Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04899648 |
| Other study ID # |
STUDY00012777 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 30, 2021 |
| Est. completion date |
December 30, 2021 |
Study information
| Verified date |
May 2021 |
| Source |
University of Washington |
| Contact |
Julia Dettinger, MPH |
| Phone |
206-221-1041 |
| Email |
jcdettin[@]uw.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is an effectiveness-implementation study to assess the effectiveness of a peer-led
multi-component lifestyle program that will aim to lower BP among pre-hypertensive
individuals in Nepal. The program will aim to encourage weight loss, improve diet (using a
DASH diet), lower sodium intake, encourage only moderate alcohol intake among drinkers, and
encourage more physical activity through peers.
Description:
Hypertension is a serious medical condition and can increase the risk of heart, brain, kidney
and other diseases. It is a major cause of premature death worldwide, with upwards of 1 in 4
men and 1 in 5 women - over a billion people - having the condition. The burden of
hypertension is felt disproportionately in low- and middle-income countries, where two-thirds
of cases are found, largely due to increased risk factors in those populations in recent
decades Pre-hypertension, defined as systolic blood pressure (BP) of 120-139 mmHg or
diastolic BP of 80-89 mmHg, is a precursor to hypertension, and is associated with excess
morbidity and deaths from cardiovascular diseases (CVD). Hence, the reduction of BP to
optimal levels is a major public health priority. Although clinical trials have shown that
pharmacotherapy lowers BP among pre-hypertensives; it has been argued that pharmacotherapy is
not reasonable because the absolute risk in patients without other CVD risk factors is low
and pharmacotherapy is costly. Lifestyle modifications have proven to reduce BP, and are also
useful to prevent other chronic diseases. Major lifestyle modifications shown to lower BP
include weight loss; reduced sodium intake; regular aerobic physical activity; moderate
alcohol drinking; the Dietary Approach to Stop Hypertension diet - a diet rich in fruits,
vegetables, low-fat dairy products, potassium and calcium, and reduced dietary cholesterol,
saturated and total fats. Combinations of two or more lifestyle modifications may have even
better results. However, most of the studies have focused on one or two lifestyle
interventions and are tested in efficacy trials in a clinical setting. Therefore, there is a
major gap in the evidence for the effectiveness of a community-based multi-component
intervention on BP reduction. In addition, it is not clear how such an intervention would be
scaled up to the general population in low-and-middle-income countries, where the burden of
hypertension and CVD is the highest.
To address this gap, the investigators propose to conduct an effectiveness-implementation
study to assess the effectiveness of a peer-led multi-component lifestyle program that will
aim to lower BP among pre-hypertensive individuals in Nepal. The program will aim to
encourage weight loss, improve diet (using a DASH diet), lower sodium intake, encourage only
moderate alcohol intake among drinkers, and encourage more physical activity through peers.
Peer education can be as effective as using health professionals and is a cost-effective and
sustainable method for lifestyle modification. The peer-education approach is driven by
social learning theory, emphasizing credibility, role modeling, empowerment, and
reinforcement which contrasts with the delivery of lifestyle modification advice in the usual
clinical setting. While implementing the peer-led multi-component lifestyle intervention, the
investigators will collect information on factors affecting the delivery of the program and
the potential for scaled-up implementation in a real-world situation. The feasibility and
scalability of such programs in a real-life setting have not been studied. Besides, there are
three key challenges to manage pre-hypertension and hypertension in low-and middle-income
countries (LMICs). First, the pre-hypertensive population is considered non-diseased; hence
they are not in contact with the health system. Second, even though the efficacy of lifestyle
modifications has been proven, sustainable lifestyle modifications in the general population
are difficult to achieve due to the complexity of behavioral change. And third, the health
system in LMICs is already worn out due to the double burden of disease, and inadequate
financing and human resources. To address this massive challenge in an LMIC such as Nepal, a
cost-effective, community-based, sustainable, and scalable intervention is required. The
proposed study will establish evidence for a new model to lower BP in a community setting, by
determining the effectiveness of the peer-led multi-component program and informing the
success of implementation and scalability. This model will provide a valuable resource for
making recommendations and dissemination plans to implement and sustain lifestyle
interventions for lowering BP at the community level.
As such, the objectives of this study are:
1. To measure the effectiveness of the peer-led online multi-component lifestyle program on
reducing BP among the school employees of Dhulikhel and Banepa, Nepal. The investigators
will compare the change in systolic BP at twelve months between the peer-led
multi-component program group and usual care group using a community-based cluster
randomized control trial.
2. To measure the success of implementation and inform the scalability of the peer-led
multi-component lifestyle program. The investigators will evaluate (a) program adoption
by assessing changes in weight, diet, and physical activity behaviors among lifestyle
intervention participants; (b) fidelity to the program design by assessing activities of
peer-educators; and (c) acceptability of the program through (i) in-depth,
semi-structured interviews with lifestyle intervention program dropouts; and (ii) focus
group discussions with lifestyle intervention program participants.
3. To assess the impact of Covid-19 in hypertension management in context to the mental
wellbeing of hypertensive patients. The investigators will measure the impact of
Covid-19 on the mental health of a participant by measuring their anxiety and depression
levels through a questionnaire scale.
After identification of possible participants, the principal investigator and/or the research
assistants would make formal phone calls to the principals of the different educational
institutes to describe the research project. The principals of the educational institutes
are, then, sent information sheets and other informational materials regarding the project
via email. Then, after the approval of the principal, all the staff of the educational
institutions would be sent an information sheet and other information regarding the project.
After everyone is informed, a formal zoom or google meet appointment would be made with all
the staff of the educational institute. In this manner, the study participants would be
recruited and screened.
After 500 participants are selected from various educational institutes, their baseline
information will be collected which would include aspects of their demography, physical
activity, behavioral history like smoking and alcohol consumption, diet recall, mental health
status and anthropometric measurements. This will all take place in the first 3 months of the
study. All of this information will be collected via an online survey. As for the
anthropometric measurements, the investigators will have provided anthropometric instruments
like Digital Blood Pressure Machine, Digital Weighing Scale and Mechanical Measuring tape, to
each educational institute and also provided them with World Health Organization Guidelines
to use those instruments. Using the tools provided by the investigators, the study
participants will measure their anthropometric data themselves when they are in their
workplace. This information is then sent along with their other information while filling up
the online survey. After that, a computer-generated randomization process will be carried out
after which 250 participants will be selected for the intervention process.
Control Group: The remaining 250 Participants in the control group would not get exercise and
nutritional classes. But they will all get the study and educational material regarding
hypertension prevention after the end of the study.
Behavioral Classes: Participants (n=250) who are selected for the Behavioral Intervention
classes will be connected with the study team for 20 minutes video, 20 minutes of discussion
and 20 minutes of exercise every week. It would include 16 core sessions weekly during the
next four months of the program followed by 1 month maintenance sessions. Each core session
will last 1 hour every week. The audio and video of the sessions for some intervention groups
will be recorded. These Participants would also be reimbursed Nrs. 50 for the data package 16
times.
Peer Leader: Among the selected participants from the Intervention group, 10% of the
participants would be appointed peer leaders. The peer leaders will go through health
education classes via online platforms using various videos and presentations. The peer
leaders will also be paired with the professional health educators from the study staff and
will be informed about aspects like Diabetes Prevention Program Curriculum along with dieting
and exercise classes. Professional health educators will train the peer educators and provide
online supervision as well. The health educators will also assess the classes taken by peer
leaders to the rest of the participants and provide necessary feedback and motivation.
Behavior intervention will be comprised of extensive education sessions, group counseling and
goal setting and monitoring exercises based on the diabetes prevention program developed by
India Works. Peer Leader will conduct 16 session classes for the remaining participants in
the intervention group virtually. Peer Leader will measure Blood Pressure, Height and weight
of the Participants once a month from the Intervention Group.
Endline: This survey will be done for all the participants both in the control and
intervention groups. This would take 15-20 minutes. Some of the questions from the baseline
survey will be filled by the participants. (about daily activities, cigarettes and alcohol
intake) Height, weight, blood pressure will be accessed by themselves or their designated
peer leader. Questions about 24 hours diet, physical activities will be asked by the research
assistants through online platforms like zoom or viber.
