Telenutrition Weight Loss Study for Men

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Loss; Men
• Intervention / Treatment: Behavioral: Registered Dietitian Nutritionist (RDN) Support; Behavioral: Diet-related educational materials; Behavioral: Self-monitoring tools

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telenutrition Intervention; Participants receive diet-related educational materials and self-monitoring tools PLUS registered dietitian nutritionist support.	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.; Behavioral: 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.; Behavioral: 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.
Active Comparator: Enhanced Usual Care Control; Participants receive diet-related educational materials and self-monitoring tools.	Behavioral: 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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Weight	Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Waist Circumference		Baseline to 6 and 12 weeks
Change in Caloric Intake		Baseline to 6 and 12 Weeks
Change in Diet and Diet Quality	4-day food records, Healthy Eating Index-2010.	Baseline to 6 and 12 Weeks
Change in Body Composition	Bioelectrical impedance analysis	Baseline to 6 and 12 Weeks
Health Related Quality of Life	HRQOL-4	Baseline and 12 Weeks
Program Satisfaction	Questionnaire	6 and 12 Weeks
Program Usefulness	Questionnaire	6 and 12 Weeks

Collaborators and Investigators

• Sponsor: West Virginia University
• Investigators: Principal Investigator: Melissa D Ventura-Marra, PhD, West Virginia University

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: September 25, 2016
• First Submitted That Met QC Criteria: October 17, 2016
• First Posted (Estimate): October 19, 2016

Study Record Updates

• Last Update Posted (Estimate): October 19, 2016
• Last Update Submitted That Met QC Criteria: October 17, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Weight loss; Telehealth; Diet quality; Behavioral counseling
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: 1501549080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will only be reported in aggregate.