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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN16622685 |
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Date of registration:
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27/06/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effectiveness of a community based lifestyle modification program to reduce risk factors associated with hypertension
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Scientific title:
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Effectiveness of a community based healthy lifestyle promotion on risk factors for hypertension in an urban slum population: a quasi experimental study |
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Date of first enrolment:
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30/05/2013 |
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Target sample size:
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342 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN16622685 |
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Study type:
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Interventional |
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Study design:
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Prospective quasi-experimental community based study (Prevention)
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Phase:
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Countries of recruitment
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Kenya
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Beatrice
Olack |
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Address:
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Kenya Medical Research institute
Center for Global Health Research
Off Mbagathi Road
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Nairobi
Kenya |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Aged 35 years and over
2. Living in the selected villages within the slum
3. Above optimal blood pressure (Systolic Blood Pressure =120 mmHg and Diastolic Blood Pressure =80mmHg)
4. Willing and able to participate fully in all aspects of the intervention
Exclusion criteria: 1. Medical condition or disability that hinders engagement
2. Females who are pregnant (self reported)
3. Participants planning to leave the area prior to the anticipated study end date
4. Unwillingness to give informed consent
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension
Circulatory System
Hypertension
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Intervention(s)
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Kibera slum is one of the largest slums in Nairobi, Kenya. The slum is further subdivided 13 geographic demarcations called villages. The intervention and comparator villages are allocated by convenience and separated by three other villages. The intervention village is selected as it is involved in active population based surveillance and has a designated referral health facility. The comparator village lacks a surveillance system and primary health facility thus represents the usual standard of care.
Participants in the intervention village are invited to participate in lifestyle modification sessions at a community venue, conveniently located for study participants. Participants in the intervention village are invited to attend 14 weekly group classes (sessions) over 16 weeks (intensive phase) followed by home based biweekly individual sessions for 8 weeks (maintenance phase). Two sessions (5 and 13) within the 16 weeks are used as make up sessions. Structure and content of the weekly classes are adapted from established non pharmacologic Interventions like Healthy Eating and Lifestyle Program (HELP) with additional home based individual sessions. The weekly group sessions are conducted by trained community health workers (CHWs) and each session lasts one to one half hours. The key components of the intervention are creating awareness on the risk factors associated with hypertension, motivating the participants to engage in healthy eating, increased physical activity via brisk walking and identifying symptoms of stress and the ways to cope with it. The content of the lifestyle program is underpinned in behaviour change approaches focusing on patients motivation, social support and self efficacy for gradual adoption and maintenance of healthy lifestyle. The trained CHWs talk about hypertension and its risk factors, optimal diet based on Dietary approaches to Stop Hypertension (DASH) diet. Contents of food pyramid, role of different foods, reading food labels, rec
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Primary Outcome(s)
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Mean Systolic Blood Pressure (SBP) is measured using an automated OMRON Digital Blood Pressure Monitor at baseline, 3 and 6 months.
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Secondary Outcome(s)
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1. Targeted dietary intake (intake of fruits and vegetables, sodium and saturated fats) is measured through self-reporting in a 24 hour dietary recall at baseline, 3 and 6 months
2. Physical activity is measured using the International Physical Activity Questionnaire (IPAQ) at baseline, 3 and 6 months
3. Mean body mass index calculated from individual weight and height measures obtained by trained field staff following standard procedures at baseline, 3 and 6 months
4. Perceived Stress measured by a questionnaire on perceived stress using Cohens scale at baseline, 3 and 6 months
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Source(s) of Monetary Support
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Wellcome Trust
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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