Telenutrition Weight Loss Study for Men
17. oktober 2016 oppdatert av: 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.
Studieoversikt
Status
Fullført
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
60
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in Weight
Tidsramme: Baseline to 12 weeks
|
Baseline to 12 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Melissa D Ventura-Marra, PhD, West Virginia University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2016
Primær fullføring (Faktiske)
1. mai 2016
Studiet fullført (Faktiske)
1. juni 2016
Datoer for studieregistrering
Først innsendt
25. september 2016
Først innsendt som oppfylte QC-kriteriene
17. oktober 2016
Først lagt ut (Anslag)
19. oktober 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
19. oktober 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. oktober 2016
Sist bekreftet
1. oktober 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1501549080
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Data will only be reported in aggregate.
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