Behavioral Change Communication (BCC) to Promote Physical Activity Among Females With Type 2 Diabetes Mellitus Attending Diabetic Clinic
| Tracking Information | |||||
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| First Received Date ICMJE | June 2, 2008 | ||||
| Last Updated Date | June 3, 2008 | ||||
| Start Date ICMJE | May 2006 | ||||
| Primary Completion Date | July 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
incremental physical activity [ Time Frame: at the end of 4 months-October ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00690326 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
glycosylated hemoglobin [ Time Frame: At the end of 4 months -October ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Behavioral Change Communication (BCC) to Promote Physical Activity Among Females With Type 2 Diabetes Mellitus Attending Diabetic Clinic | ||||
| Official Title ICMJE | Behavioral Change Communication to Promote Physical Activity Among Females With Type 2 Diabetes Mellitus Attending Diabetic Clinic. | ||||
| Brief Summary | Type 2DM is present in the populations of almost all the countries in the world and is a significant disease burden in most countries .Evidences suggest that population in India develop Type 2 DM at an increasing rate as they reject their traditional life styles. Awareness and knowledge regarding Diabetes and role of physical inactivity in producing complications is still grossly inadequate( Mohan. D, Raj.D Awareness and knowledge of Diabetes in Chennai.The Chennai urban Rural Epidemiology study(CURES-9)J Assoc. Physicians India 2005 April;53:283-7).Exercise is a low cost , non pharmacological intervention that has been shown to be effective in metabolic control. Exercise is still vastly under-utilized in the management of Type 2 DM. Most proximal behavioral cause of insulin resistance is physical inactivity.(Michael J. LaMonte, Steven N. Blair et al.( Physical activity and Diabetes prevention J Appl Physiol. 99: 1205-1213,2005) This study was designed to promote physical activity among type 2 DM female subjects aged 35-65 yrs attending Diabetic clinic of a tertiary care hospital in Kerala. |
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| Detailed Description | The BCC model consisted of 1.an audio visual module imparting knowledge about DM, its complications, advantages of PA in Diabetes control, how to include more PA in routine life style 2. pamphlets.All these were standardised. Physical activity was measured using international physical activity questionnaire validated(responsiveness& reliability) for our cultural activity.IPAQ covers four domains of physical activity: work-related,transportation, housework/gardening and leisure-time activity. PA data from the questionnaire were transformed into energy expenditure estimates as MET using published values. To calculate the weekly physical activity (MET-h /week), the number of hours dedicated to each activity class was multiplied by the specific MET score for that activity. follow up once in a month (4 times) measure incremental physical activity and reinforcement in each visit. Students t test was used to compare the experimental and control groups with respect to the incremental physical activity measured in calorie expenditure. It was found that the incremental physical activity(final-basal) measured in METS is significantly higher in intervention group. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care |
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| Condition ICMJE | Type 2 Diabetes Mellitus | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 86 | ||||
| Completion Date | October 2006 | ||||
| Primary Completion Date | July 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 30 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | India | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00690326 | ||||
| Other Study ID Numbers ICMJE | Physical activity RCT | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr. Rose Dvy.C, Assistant professor Dept. Physiology,Thiruvananthapuram Medical College | ||||
| Study Sponsor ICMJE | Thiruvananthapuram Medical College | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Thiruvananthapuram Medical College | ||||
| Verification Date | June 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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