Telenutrition Weight Loss Study for Men

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Weight Loss, Men

Intervention / Treatment
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* Behavioral: Registered Dietitian Nutritionist (RDN) Support
* Behavioral: Diet-related educational materials
* Behavioral: Self-monitoring tools


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telenutrition Intervention<br>Participants receive diet-related educational materials and self-monitoring tools PLUS registered dietitian nutritionist support. | Behavioral: Registered Dietitian Nutritionist (RDN) Support<br>* 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.<br>Behavioral: Diet-related educational materials<br>* 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.<br>Behavioral: Self-monitoring tools<br>* 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.<br>|
| Active Comparator: Enhanced Usual Care Control<br>Participants receive diet-related educational materials and self-monitoring tools. | Behavioral: Diet-related educational materials<br>* 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.<br>Behavioral: Self-monitoring tools<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telehealth, Weight loss, Diet quality, Behavioral counseling