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Completed

NCT Number: NCT02938897

Telenutrition Weight Loss Study for 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Registered Dietitian Nutritionist (RDN) Support

Behavioral

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

Behavioral

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

Behavioral

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 outcomes

  1. Change in Weight

    Time frame: Baseline to 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 19, 2016
Registry last updated
Oct 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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