ID

42763

Description

Development of Self-Regulation in Individuals With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00941447

Link

https://clinicaltrials.gov/show/NCT00941447

Keywords

Versions (2)
  1. 11/28/18 11/28/18 -
  2. 9/17/21 9/17/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00941447

English

Eligibility Type 2 Diabetes NCT00941447

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
recruitment from cherokee health systems, healthy eating and activity laboratory ineligible database, utk faculty and staff, and local endocrinologists' offices.
Description

Patient Recruitment

Data type

boolean

Alias
UMLS CUI [1]
C0242800
have been diagnosed with type 2 diabetes for a minimum of 1 year.
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
fasting bg of ≥ 126mg/dl6.
Description

Fasting blood glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428568
between the age of 21 and 65 years. older adults may have more medical co-morbidities and may require greater medical supervision29.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
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.
Description

Overweight | Obesity | Body mass index | Encouragement Low-Calorie Diet | Encouragement Fat-Restricted Diet

Data type

boolean

Alias
UMLS CUI [1]
C0497406
UMLS CUI [2]
C0028754
UMLS CUI [3]
C1305855
UMLS CUI [4,1]
C0870494
UMLS CUI [4,2]
C2930544
UMLS CUI [5,1]
C0870494
UMLS CUI [5,2]
C0242970
not treated with insulin.
Description

Insulin Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0332197
are taking medicine that do not typically cause hypoglycemia: refer to diabetes medication list in appendices ai-aii.
Description

Absence Pharmaceutical Preparations Causing Hypoglycemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0678227
UMLS CUI [1,4]
C0020615
willing to increase physical activity to 150mins/week in 3 months.
Description

Increase in physical activity minutes per week Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C3694428
UMLS CUI [1,2]
C0556975
UMLS CUI [1,3]
C0600109
willing to be randomized to either condition.
Description

Randomization Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0600109
able to report that they can read and understand english.
Description

Able to read English Language | Comprehension English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C0376245
able to report that they can keep a food diary and perform basic mathematics.
Description

Food diary Completion | Ability Perform Mathematics

Data type

boolean

Alias
UMLS CUI [1,1]
C0012157
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C0884358
UMLS CUI [2,3]
C0024934
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
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.
Description

Heart condition | Chest Pain During Activity | Chest Pain At rest | Unconscious State

Data type

boolean

Alias
UMLS CUI [1]
C3842523
UMLS CUI [2,1]
C0008031
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C0026606
UMLS CUI [3,1]
C0008031
UMLS CUI [3,2]
C0443144
UMLS CUI [4]
C0041657
report being unable to walk for 2 blocks (1/4 mile) without stopping.
Description

Lacking Able to walk Block Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712089
UMLS CUI [1,3]
C1706084
UMLS CUI [1,4]
C1265611
report major psychiatric diseases.
Description

Major psychiatric illness

Data type

boolean

Alias
UMLS CUI [1]
C4534351
are compliant with dietary and physical activity recommendations to achieve ideal body weight.
Description

Compliance behavior Recommendations Dietary | Compliance behavior Recommendations Physical activity | Ideal Body Weight intended

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0034866
UMLS CUI [1,3]
C0012155
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0034866
UMLS CUI [2,3]
C0026606
UMLS CUI [3,1]
C0421272
UMLS CUI [3,2]
C1283828
taking any weight loss medication.
Description

Weight-Loss Agents

Data type

boolean

Alias
UMLS CUI [1]
C0376606
pregnant, expecting to be pregnant and/or lactating.
Description

Pregnancy | Pregnancy, Planned | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
have no working phone.
Description

Working Phone Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0043227
UMLS CUI [1,2]
C0039457
UMLS CUI [1,3]
C0332197
are unwilling to participate in phone calls that are a part of the condition that in which they have been randomized.
Description

Participation Telephone call Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0302186
UMLS CUI [1,3]
C0558080
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Similar models

Eligibility Type 2 Diabetes NCT00941447

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patient Recruitment
Item
recruitment from cherokee health systems, healthy eating and activity laboratory ineligible database, utk faculty and staff, and local endocrinologists' offices.
boolean
C0242800 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
have been diagnosed with type 2 diabetes for a minimum of 1 year.
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Fasting blood glucose measurement
Item
fasting bg of ≥ 126mg/dl6.
boolean
C0428568 (UMLS CUI [1])
Age
Item
between the age of 21 and 65 years. older adults may have more medical co-morbidities and may require greater medical supervision29.
boolean
C0001779 (UMLS CUI [1])
Overweight | Obesity | Body mass index | Encouragement Low-Calorie Diet | Encouragement Fat-Restricted Diet
Item
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.
boolean
C0497406 (UMLS CUI [1])
C0028754 (UMLS CUI [2])
C1305855 (UMLS CUI [3])
C0870494 (UMLS CUI [4,1])
C2930544 (UMLS CUI [4,2])
C0870494 (UMLS CUI [5,1])
C0242970 (UMLS CUI [5,2])
Insulin Absent
Item
not treated with insulin.
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Absence Pharmaceutical Preparations Causing Hypoglycemia
Item
are taking medicine that do not typically cause hypoglycemia: refer to diabetes medication list in appendices ai-aii.
boolean
C0332197 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0678227 (UMLS CUI [1,3])
C0020615 (UMLS CUI [1,4])
Increase in physical activity minutes per week Willing
Item
willing to increase physical activity to 150mins/week in 3 months.
boolean
C3694428 (UMLS CUI [1,1])
C0556975 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Randomization Willing
Item
willing to be randomized to either condition.
boolean
C0034656 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Able to read English Language | Comprehension English Language
Item
able to report that they can read and understand english.
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0233733 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Food diary Completion | Ability Perform Mathematics
Item
able to report that they can keep a food diary and perform basic mathematics.
boolean
C0012157 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0085732 (UMLS CUI [2,1])
C0884358 (UMLS CUI [2,2])
C0024934 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Heart condition | Chest Pain During Activity | Chest Pain At rest | Unconscious State
Item
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.
boolean
C3842523 (UMLS CUI [1])
C0008031 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0026606 (UMLS CUI [2,3])
C0008031 (UMLS CUI [3,1])
C0443144 (UMLS CUI [3,2])
C0041657 (UMLS CUI [4])
Lacking Able to walk Block Quantity
Item
report being unable to walk for 2 blocks (1/4 mile) without stopping.
boolean
C0332268 (UMLS CUI [1,1])
C2712089 (UMLS CUI [1,2])
C1706084 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Major psychiatric illness
Item
report major psychiatric diseases.
boolean
C4534351 (UMLS CUI [1])
Compliance behavior Recommendations Dietary | Compliance behavior Recommendations Physical activity | Ideal Body Weight intended
Item
are compliant with dietary and physical activity recommendations to achieve ideal body weight.
boolean
C1321605 (UMLS CUI [1,1])
C0034866 (UMLS CUI [1,2])
C0012155 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C0034866 (UMLS CUI [2,2])
C0026606 (UMLS CUI [2,3])
C0421272 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
Weight-Loss Agents
Item
taking any weight loss medication.
boolean
C0376606 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
pregnant, expecting to be pregnant and/or lactating.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Working Phone Absent
Item
have no working phone.
boolean
C0043227 (UMLS CUI [1,1])
C0039457 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Participation Telephone call Unwilling
Item
are unwilling to participate in phone calls that are a part of the condition that in which they have been randomized.
boolean
C0679823 (UMLS CUI [1,1])
C0302186 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
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