Development of Self-Regulation in Individuals With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

Intervention name(s): Dietary; Physical Activity; Self-Regulatory Approaches
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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).; There is a physical Activity of 150 minutes/week of moderate-intense physical activity.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; Obesity; Self-Regulation; Self-Efficacy