NCT02938897

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
Last Updated

October 19, 2016

Status Verified

October 1, 2016

Enrollment Period

4 months

First QC Date

September 25, 2016

Last Update Submit

October 17, 2016

Conditions

ObesityWeight LossMen

Keywords

TelehealthWeight lossDiet qualityBehavioral counseling

Outcome Measures

Primary Outcomes (1)

  • Change in Weight

    Baseline to 12 weeks

Secondary Outcomes (7)

  • 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

    Baseline to 6 and 12 Weeks

  • Change in Body Composition

    Baseline to 6 and 12 Weeks

  • Health Related Quality of Life

    Baseline and 12 Weeks

  • +2 more secondary outcomes

Study Arms (2)

Telenutrition Intervention

EXPERIMENTAL

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

Behavioral: Registered Dietitian Nutritionist (RDN) SupportBehavioral: Diet-related educational materialsBehavioral: Self-monitoring tools

Enhanced Usual Care Control

ACTIVE COMPARATOR

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

Behavioral: Diet-related educational materialsBehavioral: Self-monitoring tools

Interventions

Registered Dietitian Nutritionist (RDN) SupportBEHAVIORAL

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.

Telenutrition Intervention
Diet-related educational materialsBEHAVIORAL

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.

Enhanced Usual Care ControlTelenutrition Intervention
Self-monitoring toolsBEHAVIORAL

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.

Enhanced Usual Care ControlTelenutrition Intervention

Eligibility Criteria

Age40 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityWeight LossMultiple Endocrine Neoplasia Type 1

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Melissa D Ventura-Marra, PhD

    West Virginia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 25, 2016

First Posted

October 19, 2016

Study Start

January 1, 2016

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

October 19, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Data will only be reported in aggregate.