Development of Self-Regulation in Individuals With Type 2 Diabetes
1 other identifier
interventional
15
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes
Started Apr 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 15, 2009
CompletedFirst Posted
Study publicly available on registry
July 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedApril 5, 2018
April 1, 2018
1.8 years
July 15, 2009
April 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood Glucose
12 weeks
Secondary Outcomes (5)
Caloric, fat and carbohydrate intake
12 weeks
Self-efficacy
12-weeks
Self-management activities
12 weeks
Physical activities
12 weeks
Quality of Life
12 weeks
Study Arms (2)
Self-Regulation
EXPERIMENTALSelf Regulation Arm focuses on increasing participants self-monitoring blood glucose (SMBG) AND awareness of self-regulatory approaches to managing diabetes.
Self-Monitoring
EXPERIMENTALSelf-Monitoring Arm focuses on increasing participants self-monitoring blood glucose (SMBG) and providing nutrition education ONLY.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Tennessee, Healthy Eating and Activity Laboratory (HEAL)
Knoxville, Tennessee, 37996, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lusi M Martin, BA
University of Tennessee, Knoxville
- STUDY CHAIR
Hollie A Raynor, Ph.D
University of Tennessee, Knoxville
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 15, 2009
First Posted
July 17, 2009
Study Start
April 1, 2009
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
April 5, 2018
Record last verified: 2018-04