Type 2 DiabetesNCT00941447
Development of Self-Regulation in Individuals With Type 2 Diabetes
A study testing Dietary, Physical Activity and Self-Regulatory Approaches in people with Type 2 Diabetes, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Dietary, Physical Activity and Self-Regulatory Approaches
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee, Healthy Eating and Activity Laboratory (HEAL)
Knoxville, Tennessee, 37996
About this study
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.
Read the 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
- Being tested
- Dietary, Physical Activity, Self-Regulatory Approaches
- Keywords
- Type 2 Diabetes, Obesity, Self-Regulation, Self-Efficacy
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietaryBehavioural
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).
Physical ActivityBehavioural
There is a physical Activity of 150 minutes/week of moderate-intense physical activity.
Self-Regulatory ApproachesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-Regulation | Experimental | Self Regulation Arm focuses on increasing participants self-monitoring blood glucose (SMBG) AND awareness of self-regulatory approaches to managing diabetes. Receives: Behavioral: Dietary; Behavioral: Physical Activity; Behavioral: Self-Regulatory Approaches |
| Self-Monitoring | Experimental | Self-Monitoring Arm focuses on increasing participants self-monitoring blood glucose (SMBG) and providing nutrition education ONLY. Receives: Behavioral: Dietary; Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose
Measured: 12 weeks
Secondary outcomes (5)
Caloric, fat and carbohydrate intake
Measured: 12 weeks
Self-efficacy
Measured: 12-weeks
Self-management activities
Measured: 12 weeks
Physical activities
Measured: 12 weeks
Quality of Life
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startApr 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Abbott Diabetes Care
- Responsible party
- Principal investigator, Hollie Raynor, The University of Tennessee, Knoxville
- Investigators
- Lusi M Martin, BA, Principal investigator, University of Tennessee, KnoxvilleHollie A Raynor, Ph.D, Study chair, University of Tennessee, Knoxville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941447
- Sponsor's protocol ID
- 3R01DK074721
- Status last verified
- Apr 2018
- First submitted
- 15 Jul 2009
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Self-Regulation in Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00941447
- Acronym / sponsor ID
- 3R01DK074721
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Obesity, Self-Regulation, Self-Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Abbott Diabetes Care
- Study start
- Apr 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 17 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Regulation | Experimental | Behavioral: Dietary, Behavioral: Physical Activity, Behavioral: Self-Regulatory ApproachesSelf Regulation Arm focuses on increasing participants self-monitoring blood glucose (SMBG) AND awareness of self-regulatory approaches to managing diabetes. |
| Self-Monitoring | Experimental | Behavioral: Dietary, Behavioral: Physical ActivitySelf-Monitoring Arm focuses on increasing participants self-monitoring blood glucose (SMBG) and providing nutrition education ONLY. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietaryAll 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). | Behavioural | Self-Monitoring, Self-Regulation |
| Physical ActivityThere is a physical Activity of 150 minutes/week of moderate-intense physical activity. | Behavioural | Self-Monitoring, Self-Regulation |
| Self-Regulatory ApproachesParticipants 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. | Behavioural | Self-Regulation |
Primary outcome
Blood Glucose
Time frame: 12 weeks
5 secondary outcomes
Caloric, fat and carbohydrate intake
Time frame: 12 weeks
Self-efficacy
Time frame: 12-weeks
Self-management activities
Time frame: 12 weeks
Physical activities
Time frame: 12 weeks
Quality of Life
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lusi M Martin, BA principal investigator
University of Tennessee, Knoxville
Hollie A Raynor, Ph.D study chair
University of Tennessee, Knoxville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary, Physical Activity and Self-Regulatory Approaches in people with Type 2 Diabetes, run by The University of Tennessee, Knoxville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Glucose (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.