- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01967992
Examining the Effects of Diet on Health With an Online Program
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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-
California
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San Francisco, California, Forente stater, 94115
- University of California, San Francisco
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- HbA1c 6.5%-9% at screening.
- Aged 18 years old and older
- BMI 25 and above.
- 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:
- Unable to provide informed consent.
- Non English speaker.
- No current use of insulin, no immediate plans to start or increase diabetic mediations, and no use of diabetes medications besides metformin.
- 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.
- 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.
- Pregnant or planning to get pregnant in the next 12 months, breastfeeding or less than 6 months post-partum.
- Current use of weight loss medications or supplements such as Alli or amphetamine-based drugs that are believed to have some effect on weight.
- History of or planned weight loss surgery.
- Vegan or vegetarian. The intervention diets are more challenging for vegan and vegetarian participants.
- No or very limited internet access at a computer. Must be able to complete the online assessments and access the online class materials.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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.
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|
|
Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Rick Hecht, MD, University of California, San Francisco
- Hovedetterforsker: Laura R Saslow, PhD, University of Michigan
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 13-11813
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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