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Development of the Salt Reduction and Efficacy Maintenance Program in Indonesia
Last registered on April 24, 2016

Pre-Trial

Trial Information
General Information
Title
Development of the Salt Reduction and Efficacy Maintenance Program in Indonesia
RCT ID
AEARCTR-0001204
Initial registration date
April 24, 2016
Last updated
April 24, 2016 9:35 PM EDT
Location(s)
Primary Investigator
Affiliation
School of Nursing, Hasanuddin University, Indonesia
Other Primary Investigator(s)
PI Affiliation
Division of Health Sciences, Graduate School of Medical Sciences Kanazawa University
PI Affiliation
Division of Health Sciences, Graduate School of Medical Sciences Kanazawa University
Additional Trial Information
Status
Completed
Start date
2014-10-27
End date
2015-01-29
Secondary IDs
Abstract
We conducted a randomized control trial to examine the effects of Salt Reduction Efficacy Maintenance (SREM), in reducing the salt intake of older people with high blood pressure. A total of 51 participants in Indonesia were randomly assigned to a control group (n=17), Salt Reduction Training (SRT) group (n=17), or SREM as an intervention groups (n=17). The SREM group was given educational training and a maintenance meeting. The knowledge, attitude toward self-care, and self-efficacy of the SREM group were significantly increased one week after training and maintained one week after a maintenance meeting. The SRT group also showed significant effects for same variables; however, a rebound of food salt concentration was observed one week after the maintenance meeting. No significant improvement was found in the control group. In the maintenance meeting, SREM participants reported positive effects of salt reduction and applying it in different ways based on who cooks at their houses. The SREM program was effective for maintaining knowledge, attitude, and self-efficacy of salt reduction practices and could be integrated into community nursing intervention for older people with hypertension/prehypertension.
External Link(s)
Registration Citation
Citation
Irwan, Andi Masyitha , Mayumi Kato and Kazuyo KItaoka. 2016. "Development of the Salt Reduction and Efficacy Maintenance Program in Indonesia ." AEA RCT Registry. April 24. https://doi.org/10.1257/rct.1204-1.0.
Former Citation
Irwan, Andi Masyitha et al. 2016. "Development of the Salt Reduction and Efficacy Maintenance Program in Indonesia ." AEA RCT Registry. April 24. https://www.socialscienceregistry.org/trials/1204/history/7904.
Experimental Details
Interventions
Intervention(s)
Conceptual framework
Self-care intervention combined three different theories to increase self-care and self-efficacy of elderly patients with hypertension or prehypertension, namely Dorothea Orem’s 1993 self-care deficit theory (Taylor and Renpenning, 2011; Fawcett, 1995), Albert Bandura’s 1970s self-efficacy theory (Bandura, 1994), and Martha Tyler John’s 1988 geragogy theory (Glendenning, 2000; Thomas, 2007). The conceptual framework of the intervention is shown in Figure 1.
Salt Reduction Training (SRT)
To improve participants’ knowledge, attitudes, and low-salt intake while maintaining high self-efficacy, a two-day educational training, Salt Reduction Training (SRT),was conducted weekly. Each 90-minute session with 8–10 participants was followed by a 15 minute break. This training applied learning methods derived from geragogy and self-efficacy concepts. Geragogy is defined as a process involved in stimulating and helping the elderly to study (John,1988).
In SRT, the geragogy concept is used with frequent repetition and evaluation of key points in hypertension self-care, including demonstrating how to measure daily salt intake and prioritizing important skills. Self-efficacy concepts were utilized by stressing that maintaining a low-salt diet is easy, changing negative thoughts about salt and hypertension, and reinforcing positive attitudes during discussion. In addition, to motivate participants, trained elderly role models who had implemented low-salt diets shared their experiences about the benefits and ease of implementing a low-salt diet. Participants were given time to ask questions. To master the concepts of a low-salt diet, participants and researchers cooked a low-salt menu together during the second day of training. The majority of training information and leaflets were in pictures, including the leaflets “You Can Deal with High Blood Pressure by Reducing Salt Intake.”
Salt Reduction and Efficacy Maintenance (SREM) program
One month after training, participants in the SREM group attended a 90-minutefollow-up meeting, called a maintenance meeting, designed to help them overcome difficulties and challenges they faced in applying a low-salt diet. Members in the SRT group received only the initial two-day training. Table 1 gives an overview of the intervention given to the SRT and SREM groups. During the maintenance meeting, participants shared their progress, benefits, and challenges of following a low-salt diet. Role models were invited again for interactive discussions with participants. As opposed to the mainly one-way communication by role models during the SRT, in the maintenance meeting, both role models and participants had a lively discussion because they had implemented a low-salt diet together. Any solutions and progress reported in this meeting were reinforced. Participants were given a chance to adjust their low-salt diet targets based on difficulties and solutions offered by other participants.
Intervention Start Date
2014-10-27
Intervention End Date
2015-01-29
Primary Outcomes
Primary Outcomes (end points)
At the end of intervention, participants in SREM group had improved their knowledge, attitudes, and low-salt intake while maintaining high self-efficacy,
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
A randomized controlled trial (RCT) assigned participants to one of three groups: a control group and two kinds of intervention groups—the Salt Reduction Training (SRT) group and the Salt Reduction and Efficacy Maintenance (SREM) group.
Experimental Design Details
Randomization Method
51 pieces of paper put in the envelope and researcher randomly took out the papers and divide into 3 groups.
Randomization Unit
51 eligible participants were assigned to either the control group (n=17), the Salt Reduction Training (SRT) group (n=17), or the Salt Reduction and Efficacy Maintenance group (n=17). Subjects in the control group received only typical MHC checkups.
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
2 area in Tammua sub-district, Makassar, South Sulawesi, Indonesia
Sample size: planned number of observations
273 elderly people lived in Tammua.
Sample size (or number of clusters) by treatment arms
51 older people
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Kanazawa University Ethics Committe
IRB Approval Date
2015-10-09
IRB Approval Number
546-1
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers