Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Examining the Effects of Diet on Health With an Online Program

12. oktober 2015 opdateret af: University of California, San Francisco
The study is a pilot, designed to provide data regarding the feasibility and acceptability of conducting such a study on a larger scale. The present study is a randomized controlled clinical trial comparing two programs to help people manage diabetes and lose weight, one using a moderate-carbohydrate diet promoted by the American Diabetes Association (ADA) and the other using on a low-carbohydrate diet (LC) and mindfulness and positive affect lifestyle modifications. Intervention content will include information about nutrition (American Diabetes Association recommended diet or carbohydrate restriction) and, in the LC group, emotion regulation, positive affect, and mindful eating strategies.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Approximately individuals with type 2 diabetes will be randomized in a 1:1 ratio to treatment groups. Classes will occur online. Participants will be evaluated at 0, 16, and 32 weeks. Our main outcome of interest is HbA1c (glycated hemoglobin, a measure indicative of blood glucose levels and tied to diabetes severity).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

25

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94115
        • University of California, San Francisco

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

18 år til 100 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. HbA1c 6.5%-9% at screening.
  2. Aged 18 years old and older
  3. BMI 25 and above.
  4. Willing and able to participate in the interventions such as having sufficient control over their food intake. Must have the ability to make choices about the food they eat; cannot have a lifestyle in which they eat out most of their meals.)

Exclusion Criteria:

  1. Unable to provide informed consent.
  2. Non English speaker.
  3. No current use of insulin, no immediate plans to start or increase diabetic mediations, and no use of diabetes medications besides metformin.
  4. A substance abuse, mental health, or medical condition that, in the opinion of investigators, will make it difficult for the potential participant to participate in the intervention. Such conditions may include: cancer, liver failure, unstable coronary artery disease, severe emphysema, binge eating disorder or history of binge eating disorder, bulimia or strong history of bulimia.
  5. Previous use or recent changes in medications that can interfere with the measures used in the study: current use of insulin; use of systemic (oral or IV) corticosteroids in the 6 months prior to enrollment or severe autoimmune disorders or other conditions (e.g. rheumatoid arthritis, lupus), that are likely to require these medications; and initiation of new class of psychiatric medications in past 2 months.
  6. Pregnant or planning to get pregnant in the next 12 months, breastfeeding or less than 6 months post-partum.
  7. Current use of weight loss medications or supplements such as Alli or amphetamine-based drugs that are believed to have some effect on weight.
  8. History of or planned weight loss surgery.
  9. Vegan or vegetarian. The intervention diets are more challenging for vegan and vegetarian participants.
  10. No or very limited internet access at a computer. Must be able to complete the online assessments and access the online class materials.

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
Aktiv komparator: American Diabetes Association recommended diet
Participants in the American Diabetes Association (ADA) diet group will receive standard ADA advice. The diet includes high-fiber foods (such as vegetables, fruits, whole grains, and legumes), low-fat dairy products, fresh fish, and foods low in saturated fat. They will be asked to use the "plate method" to guide their nutritional choices.
Adfærdsmæssigt: American Diabetes Association diæt
Eksperimentel: Low Carbohydrate Diet

Participants will be instructed to follow a low carbohydrate, ketogenic diet: carbohydrate intake 20-35 grams a day not including fiber. Foods permitted include: meats, poultry, fish, eggs, cheese, cream, some nuts and seeds, green leafy vegetables, and most other non-starchy vegetables. Because most individuals self-limit caloric intake, no calorie restriction will be recommended.

Participants will also be taught information about mindfulness and positive affect practices. The mindfulness-based curriculum will focus on the following elements: training on topics such as mindful meditation, mindful eating, awareness of fullness and hunger signals, and taste satiety. The positive emotion curriculum will include: training on topics such as noticing and savoring positive events, gratitude, positive reappraisal, personal strengths, attainable goals, and acts of kindness.
Adfærdsmæssigt: Behavioral: Low Carbohydrate, Ketogenic Diet
Adfærdsmæssigt: Mindfulness og positive affektevner

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hemoglobin A1c
Tidsramme: baseline to 16 weeks
We will test whether Hemoglobin A1c changes from pre-intervention to 16 weeks. The key outcome measure will compare the two groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 16 weeks.
baseline to 16 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hemoglobin A1c
Tidsramme: baseline to 32 weeks
We will test whether Hemoglobin A1c changes from pre-intervention to 32 weeks. The key outcome measure will compare the two groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 32 weeks.
baseline to 32 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body weight
Tidsramme: baseline to 16 weeks
We will test whether body weight changes from pre-intervention to 16 weeks. The key outcome measure will compare the two groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 16 weeks.
baseline to 16 weeks
Body weight
Tidsramme: baseline to 32 weeks
We will test whether body weight changes from pre-intervention to 32 weeks. The key outcome measure will compare the two groups, but we will also assess whether statistically significant changes occur within groups from pre-intervention to 32 weeks.
baseline to 32 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, San Francisco

Efterforskere

  • Ledende efterforsker: Rick Hecht, MD, University of California, San Francisco
  • Ledende efterforsker: Laura R Saslow, PhD, University of Michigan

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

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. oktober 2013

Primær færdiggørelse (Faktiske)

1. juni 2015

Studieafslutning (Faktiske)

1. juni 2015

Datoer for studieregistrering

Først indsendt

18. oktober 2013

Først indsendt, der opfyldte QC-kriterier

18. oktober 2013

Først opslået (Skøn)

23. oktober 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. oktober 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. oktober 2015

Sidst verificeret

1. oktober 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 13-11813

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 .

Kliniske forsøg med Type 2 diabetes

Kliniske forsøg med American Diabetes Association diæt

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Nigeria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner