The Effectiveness of 'A BCC Model' in Promoting Physical Activity Among Females With Type 2 Diabetes Mellitus:A Randomised Controlled Trial
Phase: NA
Conditions: Physical Inactivity, Type2 Diabetes Mellitus
Sponsor: Thiruvananthapuram Medical College

 
NCT00690326 
12/04/2026 
 
 
1.Title 
Effectiveness of ‘Behavioural Change Communication Model’ in Promoting Physical 
Activity Among Females with Type 2 Diabetes Mellitus: A Randomized Controlled Trial. 
 
2. Introduction 
Rationale of the Study: The global prevalence of Type 2 Diabetes Mellitus (T2DM) is rising 
rapidly, far surpassing previous predictions. A central pathological feature of T2DM is 
insulin resistance, which is significantly driven by physical inactivity. While physical 
activity (PA) is a low-cost, effective non-pharmacological intervention, it remains 
underutilised, particularly among females in certain social contexts. In South India, females 
are highly affected by diabetes and often follow sedentary lifestyles. This study addresses the 
need for tailored behavioural change strategies to promote a context-specific physical activity 
culture. 
3. Review of Literature 
• 
Global Burden: The number of people with diabetes was projected to reach 300 
million by 2025 but already hit 537 million by 2021. 
• 
Role of PA: Exercise improves glucose tolerance, upregulates insulin receptors, and 
reduces insulin resistance. 
• 
Behavioural Change: The Transtheoretical Model (TTM) provides a framework 
for behaviour change through five stages: pre-contemplation, contemplation, 
preparation, action, and maintenance. 
• 
Interventions: Stage-matched materials and motivational readiness assessments can 
create cost-effective interventions for individuals prepared to initiate change. 
4. Materials & Methods (Methodology) 
• 
Research Question: Will a “behavioural change communication model” 
implemented in a Diabetic Clinic OP among females with Type 2 DM be effective in 
making them more physically active?. 
• 
Aim: To evaluate the effectiveness of a BCC model in promoting physical activity 
among female T2DM patients. 
• 
Objectives:  
o Primary: To measure the increase in physical activity in Metabolic 
Equivalent Task (MET) scores using a PA questionnaire. 
o Secondary: To assess changes in HbA1C levels, knowledge of diabetes and 
PA, and the stage of behaviour change. 
• 
Hypothesis: A standardized BCC model will improve physical activity, knowledge, 
and the stage of behaviour change in the intervention group compared to a control 
group receiving only pamphlets. 
• 
Study Design: Randomized controlled trial (RCT). 
• 
Setting: Diabetic Clinic outpatient department at a government tertiary care hospital 
in South India. 
• 
Sampling:  
o Sample Size: 86 females (43 in the intervention group, 43 in the control 
group). 
o Inclusion Criteria: Females with Type 2 DM aged 30–65 years. 

o Exclusion Criteria: Patients with complications (nephropathy, H/O 
myocardial infarction), those advised against exertion, and multiple patients 
from the same family. 
o Sampling Procedure: Consecutive recruitment followed by block 
randomization using RALLOC software. 
• 
Methods:  
o Data Collection: Trained assistants use an interview schedule to collect 
demographic, clinical, and PA data (IPAQ-long form). 
o Intervention: The BCC model includes a 30-minute PA promotion video, 
pamphlets, and recall/report of PA over four monthly visits. 
o Outcome Measurement: Total and specific PA under four domains 
(occupational, domestic, transportation, leisure) measured in MET scores and 
converted to calories/day. 
5. Plan of Analysis 
• 
Statistical Software: SPSS. 
• 
Analysis Methods:  
• 
Data distribution will be analysed. If normal distribution, parametric methods will be 
used. If skewed distribution, normalisation of data and non-parametric methods will 
be considered. 
 Baseline physical activity difference will be adjusted for comparing the 
control and intervention groups. 
 
• 
Sample Size Calculation: Based on a 95% CI and a pooled standard deviation (18) 
from a pilot study of 15 subjects 
 
 
• 
sample size calculation  
Estimating the difference between two means  
SD from pilot study-18  
 
n=z*-a/2(2sp*)/d* 
 
• 
2-tailed  
• 
Precision-10)  
• 
Desired CI-95%  
• 
no. in one arm=39  
• 
Expecting 5% drop outs  
• 
39/(1-.05)2=43  
 
 
Sampling Method  
 
Consecutive sampling from Diabetic clinic OP for 5 consecutive Fridays based on screening 
questionnaire with inclusion and exclusion criteria 
 
 
 
 
 
 

 
 
 
 
 
6. Policy Implications 
The study highlights that motivation and reinforcement are effective strategies for fostering 
self-management responsibilities in T2DM patients. Implementing such behavioural models 
in clinical settings can help bridge the gap between patient awareness and actual lifestyle 
changes. 
7. References 
References should be formatted in Vancouver style. 
8. Annexures 
• 
Instrument of Measurement: International Physical Activity Questionnaire (IPAQ) 
short form 
• 
Knowledge & SOC Questionnaires: 7-question knowledge set and Stage of Change 
(SOC) assessment. 
• 
Ethical Clearance: Obtained on 17/05/2006. 
• 
Consent Forms: Provided in English and local languages.