Behavioral Change Communication (BCC) to Promote Physical Activity Among Females With Type 2 Diabetes Mellitus Attending Diabetic Clinic

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Behavioral Change Communication to Promote Physical Activity Among Females With Type 2 Diabetes Mellitus Attending Diabetic Clinic.

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Behavioral change communication to promote physical activity
* Behavioral: Behavioral change communication to promote physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: females 30to 65yrs. with type-2 Diabetes Mellitus. Attending Diabetic clinic at a tertiary level hospital(medical college Thiruvananthapuram) on oral hypoglycemics Exclusion Criteria: only one patient from one family H/o myocardial infarction nephropathy autonomic neuropathy severe limiting osteo arthritis pregnancy Mental incompetence

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>treatment type: behavioral(lifestyle counseling) treatment name: behavioral change communication to promote physical activity | Behavioral: Behavioral change communication to promote physical activity<br>* treatment type: behavioral (lifestyle counseling) treatment name: behavioral change communication to promote physical activity<br>|
| Placebo Comparator: B<br>Arm B given placebo comparator ie pamphlets | Behavioral: Behavioral change communication to promote physical activity<br>* Arm B given placebo comparator ie pamphlet Audiovisual module Physical activity frequency questionnaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incremental physical activity |  | at the end of 4 months-October | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycosylated hemoglobin |  | At the end of 4 months -October | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, Diabetes mellitus, Behavioral change communication, Household physical activity