Behavioral Change Communication for Physical Activity Among Females With Type2 Diabetes Mellitus (RCT)

April 12, 2026 updated by: Dr.Rose Davy.C, Thiruvananthapuram Medical College

The Effectiveness of 'A BCC Model' in Promoting Physical Activity Among Females With Type 2 Diabetes Mellitus:A Randomised Controlled Trial

The marked discrepancy between predicted and actual prevalence of Type2 diabetes Mellitus (DM) with the actual cases rising earlier than expected, underscore the continuing relevance of tailored awareness and management strategies including physical activity(PA) to combat growing diabetes pandemic. Research is needed to develop effective programs that promote PA among female patients.Design& Method randomized controlled trial . 86 females 30 -65 years with type 2 DM attended Diabetic Clinic out patient at government tertiary care hospital,Kerala, south India from May to October 2006 including one week pilot study, participant selection, random allocation and intervention. Block randomized to intervention(43) and control(43) groups. Intervention-'Behavioral change communication model, including 30 mints 'PA promotion video',pamphlet and last week recall and report of PA using an interview schedule for 4 consecutive visits. measures- Total PA/day calculated in calorie from METs(metabolic equivalent score) , HbA1C, Total knowledge score, stage of change of behavior, the baseline PA under four domains in Metabolic Equivalent Task Score by interview using IPAQ(International Physiclal Activity Questionnaire) long form, body weight, occupation and source of water.

Physical activity recommendations according to Centres for Disease Control and Prevention Atlanta guide lines-

• Moderate intensity PA-30 mins./day(4-6.5 MET) for 5 days/week (brisk walk).Subjective assessment of moderate exercise -

  1. talk test-One who is on a moderate intensity level should be able to carry on a conversation comfortable while engagement in the activity.
  2. Vigorous intensity PA >6.5METs-Person will not be able to carry out conversation. running, aerobics for 20 mins

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sample size calculation

n=Z square x (1-∝/2 ) x[ 2 S square ] / d square.

Z square (0.975)

(alpha)∝=5% 1-∝/2 =7.5 S(pooled standard deviation from pilot study) =18,

  • Precision(d)=10(10% of mean)
  • Desired confidence interval(CI)-95% n(no. in one arm)=39

n adjusted for 5% drop out = 39/(1-0.05*1-0.05)=

39/(1 - 0.05)2=39/(0.95*0.95)=43 in one arm

Sampling Method

  • From Diabetic Clinic OP(out patient) for 4 consecutive fridays.
  • Average 80 patients attend per one OP clinic, of which 40 are females .
  • Recruited around 22 patients from one op following inclusion and exclusion criteria by two assistants using a Health screening questionnaire

Females with type2 Diabetes mellitus(T2DM) on oral hypoglycemics 30-65yrs excluding 2 patients from same family, those with nephropathy, history of myocardial infarction and those advised by doctor not to exert.

Timeline

  • Ethical committee clearance 17/5/06
  • Thesis protocol presented at Dept. of medicine and Diabetology 19/5/06
  • Pilot study-(15 patients) 26/5/2006
  • Patient screening &recruitment on 2/6,16/6,23/6,30/6.Informed about the program, collected address & telephone numbers.Intervention started from 7/7/2006.

Followed up for 4 visits ,once in a month, measured physical activity(PA) and reinforcement done with PA promotion video at each visit.

Pilot study:

The interview schedule questionnaires were administered by 2 interviewers in diabetic clinic for 15 random female patients. first interviewer asked the questions, the second interviewer also completed the same questionnaires in next visit. The completed questionnaires were compared using Kappa statistics for agreement regarding physical activity and knowledge score measurements. administration time was 25 to 30 minutes. Piloting helped to give training for the assistants in diabetic clinic in different elements of research process, to estimate the variability in measured Physical activity(PA) in metabolic equivalent task score (METs) to calculate sample size and to culturally adapt questions and to modify the questions.From the focussed group discussion the emergent theme was 'sedentary lifestyle among unemployed women'. Diabetic patient is helped by family members in routine life involving physical exertion.

Definitions

• Physical activity(PA)-Any bodily movement produced by skeletal muscles that result in expenditure of energy

Data collection Tools and collection procedure: IPAQ (international physical activity questionnaire)long form.

Data collection by 2 trained assistants the the assistants using the interview Schedule for PA promoting programme among females with T2DM The Section - I of the interview schedule collects Personal data, demographic data and Clinical Data relevant for this study. Section - II of the interview schedule collects Knowledge of DM & PA Under following domains Occupational, Domestic Transportation and Leisure time PA

Section - III The PA questionnaire-recall & report over a set period of time. It collects Moderate and heavy Physical activity frequency of the subject in minutes for past 1 week, converted into energy expenditure(kcal per min) using formula = 0.0175 kcal x METs x minutes (time of activity) x Body Weight (kg).From this calorie expenditure per day is calculated by dividing with actual number of days for which moderate or vigorous PA was done

METS of specific activities are given by 'compendium of Physical activities. Total PA score is calculated by adding 4 domains.

-recall &report over a set period of last one week. From total PA / week calories spent for one day calculated for comparison during analysis

Adverse event reporting -

Non systematic collection approach. enquired and collection approach. Reported or enquired if any, during preplanned visits.

  1. Physical injuries/ pain related to increased PA (muscle strains, joint pain
  2. Hypoglycemic episodes(dizziness)
  3. chest pain, excessive fatigue, or shortness of breath.
  4. Psychological effects - increased anxiety or stress related to the intervention.
  5. Any other unexpected health deterioration or complications triggered by the behavioral change program.

Secondary objectives

1.Blood glucose change 2 Knowledge of diabetes & physical activity 3 change of stage of behaviour using questionnaire 4 To evaluate the programme after the study by the participants

  1. measured by Glycosylated Haemoglobin(HbA1c)
  2. Change in knowledge score-A set of 7 questions before and after the study.(Arbitrary scoring given by the investigator (Score 1for each correct answer) regarding diabetes, insulin resistance and PA.

  3. Assessment of stage of behavioural change (SOC) using questionnaire

    • Precontemplation stage - not thinking about change( from sedentary to be physically active)
    • Contemplation- thinking about changing sedentary routine of life
    • Preparation- doing some physical activity
    • Action - doing enough physical activity
    • Maintenance - making physical activity a habit
    • Participants were invited by telephone and others by postal message.
    • Intervention- PA promotion video projection on 7/7,8/7,14/7/2016
    • Pamphlets for controll gp 15/7,21/7 blood collected for HbA1c.
    • 1st day projection arrangement done with the help of private arrangement, following 3 arrangements by Institute of Nova Kidney Foundation on recommendation from Dept. of Nephrology.
    • followed up till october.
    • visits were conveniently fixed on fridays- Diabetic clinic op During the last visit blood collected for HbA1c

Statistical analysis of Baseline measures and outcome measures done

Source of water- Understanding water sources helped in designing PA programs, as it is a substantial component of women's household PA.

Stage of Behaviour-

The HbA1c blood test- Knowledge score regarding T2DM, insulin resistance and PA. Scientific knowledge about role of physical activity in blood sugar regulation can change the attitude of behaviour regarding physical activity. This can motivate them from stage of pre & contemplation to action stage.

After intervention period-

Physical activity in METs converted to calorie expenditure.Added together and decided with number of days involved to get total calorie expenditure/day.

Comparison of "Total PA" after intervention period between the intervention and control group by ANCOVA 'adjusted for base line difference in PA'

Comparison of log transformed data of PA under different domains after intervention period between the intervention and control group.Geometric mean and variability were analysed

HbA1c by t test and mean change in knowledge score by Mann-Whitney Test after intervention.

Ordinal Regression analysis examining association of the grouping variable(intervention/control),knowledge score, and 'exposure to media' to dependent variable -the 'stages of change' -pre contemplation-stage1,contemplation-2,preparation-3,action-4, and maintenance-5

'Post test evaluation' after intervention period by all participants Q1-Did you enjoy the program? Q2-comments Q 3-Do you want to continue with the program ? Preferred day? Q4- What keeps you from not coming to a Physical Activity Promoting Programme regularly?

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Kerala
      • Thiruvananthapuram, Kerala, India, 695011
        • Diabetic clinic,Thiruvananthapuram medical college hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group

intervention for experimental arm : 'Behavioral change communication model' including a physical activity promotion video(30 explains showing how to be physical active in daily routines of life to control blood sugar) , pamphlet-'Physical Activity(PA) to control Diabetes Mellitus' and last week recall and report of PA using IPAQ-international questionnaire long form. Followed up for 4 months by 4 consecutive visits when video show repeated .

Video content- PA is scientifically proved to be effective in controlling diabetes mellitus and preventing long term complications of diabetes mellitus. 30 mints. continuous / 10 mints. intermittent brisk walks with a short gap in between - for 5 days is recommended.

Incorporate into daily life as occupational, household, transportation and leisure time PA. Carry water from well, scrub the floor with hands while on knee and hands, walk by getting down in the previous bus stop, use staircase, walk briskly swinging both hands.
Behavioral: Behavioral change communication model(BCC) to promote physical activity
Behavioral change communication is to promote physical activity among females with type2 diabetes mellitus of age 30 to 65 attending Diabetic clinic of a government hospital in south India.'Behavioral change communication model, including 30 mints 'PA promotion video', printed pamphlet-physical activity to control Diabetes Mellitus were given.Followed up by last week recall and report of PA using IPAQ-international questionnaire for 4 visits in 4 consecutive months.video show repeated each visit.
Other Names:
  • placebo
  • pamphlet
Placebo Comparator: control group
Participants of control group were distributed with placebo, the " printed pamphlets " physical activity to control Diabetes Mellitus.Followed up for 4 months by 4 consecutive visits in diabetic clinic OP. Measured each time their physical activity by last week recall and report of PA using IPAQ-international physical activity questionnaire and to report any adverse events related physical activity.
Other: pamphlet-The printed pamphlet,'Physical activity:To control blood sugar/ Diabetes Mellitus'

Control group participants were given only the printed pamphlets as placebo and followed up by last week recall and report of PA using (IPAQ-international questionnaire) for 4 visits in 4 consecutive months.

content of pamphlet- Physical activity has got equal importance as drugs and diet management in the treatment of diabetes mellitus. Diabetic patients should be aware of ABC HbA1C below7, B- BP control and C-Cholesterol control as recommended by ADA (American Diabetes Association). Physical Activity help to achieve these three. Physical activity decreases insulin resistance and increases the effectiveness of anti-diabetic drugs. Small tips to improve physical activity .Walk at least 15 minutes by getting down in the prevision bus stop. Use staircase instead of lift. Walk briskly swinging both hands) with a speed at which you sweat and heart rate raised to a level at which you can still talk comfortably.Do household works and gardening manually.

Other Names:
  • placebo
  • pamphlet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Physical Activity Log Means and Geometric Means With Standard Deviation in Intervention and Control Groups After Intervention.
Time Frame: After 4 months trial period
Occupational PA,House hold PA and transportation PA are calculated.They are added together and divided with number of days involved to calculate total physical activity in calory/day.Log transformation of data done.Higher value means better effectiveness of BCC.minimum 150 and maximum 374
After 4 months trial period
Domains of Total Physical Activity(Calories/Day) After Intervention in Intervention Group and Control Group
Time Frame: at the end of 4 months-October
After intervention, total physical activity in calories/day calculated by adding domains.Total PA=house hold physical activity+transportation PA+occupational PA+leisure time PA.Physical activity measured in minutes and then converted into metabolic equivalent task- score (MET score) using a "standardised" PA questionnaire for moderate & heavy physical activity for 1 week and calculated average for one day by dividing with number of active days.Sedentary activity measure two MET, light PA=3.5 MET.moderate PA= 4 to 6.5 MET are measured under four domains of PA and is converted into caloric expenditure using formula 0.0175 Kcal x MET of specific activity x body Weight. METS of specific activity is given by Compendium of physical activities- minimum zero calories and maximum 374.81 calories.Higher score means better outcome, better physically active due to effectiveness of intervention
at the end of 4 months-October

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycosylated Haemoglobin(HbA1c)
Time Frame: At the end of 4 months

Glycosylated haemoglobin (HbA1c)serves as the gold standard for monitoring long-term blood glucose level control, guiding therapeutic decisions, and predicting a person's risk for serious diabetes-related health problems.Physical activity will reduce insulin resistance and maintain a good glycemic control .t test done to compare HbA1C of intervention and control group after the intervention period.

gram percentage of HbA1C compared. Minimum value=4.5 gram%.maximum value=7.2and higher scores mean worse outcome indicating poor glycemic control and physical inactivity
At the end of 4 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants in Pre Contemplation and Action Stages in Intervention& Control Groups After Intervention
Time Frame: after 4 months

Assessment of stage of behavioral change (SOC) by interview(Trans theoretical model) using questionnaire.Recorded participant's motivation level on a 0 to 10 scale .

  • score 0-3 Precontemplation - not thinking about change(stage 1)
  • 4-6 =Contemplation stage thinking about change(stage 2)

  • 7= Preparation- doing some physical activity(stage 3)

    • 7 =Action - doing enough physical activity(stage 4)

Minimum is stage 1 and maximum is stage 5. Higher stage mean better outcome.
after 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thiruvananthapuram Medical College

Investigators

  • Principal Investigator: Rose D Chakkola, MD MPhil, CERTC-Clinical epidemiology research&training centre,Trivandrum medical college

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2006

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

June 2, 2008

First Submitted That Met QC Criteria

June 3, 2008

First Posted (Estimated)

June 4, 2008

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 12, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT00690326

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It is patient data, submitted to the university as part of fulfilment of degree

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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