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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Behavioral change communication to promote physical activity
Behavioral change communication to promote physical activity
Sponsored by
Thiruvananthapuram Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes Mellitus focused on measuring physical activity, Diabetes mellitus, Behavioral change communication, Household physical activity

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Diabetic clinic,Thiruvananthapuram medical college hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

treatment type: behavioral(lifestyle counseling) treatment name: behavioral change communication to promote physical activity

Arm B given placebo comparator ie pamphlets

Outcomes

Primary Outcome Measures

incremental physical activity

Secondary Outcome Measures

glycosylated hemoglobin

Full Information

First Posted
June 2, 2008
Last Updated
June 3, 2008
Sponsor
Thiruvananthapuram Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT00690326
Brief Title
Behavioral Change Communication (BCC) to Promote Physical Activity Among Females With Type 2 Diabetes Mellitus Attending Diabetic Clinic
Acronym
BCC
Official Title
Behavioral Change Communication to Promote Physical Activity Among Females With Type 2 Diabetes Mellitus Attending Diabetic Clinic.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Thiruvananthapuram Medical College

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
physical activity, Diabetes mellitus, Behavioral change communication, Household physical activity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
treatment type: behavioral(lifestyle counseling) treatment name: behavioral change communication to promote physical activity
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Arm B given placebo comparator ie pamphlets
Intervention Type
Behavioral
Intervention Name(s)
Behavioral change communication to promote physical activity
Intervention Description
treatment type: behavioral (lifestyle counseling) treatment name: behavioral change communication to promote physical activity
Intervention Type
Behavioral
Intervention Name(s)
Behavioral change communication to promote physical activity
Intervention Description
Arm B given placebo comparator ie pamphlet Audiovisual module Physical activity frequency questionnaire
Primary Outcome Measure Information:
Title
incremental physical activity
Time Frame
at the end of 4 months-October
Secondary Outcome Measure Information:
Title
glycosylated hemoglobin
Time Frame
At the end of 4 months -October

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rose D Chakola, MD MPhil
Organizational Affiliation
CERTC-Clinical epidemiology research&training centre,Trivandrum medical college
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabetic clinic,Thiruvananthapuram medical college hospital
City
Thiruvananthapuram
State/Province
Kerala
ZIP/Postal Code
695011
Country
India

12. IPD Sharing Statement

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