weight | Baseline to 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Caloric Intake | 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. |
| Change in Body Composition | Baseline to 6 and 12 Weeks | Bioelectrical impedance analysis |
| Change in Waist Circumference | Baseline to 6 and 12 weeks | — |
| Program Satisfaction | 6 and 12 Weeks | Questionnaire |
| Program Usefulness | 6 and 12 Weeks | Questionnaire |
| Health Related Quality of Life | Baseline and 12 Weeks | HRQOL-4 |
Outcome results
None listed