Telenutrition Weight Loss Study for Men

Obesity Clinical Trial

Official title:

A Pilot Randomized Controlled Trial of a Home Telenutrition Weight Loss Program in Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02938897
• Other study ID #: 1501549080
• Status: Completed
• Phase: N/A
• First received: September 25, 2016
• Last updated: October 17, 2016
• Start date: January 2016
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Men
• Obesity
• Weight Loss

Intervention

Behavioral:
• Registered 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.
• Diet-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.
• Self-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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight		Baseline to 12 weeks	No
Secondary	Change in Waist Circumference		Baseline to 6 and 12 weeks	No
Secondary	Change in Caloric Intake		Baseline to 6 and 12 Weeks	No
Secondary	Change in Diet and Diet Quality	4-day food records, Healthy Eating Index-2010.	Baseline to 6 and 12 Weeks	No
Secondary	Change in Body Composition	Bioelectrical impedance analysis	Baseline to 6 and 12 Weeks	No
Secondary	Health Related Quality of Life	HRQOL-4	Baseline and 12 Weeks	No
Secondary	Program Satisfaction	Questionnaire	6 and 12 Weeks	No
Secondary	Program Usefulness	Questionnaire	6 and 12 Weeks	No