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Telenutrition Weight Loss Study for Men

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ClinicalTrials.gov Identifier: NCT02938897
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
Melissa Ventura-Marra, West Virginia University

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.

Condition or disease Intervention/treatment Phase
Obesity Weight Loss Men Behavioral: Registered Dietitian Nutritionist (RDN) Support Behavioral: Diet-related educational materials Behavioral: Self-monitoring tools Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Randomized Controlled Trial of a Home Telenutrition Weight Loss Program in Men
Study Start Date : January 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in Weight [ Time Frame: Baseline to 12 weeks ]

Secondary Outcome Measures :
  1. Change in Waist Circumference [ Time Frame: Baseline to 6 and 12 weeks ]
  2. Change in Caloric Intake [ Time Frame: Baseline to 6 and 12 Weeks ]
  3. Change in Diet and Diet Quality [ Time Frame: Baseline to 6 and 12 Weeks ]
    4-day food records, Healthy Eating Index-2010.

  4. Change in Body Composition [ Time Frame: Baseline to 6 and 12 Weeks ]
    Bioelectrical impedance analysis

  5. Health Related Quality of Life [ Time Frame: Baseline and 12 Weeks ]
    HRQOL-4

  6. Program Satisfaction [ Time Frame: 6 and 12 Weeks ]
    Questionnaire

  7. Program Usefulness [ Time Frame: 6 and 12 Weeks ]
    Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938897


Sponsors and Collaborators
West Virginia University
Investigators
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Principal Investigator: Melissa D Ventura-Marra, PhD West Virginia University

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Responsible Party: Melissa Ventura-Marra, Assistant Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT02938897     History of Changes
Other Study ID Numbers: 1501549080
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will only be reported in aggregate.

Keywords provided by Melissa Ventura-Marra, West Virginia University:
Telehealth
Weight loss
Diet quality
Behavioral counseling

Additional relevant MeSH terms:
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Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes