Clinical trial NCT02938897: Telenutrition Weight Loss Study for Men
Official title: A Pilot Randomized Controlled Trial of a Home Telenutrition Weight Loss Program in Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
Men
Keywords: Telehealth
Weight loss
Diet quality
Behavioral counseling
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 60
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Weight
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change in Waist Circumference
timeFrame: Baseline to 6 and 12 weeks
measure: Change in Caloric Intake
timeFrame: Baseline to 6 and 12 Weeks
measure: Change in Diet and Diet Quality
timeFrame: Baseline to 6 and 12 Weeks
measure: Change in Body Composition
timeFrame: Baseline to 6 and 12 Weeks
measure: Health Related Quality of Life
timeFrame: Baseline and 12 Weeks
measure: Program Satisfaction
timeFrame: 6 and 12 Weeks
measure: Program Usefulness
timeFrame: 6 and 12 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: West Virginia University
name: Melissa D Ventura-Marra, PhD
role: PRINCIPAL_INVESTIGATOR
References: