Tidsbegrænset spisning (TRE) blandt indfødte Hawaiian/Pacific Islander kvinder i risiko for endometriecancer (TIMESPAN)
Gennemførlighed og accept af tidsbegrænset spisning (TRE) blandt indfødte Hawaiian/Pacific Islander kvinder i risiko for endometriecancer
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Tilmelding: Studiet omfatter to faser. Fase 1 omfatter fokusgrupper blandt 30 indfødte Hawaiian/Pacific Islander kvinder med risiko for endometriecancer. Fokusgrupper vil bestemme sociokulturelle påvirkninger på (i) diætadfærd, herunder måltidstiming; (ii) diætpræferencer; (iii) foreslåede madplaner og interventionsdesign; (iv) opfattelser af vægttab og kropsopfattelse. I den anden undersøgelsesfase vil undersøgelsesholdet rekruttere 10 Pacific Islander-kvinder til at deltage i et 14-ugers randomiseret kost-crossover-studie. Hver kvinde vil deltage i begge interventionsarme og fungere som sin egen kontrol.
Fokusgruppe: For at nå alle aspekter af mål 1 af denne undersøgelse, vil undersøgelsesholdet rekruttere 30 Pacific Islander-kvinder med risiko for endometriecancer til at gennemføre virtuelle fokusgrupper. Disse fokusgrupper vil finde sted via privat videokonference, som Zoom, og en sprogoversætter vil blive stillet til rådighed efter behov. Fokusgrupperne vil blive overværet af en indfødt Hawaiian/Pacific Islander Community Expert. Spørgsmål vil blive designet til at forstå sociokulturelle påvirkninger på diætadfærd (spørgsmål om social spisning, timing af måltider og diætpræferencer, indhentning af feedback på design af undersøgelsesinterventionslevering og opfattelser af vægttab og kropsopfattelse). En isbryder vil blive gennemført inden den formelle afhøring. Sessioner vil blive lydoptaget på videokonferencen og en ekstra enhed, transskriberet ordret og kontrolleret for nøjagtighed. Yderligere to teammedlemmer vil være til stede som notattagere. Vores samfundsekspert vil være til stede for at hjælpe med at facilitere sessionen. Spørgsmål vil blive stillet i begyndelsen af sessionen for at sikre kulturel følsomhed.
Diætintervention: Diætinterventionen inkluderer 5 undersøgelsesbesøg og omfatter et baselinebesøg, 2-ugers indkøringsperiode, 4-ugers kontroldiætplan, 4-ugers udvaskningsperiode og en 4-ugers, 8 til 10-timers tid Restricted Eating (TRE) protokol (8 til 10 timers fodring og 14 til 16 timers fasteperioder). Et opfølgende spørgeskema vil blive sendt 6 måneder efter interventionen. Til kontrolskemaet vil kvinder modtage frosne frokost- og middagsmåltider og en standardiseret morgenmads- og snackmenu. Alle måltider og morgenmads-/snackmenuen vil blive designet til at være kulturelt kompetente med feedback fra fokusgrupperne, og madplanerne vil blive individualiseret for at imødekomme energikravene til vægtvedligeholdelse. For TRE-skemaet vil kvinder modtage tilberedte frosne frokost- og middagsmåltider i henhold til kontrolskemaet, men vil blive bedt om at indtage daglige måltider, snacks og kalorieholdige drikkevarer inden for en 8 til 10-timers periode, der passer til deres tidsplan. De vil blive bedt om at opretholde deres normale søvn- og fysiske aktivitetsplan. Fasteperioden vil stige i løbet af den første uge (dage 1-3, 12-14 timer pr. dag, dag 4-6, 14-16 timer pr. dag, dag 7+, 16 timer pr. dag). Kvinder vil blive bedt om at planlægge spiseperioden på samme tidspunkt hver dag. Alle måltider (kontrol og TRE) vil blive leveret af Metabolic Kitchen på University of Utah.
Besøg 1: Under baseline-besøget vil en koordinator indhente samtykke fra deltageren, og de vil blive bedt om at konkurrere på spørgeskemaer, der spørger om kliniske og demografiske faktorer, kronotype og fysisk aktivitet, og forskellige antropometriske målinger vil blive taget. Efter baseline-besøget vil deltagerne gennemgå en 2-ugers indkøringsperiode. I løbet af denne tid er målet at registrere kvinders sædvanlige tidspunkter for spiseepisoder og appetit, mens de følger deres sædvanlige diæt.
Besøg 2: Kvinder vil give fastende blod- og afføringsprøver, og der vil blive taget antropometriske målinger. Efter besøg 2 vil deltagerne gennemgå kontrol- eller TRE-skemaet i 4 uger.
Besøg 3: Efter 4 uger vil deltagerne gennemgå besøg 3 og vil blive bedt om at give fastende blod- og afføringsprøver, og der vil blive taget antropometriske foranstaltninger. Efter besøg 3 vil deltagerne gennemgå en 4-ugers udvaskningsperiode, hvor kvinder kan vende tilbage til deres sædvanlige livsstil.
Besøg 4: Besøg 4 vil finde sted efter den 4-ugers udvaskningsperiode og vil omfatte en telefonkonsultation for at diskutere den næste studiefase og planlægge måltider. I de følgende 4 uger vil deltagerne derefter gennemgå den modsatte fodringsplan (enten kontrol eller TRE).
Besøg 5: Under det sidste besøg vil kvinder give fastende blod- og afføringsprøver, og der vil blive taget antropometriske foranstaltninger.
I løbet af indkøringsperioden, TRE-fasen og kontrolfasen vil deltagerne registrere timingen af spiseepisoder ved hjælp af MyCircadian Clock-telefonappen, fuldføre 3 x 24-timers kosttilbagekaldelser, en enkelt tilbagekaldelse af fysisk aktivitet og 7-dages søvn og fysisk aktivitet vil blive målt objektivt ved hjælp af en Actiwatch-enhed. Sult og mæthed vil blive evalueret tilfældigt gennem MyCircadian Clock-telefonappen.
Et studieudgangsinterview vil blive gennemført via Zoom-konferenceopkald for at debriefe om interventionen og indhente detaljerede oplysninger om accept af protokollen. Cirka 6 måneder efter afslutningen af interventionsperioden vil kvinder udfylde et opfølgende spørgeskema med posten.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84112
- Huntsman Cancer Institute
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
Alle mål:
- Indfødte Hawaiian/Pacific Islander hunner i alderen 18 år eller ældre
- Overvægtig eller fede (BMI>25 kg/m2) ELLER har en historie med ikke-insulinafhængig diabetes ELLER har en historie med kompleks atypisk endometriehyperplasi
- Har en fungerende mobiltelefon, der kan downloade en app
- Kan bruge mobiltelefon om dagen (fx på arbejde)
- Ikke en natholdsarbejder
Gælder kun for mål 2 og 3:
- Kunne deltage i studiebesøg på Huntsman Cancer Institute Center for HOPE
Ekskluderingskriterier:
Alle mål:
- Kan ikke give informeret samtykke
Gælder kun for mål 2 og 3:
- Nødvendigheden af en særlig diæt, der udelukker justering af måltidets timing og/eller indhold af makronæringsstoffer
- Har en historie med insulinafhængig diabetes
- Har en historie med hysterektomi
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Time Restricted Eating (TRE) Schedule, Then Control
In this arm of the 14-week randomized dietary crossover study, participants will undergo a 2-week run-in period, followed by an 8-hour TRE protocol (comprising 8 hours of feeding and 16 hours of fasting periods), a 4-week washout period, and a 4-week control diet schedule.
|
Women will receive prepared frozen lunch and dinner meals as per the control schedule, but will be asked to consume daily meals, snacks, and calorie-containing beverages within an 8 to 10-hour period that fits their schedule.
They will be asked to maintain their regular sleep and physical activity schedule.
Fasting period will ramp up during the first week (e.g., Days 1-3, 12-14 h per day, Days 4-6, 14-16 h per day, Days 7+, 16 h per day).
Women will be asked to schedule the feeding period at the same time each day.
They will be allowed to consume water and 1-2 servings of very low-calorie drinks and foods (e.g., herbal tea, diet drinks, mints, gum containing < 4 kcal/serving) to increase compliance.
All meals (control and TRE) will be provided by the Metabolic Kitchen developed in collaboration with the department of Nutrition and Integrative Physiology.
Women will receive frozen lunch/dinner meals and a standardized breakfast and snacks menu.
All meals and the breakfast/snack menu will be designed to be culturally competent.
The meal plans will be individualized to meet weight maintenance energy requirements.
|
|
Eksperimentel: Control Schedule, Then TRE
In this arm of the 14-week randomized dietary crossover study, participants will undergo a 2-week run-in period, followed by 4-week control diet schedule, a 4-week washout period, and an 8-hour TRE protocol (comprising 8 hours of feeding and 16 hours of fasting periods)
|
Women will receive prepared frozen lunch and dinner meals as per the control schedule, but will be asked to consume daily meals, snacks, and calorie-containing beverages within an 8 to 10-hour period that fits their schedule.
They will be asked to maintain their regular sleep and physical activity schedule.
Fasting period will ramp up during the first week (e.g., Days 1-3, 12-14 h per day, Days 4-6, 14-16 h per day, Days 7+, 16 h per day).
Women will be asked to schedule the feeding period at the same time each day.
They will be allowed to consume water and 1-2 servings of very low-calorie drinks and foods (e.g., herbal tea, diet drinks, mints, gum containing < 4 kcal/serving) to increase compliance.
All meals (control and TRE) will be provided by the Metabolic Kitchen developed in collaboration with the department of Nutrition and Integrative Physiology.
Women will receive frozen lunch/dinner meals and a standardized breakfast and snacks menu.
All meals and the breakfast/snack menu will be designed to be culturally competent.
The meal plans will be individualized to meet weight maintenance energy requirements.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of Participants Referred That Were Consented and Enrolled
Tidsramme: up to 1 day after screening
|
The feasibility of the Time-Restricted Eating (TRE) intervention will be measured by calculating the proportion (%) of women who were consented and enrolled in the study out of all the participants who screened for the trial.
|
up to 1 day after screening
|
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Attrition
Tidsramme: From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks
|
To assess the feasibility of the TRE intervention.
This outcome measure will report the number of participants who withdrew throughout the course of the interventional component of the study.
|
From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks
|
|
Protocol Items Completed
Tidsramme: From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks
|
This outcome measure will report the count of participants who completed each study assessment per protocol. Participants who were randomized and withdrew from the study are included as missed assessments. After the TRE Schedule (Visit 3 or 5), waist circumference, weight, blood pressure, blood, and stool were collected. After the Control Schedule (Visit 3 or 5), waist circumference, weight, blood pressure, blood, and stool were collected. This outcome measure will report the count of participants who completed each assessment |
From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks
|
|
Percentage of TRE-Adherent Days
Tidsramme: From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
This outcome measure will report the mean percentage of TRE-adherent days.
TRE adherence is achieved when participants fast for 14-18 hours per day during the TRE phase, as measured by a mealtime log using the MyCircadianClock phone app.
|
From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
|
Meals Delivered On Schedule
Tidsramme: From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks
|
Count of participants whose pre-made control diet meals were delivered on schedule.
Participants were provided with pre-made, frozen lunch and dinner meals 7 days a week during both 4-week diet phases.
|
From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks
|
|
Study Visit Completion
Tidsramme: From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks
|
To assess feasibility of the study, the percentage of in-person study visits completed out of 5 study visits for each participant was calculated. This outcome measure will report the mean percentage of completed study visits. This outcome measure was assessed throughout the course of the study during both the TRE and Control Schedules; it is not possible to regroup participants to report Arms/Groups "per intervention". |
From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood Pressure Measured With Electronic Blood Pressure Monitor
Tidsramme: From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
Blood pressure was measured using an electronic blood pressure monitor after the TRE phase and after the control diet phase.
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From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
|
Waist Circumference
Tidsramme: From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
Waist circumference was measured by trained study staff using a tape measure and standardized protocols.
Waist circumference was measured after the TRE Schedule and after the Control Schedule.
|
From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
|
Body Mass Index (BMI) Assessed Via Stadiometer and Calibrated Scales
Tidsramme: From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
Participants' height and weight was measured by trained study staff using a stadiometer and calibrated weighing scales.
Measures were done in triplicate (duplicate if measures did not agree).
Height and weight were used to calculate body mass index in kilograms divided by height in meters-squared.
BMI was measured after the TRE Schedule and after the Control Schedule.
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From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
|
Fasting Blood Glucose Level
Tidsramme: From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
Fasting glucose was measured at Associated Regional and University Pathologists (ARUP) Laboratories.
Fasting blood samples were taken from participants by a trained phlebotomist using standard protocols after the TRE Schedule and after the Control Schedule.
|
From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
|
Fasting Blood C-peptide Level
Tidsramme: From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
C-peptide was measured at ARUP Laboratories.
Fasting blood samples were taken by a trained phlebotomist using standardized protocols after the TRE Schedule and after the Control Schedule.
|
From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
|
Fasting Blood Triglyceride Level
Tidsramme: From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
Blood triglyceride level was measured at ARUP Laboratories.
Fasting blood samples were taken by a trained phlebotomist using standardized protocols after the TRE Schedule and after the Control Schedule.
|
From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
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Fasting Blood High-density Lipoprotein(HDL)-Cholesterol Level
Tidsramme: From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
Blood HDL-cholesterol level was measured at ARUP Laboratories.
Fasting blood samples were taken by a trained phlebotomist using standardized protocols after the TRE Schedule and after the Control Schedule.
|
From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
|
Fasting Blood High Sensitivity C-reactive Protein
Tidsramme: From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
Blood C-peptide level was measured at ARUP Laboratories.
Fasting blood samples were taken by a trained phlebotomist using standardized protocols after the TRE Schedule and after the Control Schedule.
|
From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Mary Playdon, PhD, MPH, University of Utah
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Livmodersygdomme
- Kønssygdomme, kvindelige
- Genitale neoplasmer, kvindelige
- Uterine neoplasmer
- Opførsel
- Fodringsadfærd
- Faste
- Endometriale neoplasmer
- Intermitterende faste
- Organisation og administration
- Sundhedstjenester Administration
- Glykosidhydrolaser
- Hydrolaser
- Enzymer
- Enzymer og coenzymer
- Disaccharidaser
- Aftaler og tidsplaner
- Trehalase
Andre undersøgelses-id-numre
- 127142
- UL1TR002538 (U.S. NIH-bevilling/kontrakt)
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