Telenutrition Weight Loss Study for Men

West Virginia University

Status: Completed

Conditions: Weight Loss; Men; Obesity

Treatments: Behavioral: Registered Dietitian Nutritionist (RDN) Support; Behavioral: Self-monitoring tools; Behavioral: Diet-related educational materials

Study type: Interventional

Funder types: Other

Identifiers

NCT02938897

1501549080

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Male

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Telenutrition Intervention

Experimental group

Description:

Participants receive diet-related educational materials and self-monitoring tools PLUS registered dietitian nutritionist support.

Treatment:

Behavioral: Self-monitoring tools

Behavioral: Diet-related educational materials

Behavioral: Registered Dietitian Nutritionist (RDN) Support

Enhanced Usual Care Control

Active Comparator group

Description:

Participants receive diet-related educational materials and self-monitoring tools.

Treatment:

Behavioral: Self-monitoring tools

Behavioral: Diet-related educational materials