NCT00941447

Development of Self-Regulation in Individuals With Type 2 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: The University of Tennessee, Knoxville · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	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).
BEHAVIORAL	Physical Activity	There is a physical Activity of 150 minutes/week of moderate-intense physical activity.
BEHAVIORAL	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.

Timeline

• Start date: 2009-04-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2009-07-17
• Last updated: 2018-04-05

Locations

1 site across 1 country: United States