Telenutrition Weight Loss Study for Men
17. oktober 2016 opdateret af: Melissa Ventura-Marra, West Virginia University
A Pilot Randomized Controlled Trial of a Home Telenutrition Weight Loss Program in 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.
Studieoversigt
Status
Afsluttet
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Telenutrition Intervention
Participants receive diet-related educational materials and self-monitoring tools PLUS registered dietitian nutritionist 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.
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 including: weekly weight log, fruit and vegetable tracker, and a SMART (specific, measurable, achievable, relevant, and time bound) goal planner were provided.
|
|
Aktiv komparator: Enhanced Usual Care Control
Participants receive diet-related educational materials and self-monitoring tools.
|
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 including: weekly weight log, fruit and vegetable tracker, and a SMART (specific, measurable, achievable, relevant, and time bound) goal planner were provided.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in Weight
Tidsramme: Baseline to 12 weeks
|
Baseline to 12 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Waist Circumference
Tidsramme: Baseline to 6 and 12 weeks
|
Baseline to 6 and 12 weeks
|
|
|
Change in Caloric Intake
Tidsramme: Baseline to 6 and 12 Weeks
|
Baseline to 6 and 12 Weeks
|
|
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Change in Diet and Diet Quality
Tidsramme: Baseline to 6 and 12 Weeks
|
4-day food records, Healthy Eating Index-2010.
|
Baseline to 6 and 12 Weeks
|
|
Change in Body Composition
Tidsramme: Baseline to 6 and 12 Weeks
|
Bioelectrical impedance analysis
|
Baseline to 6 and 12 Weeks
|
|
Health Related Quality of Life
Tidsramme: Baseline and 12 Weeks
|
HRQOL-4
|
Baseline and 12 Weeks
|
|
Program Satisfaction
Tidsramme: 6 and 12 Weeks
|
Questionnaire
|
6 and 12 Weeks
|
|
Program Usefulness
Tidsramme: 6 and 12 Weeks
|
Questionnaire
|
6 and 12 Weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Melissa D Ventura-Marra, PhD, West Virginia University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2016
Primær færdiggørelse (Faktiske)
1. maj 2016
Studieafslutning (Faktiske)
1. juni 2016
Datoer for studieregistrering
Først indsendt
25. september 2016
Først indsendt, der opfyldte QC-kriterier
17. oktober 2016
Først opslået (Skøn)
19. oktober 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
19. oktober 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. oktober 2016
Sidst verificeret
1. oktober 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1501549080
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Data will only be reported in aggregate.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .