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

NCT00690326 | Completed Results DMC

• 1 other identifier: NCT00690326
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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-

1. 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. 2.Vigorous intensity PA \>6.5METs-Person will not be able to carry out conversation. running, aerobics for 20 mins

Conditions

Physical Inactivity; Type2 Diabetes Mellitus

Keywords

physical activity; Diabetes Mellitus type2; Behavioral change communication; Household physical activity; Female Diabetic patients

Outcome Measures

Primary Outcomes (2)

• Total Physical Activity Log Means and Geometric Means With Standard Deviation in Intervention and Control Groups After Intervention.

  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

  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 Outcomes (1)

• Glycosylated Haemoglobin(HbA1c)

  At the end of 4 months

Other Outcomes (1)

• Number of Participants in Pre Contemplation and Action Stages in Intervention& Control Groups After Intervention

  after 4 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

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'

Interventions

Behavioral change communication model(BCC) to promote physical activity BEHAVIORAL

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.

Also known as: pamphlet, placebo

Intervention group

pamphlet-The printed pamphlet,'Physical activity:To control blood sugar/ Diabetes Mellitus' OTHER

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.

Also known as: pamphlet, placebo

control group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: Females aged 30 to 65 years with Diabetes Mellitus type 2 attending diabetic clinic Out Patient clinic at Diabetic Clinic OP
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• females 30to 65yrs. with type-2 Diabetes Mellitus.
• Attending Diabetic clinic at a tertiary level hospital(medical college Thiruvananthapuram)
• on oral hypoglycemics

You may not qualify if:

• only one patient from one family
• H/o myocardial infarction
• nephropathy
• autonomic neuropathy
• severe limiting osteo arthritis
• pregnancy
• Mental incompetence

Sponsors & Collaborators

• Thiruvananthapuram Medical College: lead

Study Sites (1)

Diabetic clinic,Thiruvananthapuram medical college hospital

Thiruvananthapuram, Kerala, 695011, India

Location

Related Publications (22)

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  PMID: 10705560 RESULT

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  RESULT

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  PMID: 15249533 RESULT

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  RESULT

• Irwin ML, Mayer-Davis EJ, Addy CL, Pate RR, Durstine JL, Stolarczyk LM, Ainsworth BE. Moderate-intensity physical activity and fasting insulin levels in women: the Cross-Cultural Activity Participation Study. Diabetes Care. 2000 Apr;23(4):449-54. doi: 10.2337/diacare.23.4.449.

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  PMID: 10535433 RESULT

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  PMID: 11985936 RESULT

• Albright A, Franz M, Hornsby G, Kriska A, Marrero D, Ullrich I, Verity LS. American College of Sports Medicine position stand. Exercise and type 2 diabetes. Med Sci Sports Exerc. 2000 Jul;32(7):1345-60. doi: 10.1097/00005768-200007000-00024.

  PMID: 10912903 RESULT

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• Ainsworth BE, Haskell WL, Whitt MC, Irwin ML, Swartz AM, Strath SJ, O'Brien WL, Bassett DR Jr, Schmitz KH, Emplaincourt PO, Jacobs DR Jr, Leon AS. Compendium of physical activities: an update of activity codes and MET intensities. Med Sci Sports Exerc. 2000 Sep;32(9 Suppl):S498-504. doi: 10.1097/00005768-200009001-00009.

  PMID: 10993420 RESULT

• Patel A, Edwards TC, Jones G, Liddle AD, Cobb J, Garner A. Metabolic equivalent of task scores avoid the ceiling effect observed with conventional patient-reported outcome scores following knee arthroplasty. Bone Jt Open. 2023 Mar 1;4(3):129-137. doi: 10.1302/2633-1462.43.BJO-2022-0119.R1.

  PMID: 37051845 RESULT

• Wani RT. Socioeconomic status scales-modified Kuppuswamy and Udai Pareekh's scale updated for 2019. J Family Med Prim Care. 2019 Jun;8(6):1846-1849. doi: 10.4103/jfmpc.jfmpc_288_19.

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• Sharma R. Revised Kuppuswamy's Socioeconomic Status Scale: Explained and Updated. Indian Pediatr. 2017 Oct 15;54(10):867-870. Epub 2017 Aug 26.

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• pacompendium.com

  RESULT

• Hagstromer M, Oja P, Sjostrom M. The International Physical Activity Questionnaire (IPAQ): a study of concurrent and construct validity. Public Health Nutr. 2006 Sep;9(6):755-62. doi: 10.1079/phn2005898.

  PMID: 16925881 RESULT

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

We could have continued intervention for longer period and monitored dose of oral hypoglycemics and body weight.The time limit allowed for the study was the main constraint.

Results Point of Contact

• Title: Dr.Ramdas Pisharody
• Organization: Clinical Epidemiology Research and Training Centre,Medical College,Thiruvananthapuram,India

ramdaspisharody@gmail.com

04712448825

Study Officials

• Rose D Chakkola, MD MPhil

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor in Physiology ,Govt medical college,Kerala.MPhil in Clinical epidemiology student

Study Record Dates

• First Submitted: June 2, 2008
• First Posted: June 4, 2008
• Study Start: July 2, 2006
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: April 15, 2026
• Results First Posted: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)