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Development of Self-Regulation in Individuals With Type 2 Diabetes

3. april 2018 opdateret af: Hollie Raynor, The University of Tennessee, Knoxville
The purpose of this investigation is to conduct a 12-week study to compare the effects of a self-regulation intervention (SR), in which participants will self-monitor their blood glucose (BG) and adjust dietary intake and physical activity through the use of current dietary and physical activity guidelines to help regulate their BG, to an education and self-monitoring only intervention (SM), on blood glucose, self-efficacy, and diabetes self-management activities.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

As our nation continues to battle overweight and obesity, the prevalence of diabetes will precipitously increase, placing additional financial burden on our country. Therefore, finding ways to manage this chronic disease is essential. While self-monitoring of blood glucose (SMBG) has been shown to be effective in improving glycemic control in individuals with type 1 diabetes, the importance of encouraging individuals with type 2 diabetes to engage in SMBG for better blood glucose (BG) is still unclear. SMBG is believed to be key in the self-management of diabetes, as it can provide feedback on dietary and activity behaviors that are believed to impact on BG. The use of SMBG to adjust other behaviors that impact on BG is a self-regulatory approach to diabetes management. Self-regulation of BG is theorized to impact on self-efficacy in the management of diabetes. Through greater self-efficacy, greater compliance to diabetes self-management behaviors is achieved. Currently, no trial has examined the use of a self-regulation approach using current dietary and physical activity recommendations for individuals with type 2 diabetes who are not on insulin.

Thus, this investigation will involve a 12-week study to examine the effect of an SR intervention to SM intervention. All participants in the investigation will receive a standard 12-week behavioral intervention. The intervention will include a reduced caloric prescription (1200-1500 kcal/day), fat gram prescription (30% or less kcals from fat), carbohydrate gram prescription (150-190 grams/day) and a physical activity goal (slowly building up to 150minutes/week of moderate-intense physical activity at the end of study).

Participants will be assessed at 0 and 13 weeks (pre- and post-intervention) on measures of fasting blood glucose, self-efficacy, and diabetes self-management activities. Additionally, dietary intake, physical activity, quality of life and body weight measurements will be taken at 0 and 13 weeks for comparisons between the two treatment groups.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

15

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37996
        • University of Tennessee, Healthy Eating and Activity Laboratory (HEAL)

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

21 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Recruitment from Cherokee Health Systems, Healthy Eating and Activity Laboratory Ineligible Database, UTK faculty and staff, and local endocrinologists' offices.
  • Have been diagnosed with Type 2 diabetes for a minimum of 1 year.
  • Fasting BG of ≥ 126mg/dl6.
  • Between the age of 21 and 65 years. Older adults may have more medical co-morbidities and may require greater medical supervision29.
  • Considered overweight or obese by the body mass index (BMI). BMI between 27 and 45 kg/m2 29. The American Diabetes Association 2008 position statement for current nutrition recommendations and interventions for diabetes encourages those individuals within this BMI range to follow the low-calorie, low-fat diet that is prescribed in both conditions in this investigation6.
  • Not treated with insulin.
  • Are taking medicine that do not typically cause hypoglycemia: Refer to diabetes medication list in Appendices Ai-Aii.
  • Willing to increase physical activity to 150mins/week in 3 months.
  • Willing to be randomized to either condition.
  • Able to report that they can read and understand English.
  • Able to report that they can keep a food diary and perform basic mathematics.

Exclusion Criteria:

  • Report a heart condition, chest pain during periods of activity or rest or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Individuals self-reporting joint problems, prescription medication usage related to heart conditions, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
  • Report being unable to walk for 2 blocks (1/4 mile) without stopping.
  • Report major psychiatric diseases.
  • Are compliant with dietary and physical activity recommendations to achieve ideal body weight.
  • Taking any weight loss medication.
  • Pregnant, expecting to be pregnant and/or lactating.
  • Have no working phone.
  • Are unwilling to participate in phone calls that are a part of the condition that in which they have been randomized.

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: Self-Regulation
Self Regulation Arm focuses on increasing participants self-monitoring blood glucose (SMBG) AND awareness of self-regulatory approaches to managing diabetes.
Adfærdsmæssigt: Dietary
All participants in the investigation will receive a standard 12-week behavioral intervention with seven 30-45 minute phone interventions and education sessions. The intervention includes a reduced caloric prescription (1200-1500 kcal/day),fat gram prescription (30% or less kcals from fat) and carbohydrate gram prescription (150-190 grams).
Adfærdsmæssigt: Physical Activity
There is a physical Activity of 150 minutes/week of moderate-intense physical activity.
Adfærdsmæssigt: Self-Regulatory Approaches
Participants in this arm will receive extensive feedback based on their self-monitoring diary in which the researcher will be reinforced in areas that they are doing well in regarding their blood glucose and also assist in problem solving in areas that need improvement.
Eksperimentel: Self-Monitoring
Self-Monitoring Arm focuses on increasing participants self-monitoring blood glucose (SMBG) and providing nutrition education ONLY.
Adfærdsmæssigt: Dietary
All participants in the investigation will receive a standard 12-week behavioral intervention with seven 30-45 minute phone interventions and education sessions. The intervention includes a reduced caloric prescription (1200-1500 kcal/day),fat gram prescription (30% or less kcals from fat) and carbohydrate gram prescription (150-190 grams).
Adfærdsmæssigt: Physical Activity
There is a physical Activity of 150 minutes/week of moderate-intense physical activity.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Blood Glucose
Tidsramme: 12 weeks
12 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Livskvalitet
Tidsramme: 12 uger
12 uger
Caloric, fat and carbohydrate intake
Tidsramme: 12 weeks
12 weeks
Self-efficacy
Tidsramme: 12-weeks
12-weeks
Self-management activities
Tidsramme: 12 weeks
12 weeks
Physical activities
Tidsramme: 12 weeks
12 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

The University of Tennessee, Knoxville

Samarbejdspartnere

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Abbott Diabetes Care

Efterforskere

  • Ledende efterforsker: Lusi M Martin, BA, University of Tennessee, Knoxville
  • Studiestol: Hollie A Raynor, Ph.D, University of Tennessee, Knoxville

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. april 2009

Primær færdiggørelse (Faktiske)

1. februar 2011

Studieafslutning (Faktiske)

1. februar 2011

Datoer for studieregistrering

Først indsendt

15. juli 2009

Først indsendt, der opfyldte QC-kriterier

16. juli 2009

Først opslået (Skøn)

17. juli 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. april 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. april 2018

Sidst verificeret

1. april 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 3R01DK074721 (U.S. NIH-bevilling/kontrakt)

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 .

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