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

NCT ID: NCT00690326

Last Updated: 2008-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2006-10-31

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.

Conditions

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Type 2 Diabetes Mellitus

Keywords

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physical activity Diabetes mellitus Behavioral change communication Household physical activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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A

treatment type: behavioral(lifestyle counseling)

treatment name: behavioral change communication to promote physical activity

Group Type EXPERIMENTAL

Behavioral change communication to promote physical activity

Intervention Type BEHAVIORAL

treatment type: behavioral (lifestyle counseling)

treatment name: behavioral change communication to promote physical activity

B

Arm B given placebo comparator ie pamphlets

Group Type PLACEBO_COMPARATOR

Behavioral change communication to promote physical activity

Intervention Type BEHAVIORAL

Arm B given placebo comparator ie pamphlet

Audiovisual module Physical activity frequency questionnaire

Interventions

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Behavioral change communication to promote physical activity

treatment type: behavioral (lifestyle counseling)

treatment name: behavioral change communication to promote physical activity

Intervention Type BEHAVIORAL

Behavioral change communication to promote physical activity

Arm B given placebo comparator ie pamphlet

Audiovisual module Physical activity frequency questionnaire

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Thiruvananthapuram Medical College

OTHER

Sponsor Role lead

Responsible Party

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Assistant professor Dept. Physiology,Thiruvananthapuram Medical College

Principal Investigators

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Rose D Chakola, MD MPhil

Role: PRINCIPAL_INVESTIGATOR

CERTC-Clinical epidemiology research&training centre,Trivandrum medical college

Locations

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Diabetic clinic,Thiruvananthapuram medical college hospital

Thiruvananthapuram, Kerala, India

Site Status

Countries

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India

Other Identifiers

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Physical activity RCT

Identifier Type: -

Identifier Source: org_study_id