Trial Outcomes & Findings for Behavioral Change Communication for Physical Activity Among Females With Type2 Diabetes Mellitus (NCT NCT00690326)
NCT ID: NCT00690326
Last Updated: 2026-04-15
Results Overview
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
COMPLETED
NA
86 participants
After 4 months trial period
2026-04-15
Participant Flow
Ethical clearance got on 17/5/2006.Pilot study conducted. participants were selected on 2/6/2006,16/6/2006,23/6/2006,30/6/2006.Block randomised with Random allocation software into intervention and control group. Started intervention from 7/7/2006 till end of October 2006 conducted in Diabetic clinic out patient Thiruvananthapuram medical college.
No wash out/ run-in/ transition approaches following participant enrollment.
Participant milestones
| Measure |
Intervention Group
treatment type:Behavioral
treatment name: Behavioral change communication model including a physical activity promotion video 30 minutes duration implemented at Diabetic clinic op at 4 consecutive visits and a printed pamphlet-Physical activity :To control blood sugar
|
Control Group
given placebo comparator the printed pamphlets-Physical activity:To control blood sugar
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
43
|
|
Overall Study
COMPLETED
|
43
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Behavioral Change Communication for Physical Activity Among Females With Type2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Intervention Group
n=43 Participants
treatment type:Behavioral change
treatment name: Behavioral change communication model including Physical activity promotion video (30 minutes duration implemented at Diabetic op at 4 consecutive visits) , a pamphlet and recall and documenting of last week physical activity using PA interview schedule by the interviewer at op.
participants-Diabetes Mellitus-type2 females aged 30-65yrs attending diabetic clinic OP selected by means of London school of Hygiene cardiovascular Questionnaire fit for moderate and severe physical activity and block randomisation done into intervention and control group.
|
Control Group
n=43 Participants
given the printed pamphlets- Physical activity:To control blood sugar. Diabetic-type2 females aged 30-65yrs attending diabetic clinic OP selected using London school of Hygiene cardiovascular Questionnaire ' fit for moderate and severe physical activity . Block randomisation done into intervention and control group.
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
43 Participants
n=193 Participants
|
43 Participants
n=193 Participants
|
86 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Age, Continuous
|
52.53 years
STANDARD_DEVIATION 7.294 • n=193 Participants
|
51.63 years
STANDARD_DEVIATION 7.728 • n=193 Participants
|
52.08 years
STANDARD_DEVIATION 7.484 • n=386 Participants
|
|
Race/Ethnicity, Customized
Asian,South indian, Kerala
|
43 participants
n=193 Participants
|
43 participants
n=193 Participants
|
86 participants
n=386 Participants
|
|
Region of Enrollment
India
|
43 participants
n=193 Participants
|
43 participants
n=193 Participants
|
86 participants
n=386 Participants
|
|
physical activity before intervention calories/day
total physical activity
|
179.304 calories/day
STANDARD_DEVIATION 16.79 • n=193 Participants
|
185.38 calories/day
STANDARD_DEVIATION 25.06 • n=193 Participants
|
182.34 calories/day
STANDARD_DEVIATION 30 • n=386 Participants
|
|
physical activity before intervention calories/day
household physical activity l
|
80.3 calories/day
STANDARD_DEVIATION 19 • n=193 Participants
|
66.9 calories/day
STANDARD_DEVIATION 22 • n=193 Participants
|
73.6 calories/day
STANDARD_DEVIATION 29 • n=386 Participants
|
|
physical activity before intervention calories/day
leisure time physical activity
|
16.57 calories/day
STANDARD_DEVIATION 3.2 • n=193 Participants
|
25.4 calories/day
STANDARD_DEVIATION 20.0 • n=193 Participants
|
20.9 calories/day
STANDARD_DEVIATION 20.2 • n=386 Participants
|
|
physical activity before intervention calories/day
occupational physical activity
|
3.01 calories/day
STANDARD_DEVIATION 3.3 • n=193 Participants
|
15.07 calories/day
STANDARD_DEVIATION 5.7 • n=193 Participants
|
9 calories/day
STANDARD_DEVIATION 6.5 • n=386 Participants
|
|
physical activity before intervention calories/day
transportational physical activity
|
85.9 calories/day
STANDARD_DEVIATION 3.8 • n=193 Participants
|
83.3 calories/day
STANDARD_DEVIATION 5.1 • n=193 Participants
|
84.6 calories/day
STANDARD_DEVIATION 6.4 • n=386 Participants
|
|
physical activity before intervention calories/day
Total physical activity in log mean
|
5.18 calories/day
STANDARD_DEVIATION 0.094 • n=193 Participants
|
5.215 calories/day
STANDARD_DEVIATION 0.121 • n=193 Participants
|
5.198 calories/day
STANDARD_DEVIATION 0.109 • n=386 Participants
|
|
bodyweight in kilogram
|
58.94 kilogram
STANDARD_DEVIATION 7.33 • n=193 Participants
|
60.31 kilogram
STANDARD_DEVIATION 7.45 • n=193 Participants
|
59.63 kilogram
STANDARD_DEVIATION 7.39 • n=386 Participants
|
|
HbA1C(glycosylated hemoglobin)
|
6.4047 gram /100ml
STANDARD_DEVIATION 0.853 • n=193 Participants
|
6.6349 gram /100ml
STANDARD_DEVIATION 1.0094 • n=193 Participants
|
6.5198 gram /100ml
STANDARD_DEVIATION 0.9312 • n=386 Participants
|
|
knowledge score
|
1.28 score
STANDARD_DEVIATION 1.06 • n=193 Participants
|
1.06 score
STANDARD_DEVIATION 0.25 • n=193 Participants
|
1.174 score
STANDARD_DEVIATION 0.3817 • n=386 Participants
|
PRIMARY outcome
Timeframe: After 4 months trial periodPopulation: We got 86 patients during the study period, got consent \& done block randomised allocation into 2 arms.So sample size in one arm=43 each
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
Outcome measures
| Measure |
Treatment gp.Receiving BCC
n=43 Participants
treatment type:Behavioral change using a physical activity promotion video showing importance of physical activity in controlling blood sugar and methods to increase physical activity in daily routines of life.
treatment name: Behavioral change communication.30 minutes duration implemented at Diabetic clinic outpatient waiting room for 4 consecutive visits.
Behavioral change communication to promote physical activity: treatment type: behavioral (lifestyle counseling)
treatment name: behavioral change communication to promote physical activity
|
Control gp.Receiving Only Pamphlet
n=43 Participants
participants were distributed with placebo comparator, the "printed pamphlets" giving informations regarding importance of physical activity in controlling blood sugar at the diabetic clinic op
Behavioral change communication to promote physical activity: control group given placebo comparator ie pamphlet
Audiovisual module Physical activity frequency questionnaire
|
|---|---|---|
|
Total Physical Activity Log Means and Geometric Means With Standard Deviation in Intervention and Control Groups After Intervention.
|
216.07 log calories/day
Standard Deviation 1.13
|
201.47 log calories/day
Standard Deviation 1.19
|
PRIMARY outcome
Timeframe: at the end of 4 months-OctoberPopulation: physical activity measured under house hold, transportational ,leisure time and occupational domains.
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
Outcome measures
| Measure |
Treatment gp.Receiving BCC
n=43 Participants
treatment type:Behavioral change using a physical activity promotion video showing importance of physical activity in controlling blood sugar and methods to increase physical activity in daily routines of life.
treatment name: Behavioral change communication.30 minutes duration implemented at Diabetic clinic outpatient waiting room for 4 consecutive visits.
Behavioral change communication to promote physical activity: treatment type: behavioral (lifestyle counseling)
treatment name: behavioral change communication to promote physical activity
|
Control gp.Receiving Only Pamphlet
n=43 Participants
participants were distributed with placebo comparator, the "printed pamphlets" giving informations regarding importance of physical activity in controlling blood sugar at the diabetic clinic op
Behavioral change communication to promote physical activity: control group given placebo comparator ie pamphlet
Audiovisual module Physical activity frequency questionnaire
|
|---|---|---|
|
Domains of Total Physical Activity(Calories/Day) After Intervention in Intervention Group and Control Group
occupational PA
|
2.03 calorie/day
Standard Deviation 5.05
|
4.48 calorie/day
Standard Deviation 8.94
|
|
Domains of Total Physical Activity(Calories/Day) After Intervention in Intervention Group and Control Group
household PA
|
59.3 calorie/day
Standard Deviation 3.32
|
30.6 calorie/day
Standard Deviation 6.30
|
|
Domains of Total Physical Activity(Calories/Day) After Intervention in Intervention Group and Control Group
transportation PA
|
72.9 calorie/day
Standard Deviation 2.25
|
46.6 calorie/day
Standard Deviation 5.16
|
|
Domains of Total Physical Activity(Calories/Day) After Intervention in Intervention Group and Control Group
leisuretimePA
|
0 calorie/day
Standard Deviation 0
|
0 calorie/day
Standard Deviation 0
|
SECONDARY outcome
Timeframe: At the end of 4 monthsPopulation: Fasting blood of each patient was taken at the beginning \&at the end of study and HbA1C was estimated in intervention and control group
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
Outcome measures
| Measure |
Treatment gp.Receiving BCC
n=43 Participants
treatment type:Behavioral change using a physical activity promotion video showing importance of physical activity in controlling blood sugar and methods to increase physical activity in daily routines of life.
treatment name: Behavioral change communication.30 minutes duration implemented at Diabetic clinic outpatient waiting room for 4 consecutive visits.
Behavioral change communication to promote physical activity: treatment type: behavioral (lifestyle counseling)
treatment name: behavioral change communication to promote physical activity
|
Control gp.Receiving Only Pamphlet
n=43 Participants
participants were distributed with placebo comparator, the "printed pamphlets" giving informations regarding importance of physical activity in controlling blood sugar at the diabetic clinic op
Behavioral change communication to promote physical activity: control group given placebo comparator ie pamphlet
Audiovisual module Physical activity frequency questionnaire
|
|---|---|---|
|
Glycosylated Haemoglobin(HbA1c)
|
6.0465 percentage
Standard Deviation 0.6974
|
6.0881 percentage
Standard Deviation 0.8984
|
OTHER_PRE_SPECIFIED outcome
Timeframe: after 4 monthsPopulation: number of participants analysed are same as participants assigned 43 in intervention and 43 in control groups measure type is number of participants in pre contemplation and action stage.
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.
Outcome measures
| Measure |
Treatment gp.Receiving BCC
n=43 Participants
treatment type:Behavioral change using a physical activity promotion video showing importance of physical activity in controlling blood sugar and methods to increase physical activity in daily routines of life.
treatment name: Behavioral change communication.30 minutes duration implemented at Diabetic clinic outpatient waiting room for 4 consecutive visits.
Behavioral change communication to promote physical activity: treatment type: behavioral (lifestyle counseling)
treatment name: behavioral change communication to promote physical activity
|
Control gp.Receiving Only Pamphlet
n=43 Participants
participants were distributed with placebo comparator, the "printed pamphlets" giving informations regarding importance of physical activity in controlling blood sugar at the diabetic clinic op
Behavioral change communication to promote physical activity: control group given placebo comparator ie pamphlet
Audiovisual module Physical activity frequency questionnaire
|
|---|---|---|
|
Number of Participants in Pre Contemplation and Action Stages in Intervention& Control Groups After Intervention
pre contemplation
|
5 Participants
|
25 Participants
|
|
Number of Participants in Pre Contemplation and Action Stages in Intervention& Control Groups After Intervention
action
|
38 Participants
|
18 Participants
|
Adverse Events
Intervention Group
Control Group or Placebo Comparator Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr.Ramdas Pisharody
Clinical Epidemiology Research and Training Centre,Medical College,Thiruvananthapuram,India
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place