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Telenutrition Weight Loss Study for Men

Primary Purpose

Obesity, Weight Loss, Men

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Registered Dietitian Nutritionist (RDN) Support

Diet-related educational materials

Self-monitoring tools

About this trial

This is an interventional treatment trial for Obesity focused on measuring Telehealth, Weight loss, Diet quality, Behavioral counseling

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)MaleAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telenutrition Intervention

Enhanced Usual Care Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Weight

Secondary Outcome Measures

Change in Waist Circumference

Change in Caloric Intake

Change in Diet and Diet Quality

4-day food records, Healthy Eating Index-2010.

Change in Body Composition

Bioelectrical impedance analysis

Health Related Quality of Life

HRQOL-4

Program Satisfaction

Questionnaire

Program Usefulness

Questionnaire

Full Information

NCT ID

NCT02938897

First Posted

September 25, 2016

Last Updated

October 17, 2016

Sponsor

West Virginia University

1. Study Identification

Unique Protocol Identification Number

NCT02938897

Brief Title

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

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

January 2016 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

West Virginia University

4. Oversight

Data Monitoring Committee

5. Study Description

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: To assess the feasibility and acceptability of the male-targeted telenutrition weight loss program in terms of recruitment, retention and satisfaction and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Weight Loss, Men

Keywords

Telehealth, Weight loss, Diet quality, Behavioral counseling

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Telenutrition Intervention

Arm Type

Experimental

Arm Description

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

Arm Title

Enhanced Usual Care Control

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Registered Dietitian Nutritionist (RDN) Support

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Diet-related educational materials

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Self-monitoring tools

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Weight

Time Frame

Baseline to 12 weeks

Secondary Outcome Measure Information:

Title

Change in Waist Circumference

Time Frame

Baseline to 6 and 12 weeks

Title

Change in Caloric Intake

Time Frame

Baseline to 6 and 12 Weeks

Title

Change in Diet and Diet Quality

Description

4-day food records, Healthy Eating Index-2010.

Time Frame

Baseline to 6 and 12 Weeks

Title

Change in Body Composition

Description

Bioelectrical impedance analysis

Time Frame

Baseline to 6 and 12 Weeks

Title

Health Related Quality of Life

Description

HRQOL-4

Time Frame

Baseline and 12 Weeks

Title

Program Satisfaction

Description

Questionnaire

Time Frame

6 and 12 Weeks

Title

Program Usefulness

Description

Questionnaire

Time Frame

6 and 12 Weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Melissa D Ventura-Marra, PhD

Organizational Affiliation

West Virginia University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Data will only be reported in aggregate.

Learn more about this trial

Telenutrition Weight Loss Study for Men

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