Development of Self-Regulation in Individuals With Type 2 Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 4/17/2018 |
| Start Date: | April 2009 |
| End Date: | February 2011 |
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.
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.
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.
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.
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.
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