| CTRI Number |
CTRI/2011/06/001839 [Registered on: 28/06/2011] Trial Registered Prospectively |
| Last Modified On: |
06/11/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral
Other (Specify) [Behaviour change intervention] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
A community-based cluster randomized control trial to study the effectiveness of an intervention to change dietary behavior among middle income households through culturally appropriate household (HH) and community level strategies |
|
Scientific Title of Study
|
Behavioral intervention for diet among middle-income households in rural Kerala |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| U1111-1121-9481 |
UTN |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Meena Daivadanam |
| Address |
Achutha Menon Center for Health Science Studies (AMCHSS), Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Trivandrum – 11, Kerala, India.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
09446173669 |
| Fax |
04712446433 |
| Email |
meenadaivadanam@live.in |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr K R Thankappan |
| Address |
Achutha Menon Center for Health Science Studies (AMCHSS), Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Trivandrum – 11, Kerala, India.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
04712524231 |
| Fax |
04712446433 |
| Email |
kavumpurathu@yahoo.com |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Dr Meena Daivadanam |
| Address |
Achutha Menon Center for Health Science Studies (AMCHSS), Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Trivandrum – 11, Kerala, India.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
09446173669 |
| Fax |
04712446433 |
| Email |
meenadaivadanam@live.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Meena Daivadanam |
| Address |
PhD Scholar, Achutha Menon Center for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum – 11, Kerala, India. Phone: 0471-2419364; Fax: 0471-2446433; Mobile: 9446173669; Email: meenadaivadanam@live.in |
| Type of Sponsor |
Other [Own funding (PhD study)] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Meena Daivadanam |
Chirayinkeezhu taluk, Trivandrum district, Kerala, India |
Achutha Menon Center for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum 11, Kerala, India
Thiruvananthapuram
|
09446173669
0471-2446433
meenadaivadanam@live.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum 11, Kerala, India. Phone: 04712520256, 04712520257 Fax 04712446433 Email anoop@sctimst.ac.in |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Households and randomly selected healthy respondents between 25 and 45 years. Preventive intervention to modify the risk for chronic non-communicable diseases (NCDs) and its diet-related risk factors. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Health Education |
Health Education in the form of information on recommended levels of intake of fruit, vegetables, salt, sugar and oil per person per day. In addition, information booklets on importance of healthy diet will be provided. |
| Intervention |
Sequential stage-matched behavioral intervention |
Sequential stage-matched behavioral intervention for 1 year that includes counseling, awareness classes and stage-specific strategies to change household procurement and individual intake of fruits, vegetables, salt, sugar and oil. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) Only individuals from middle-income households in selected panchayats of Rural Chirayinkeezhu taluk
2) Adult males and females 25 – 45 years of age with no self-reported diabetes or hypertension, mental illness or other serious illness
3) Adult males and females 25 – 45 years of age with self-reported deranged lipids but not on medical treatment
4) Residing in Chirayinkeezhu taluk for at least 6 months prior to baseline survey
|
|
| ExclusionCriteria |
| Details |
1) Individuals from low and high income households
2) Takes two or more meals away from home on most weekdays
3) Definite plans of migration during the study period
4) Known case of hypertension (HT), Diabetes (DM) or any individual with deranged lipids (DL) on treatment or history of other serious illness
5) Known case of mental illness / other serious illness
6) Pregnant women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Difference in F&V consumption of the healthy individual - Baseline to endline
2. Difference in F&V procured by the household - Baseline to endline
|
Baseline to endline - 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Proportion of households showing shift in stages of behaviour change at 4, 8 and 12 months compared to baseline
2. Assess which change processes were more effective and which were ineffective in bringing about behaviour change
3. Difference in oil consumed by the household from baseline to end-line
4. Difference in salt consumed by the household: from baseline to end-line
5. Difference in sugar consumed by the household from Baseline to end-line
|
Baseline to endline - 1 year |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
10/07/2011 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Brief Summary
|
This is a cluster randomized community-based study to test the effectiveness of a set of culturally appropriate sequential stage-matched household (HH) and community level strategies to change dietary behavior (in terms of both household procurement and individual consumption) among middle income households with respect to five dietary elements namely, fruits, vegetables, salt, sugar and oil when compared to the control arm who will receive health education on recommended levels of intake of these five elements as well as information booklets.
The primary objective is to test the effectiveness of the sequential stage-matched strategies to increase the prevalence of adequate fruit (F) and vegetable (V) intake (5 servings=2F+3V) by 20% from baseline in the intervention arm compared to the control arm.
The secondary (minor) objectives are:
1) To increase household procurement of F&V and decrease household consumption of salt, sugar and oil from baseline
2) To assess whether sequential stage-matched interventions can assist individuals to progress through the different stages of behavior change at subsequent follow-up points (4, 8 and 12 months) compared to baseline
3) To assess barriers and facilitating factors for dietary change behavior in terms of change processes with particular reference to gender and socio-economic status |
