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Development of Self-Regulation in Individuals With Type 2 Diabetes

3 avril 2018 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

15

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Tennessee
      • Knoxville, Tennessee, États-Unis, 37996
        • University of Tennessee, Healthy Eating and Activity Laboratory (HEAL)

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

21 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Self-Regulation
Self Regulation Arm focuses on increasing participants self-monitoring blood glucose (SMBG) AND awareness of self-regulatory approaches to managing diabetes.
Comportemental: 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).
Comportemental: Physical Activity
There is a physical Activity of 150 minutes/week of moderate-intense physical activity.
Comportemental: 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.
Expérimental: Self-Monitoring
Self-Monitoring Arm focuses on increasing participants self-monitoring blood glucose (SMBG) and providing nutrition education ONLY.
Comportemental: 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).
Comportemental: Physical Activity
There is a physical Activity of 150 minutes/week of moderate-intense physical activity.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Blood Glucose
Délai: 12 weeks
12 weeks

Mesures de résultats secondaires

Mesure des résultats
Délai
Qualité de vie
Délai: 12 semaines
12 semaines
Caloric, fat and carbohydrate intake
Délai: 12 weeks
12 weeks
Self-efficacy
Délai: 12-weeks
12-weeks
Self-management activities
Délai: 12 weeks
12 weeks
Physical activities
Délai: 12 weeks
12 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

The University of Tennessee, Knoxville

Collaborateurs

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

Les enquêteurs

  • Chercheur principal: Lusi M Martin, BA, University of Tennessee, Knoxville
  • Chaise d'étude: Hollie A Raynor, Ph.D, University of Tennessee, Knoxville

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2009

Achèvement primaire (Réel)

1 février 2011

Achèvement de l'étude (Réel)

1 février 2011

Dates d'inscription aux études

Première soumission

15 juillet 2009

Première soumission répondant aux critères de contrôle qualité

16 juillet 2009

Première publication (Estimation)

17 juillet 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 avril 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 avril 2018

Dernière vérification

1 avril 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 3R01DK074721 (Subvention/contrat des NIH des États-Unis)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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