Diet ModificationNCT03639402
Cardiovascular Health Promotion Among Nepalese Mothers With Young Children (HARDIC Trial)
A study testing Health education classes in people with Diet Modification and Physical Activity, run by Göteborg University.
Trial summary
Nutritional transition toward a high-fat and high-energy diet, decreasing physical activity level, and poor knowledge about cardiovascular health contribute to a rising burden of cardiovascular disease in low-income countries such as Nepal. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diet Modification, Physical Activity, Health Behavior
- What is being tested?
- Health education classes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,276 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mothers with children 1-9 years old
Who cannot join
- Mothers with hearing or mental disorders
- Mothers with mentally ill children or children whose health condition required a special diet and physical regimen
- Mothers who had lived in the community for only 2-3 months for seasonal work (eg, in brick kilns).
About this study
Official title: Protocol for Community-based Trial Among Nepalese Mothers With Young Children: Health Promotion Regarding Diet and Physical Activity
Nutritional transition toward a high-fat and high-energy diet, decreasing physical activity level, and poor knowledge about cardiovascular health contribute to a rising burden of cardiovascular disease in low-income countries such as Nepal. Dietary and physical activity behaviors are formed early in life and influenced by family, particularly by mothers in the social context of Nepal. This is a community-based trial with health promotion intervention targeting mothers with young children regarding diet and physical activity. The intervention is designed based on the peer education approach. All mothers having children 1-9 years old living in study area are eligible for the participation in the trial. One of the two communities within the study site is randomly assigned as intervention arm and other as control arm. Selected local peer mothers from intervention arm are trained by research team regarding heart healthy diet and physical activity. In turn, peer mothers are conducting education classes to others local mothers living around them. Baseline and follow-up assessment of the intervention is covering mothers own knowledge, attitude and practice (KAP) regarding diet and physical activity and behavior of their children as perceived by mothers. Intention to treat analysis and per protocol analysis is used in analysis to detect significant differences between intervention and control group participants at baseline and follow-up. Difference in difference statistical analysis is chosen to evaluate real impact of the intervention in the community. Such community based intervention can further contribute to developing a policy that can be scaled-up to a national level.
Read the detailed description
HARDIC project, includes needs assessment, development, and implementation of an intervention in the community, and also assesses impact. HARDIC trial is a community-based, randomized, controlled trial on diet and physical activity to promote heart health.
The studies is Jhaukhel-Duwakot Health Demographic Surveillance site (JD-HDSS), which consists of two villages-Jhaukhel and Duwakot-in the mid-hills of the Bhaktapur district, 13 kilometers outside Kathmandu, the capital of Nepal.
Baseline assesment to explore mothers' KAP regarding diet and physical activity is planned before intervention. Applying randomization (lottery method) Duwakot community is selected as intervention arm and Jhaukhel as control arm. Each community in Nepal is divided into nine administrative clusters (wards). To minimize contamination bias, the investigators selected five wards in Duwakot that did not border the control arm. The control arm includes all nine wards in Jhaukhel. HARDIC intervention is based on the concept of peer education for which 55 local peer mother from different wards of intervention arm are recruited with help of local female community health volunteers.
The intervention consists of two rounds. Selected peer mothers are divided into two groups and are trained by research team for 4 hours per day for 6 consecutive days. Training consists of interactive lectures, practical and demonstration sessions, discussions, group activities, practice sessions, and assignments. The peer mothers learn about communication skills and practiced using learning materials such as flipcharts. Additionally, home assignments for the 1-month gap between Rounds 1 and 2 is planned.
By the end of the training period, all peer mothers suppose to interact with neighbouring eligible mothers regarding the objectives of the intervention and accumulate a list of approximately 10 fellow mothers who are willing to participate in the intervention (educational classes given by peer mothers).
With the help of supervisors, peer mothers are preparing schedule for two 1-1.5-hour health education classes per week. Within 2 weeks after completing Round 1, each peer mother should conduct four health education classes for fellow mothers of their neighborhood. The health educational classes are based on the same modules that are used in the peer mothers' training and use the developed flipcharts, posters, and manuals for teaching purposes.
Round 2 is planned as providing recapitulation of the modules learned in Round 1 as well as discussion of the home assignments that peer mothers shall be given. Peer mothers follow same pattern when they teach fellow mothers.
Follow-up study is planned for both intervention and control arms in 3 months after completion of the intervention.
Mothers' KAP responses are scored and should be analyzed as continuous variables, calculated the median (IQR), and compared the intervention arm with control and KAP median (IQR) in the intervention arm at baseline and follow-up. Statistical Package for the Social Sciences (SPSS), version 23.0 (IBM, Armonk, New York, USA) shall be used for data management and analysis.
Actual impact of the intervention on mothers' KAP regarding diet and physical activity should be assessed using Difference in difference statistical approach from a linear regression model.
- Being tested
- Health education classes
- Keywords
- Diet, Physical activity, Attitude, Knowledge, Practice, Cardiovascular disease, Mothers, Peer education
- Medical subject headings
- Motor Activity, Health Behavior, Behavior, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education classesBehavioural
Also called HARDIC trial
Community empowerment through involvement of local mothers (peer mothers) for dissemination of education regarding health diet and physical activity to others eligible mothers in the community (fellow mothers).
| Study group | Role | What they receive |
|---|---|---|
| Health education classes | Experimental | Intervention consist of 2 rounds. Round 1: Locally selected mothers who have children 1-9 years old are trained by research team (peer mothers). Peer mothers conduct 4 education classes each for approximately 10 eligible mothers in their neighbourhood (fellow mothers).
Round 2: After one month gap one meeting for recapitulation and feedback is conducted by research team for peer mothers. Similarly, peer mothers conduct one meeting with fellow mothers. Receives: Behavioral: Health education classes |
| No health education classes | No intervention | Community is exposed to health-related information, which is provided by the regular health system of Nepal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
Change in median of mothers' KAP scores regarding diet and physical activity
Measured: 3 months
Secondary outcomes (1)
Secondary outcome
Change in median of children's behavior scores regarding diet and physical activity as perceived by their mothers
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study startAug 2016
- Primary completionFeb 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet ModificationStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- one community is randomized as intervention arm, another community as control arm
- Masking
- None (open label)
- Enrolment
- 1,276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalia Oli, PhD, Principal investigator, Kathmandu Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639402
- Sponsor's protocol ID
- HARDIC trial Nepal
- Status last verified
- Aug 2018
- First submitted
- 16 Aug 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De- identified individual participant data will be made available. Data for baseline survey are available as a supplementary material in the publication in the PLOS One. Remaining data will be available after publishing the trial results.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Community-based Trial Among Nepalese Mothers With Young Children: Health Promotion Regarding Diet and Physical Activity
- ClinicalTrials.gov ID
- NCT03639402
- Acronym / sponsor ID
- HARDIC trial Nepal
- Keywords
- Diet, Physical activity, Attitude, Knowledge, Practice, Cardiovascular disease, Mothers, Peer education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,276 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nutritional transition toward a high-fat and high-energy diet, decreasing physical activity level, and poor knowledge about cardiovascular health contribute to a rising burden of cardiovascular disease in low-income countries such as Nepal. Dietary and physical activity behaviors are formed early in life and influenced by family, particularly by mothers in the social context of Nepal. This is a community-based trial with health promotion intervention targeting mothers with young children regarding diet and physical activity. The intervention is designed based on the peer education approach. All mothers having children 1-9 years old living in study area are eligible for the participation in the trial. One of the two communities within the study site is randomly assigned as intervention arm and other as control arm. Selected local peer mothers from intervention arm are trained by research team regarding heart healthy diet and physical activity. In turn, peer mothers are conducting education classes to others local mothers living around them. Baseline and follow-up assessment of the intervention is covering mothers own knowledge, attitude and practice (KAP) regarding diet and physical activity and behavior of their children as perceived by mothers. Intention to treat analysis and per protocol analysis is used in analysis to detect significant differences between intervention and control group participants at baseline and follow-up. Difference in difference statistical analysis is chosen to evaluate real impact of the intervention in the community. Such community based intervention can further contribute to developing a policy that can be scaled-up to a national level.
Detailed description
HARDIC project, includes needs assessment, development, and implementation of an intervention in the community, and also assesses impact. HARDIC trial is a community-based, randomized, controlled trial on diet and physical activity to promote heart health.
The studies is Jhaukhel-Duwakot Health Demographic Surveillance site (JD-HDSS), which consists of two villages-Jhaukhel and Duwakot-in the mid-hills of the Bhaktapur district, 13 kilometers outside Kathmandu, the capital of Nepal.
Baseline assesment to explore mothers' KAP regarding diet and physical activity is planned before intervention. Applying randomization (lottery method) Duwakot community is selected as intervention arm and Jhaukhel as control arm. Each community in Nepal is divided into nine administrative clusters (wards). To minimize contamination bias, the investigators selected five wards in Duwakot that did not border the control arm. The control arm includes all nine wards in Jhaukhel. HARDIC intervention is based on the concept of peer education for which 55 local peer mother from different wards of intervention arm are recruited with help of local female community health volunteers.
The intervention consists of two rounds. Selected peer mothers are divided into two groups and are trained by research team for 4 hours per day for 6 consecutive days. Training consists of interactive lectures, practical and demonstration sessions, discussions, group activities, practice sessions, and assignments. The peer mothers learn about communication skills and practiced using learning materials such as flipcharts. Additionally, home assignments for the 1-month gap between Rounds 1 and 2 is planned.
By the end of the training period, all peer mothers suppose to interact with neighbouring eligible mothers regarding the objectives of the intervention and accumulate a list of approximately 10 fellow mothers who are willing to participate in the intervention (educational classes given by peer mothers).
With the help of supervisors, peer mothers are preparing schedule for two 1-1.5-hour health education classes per week. Within 2 weeks after completing Round 1, each peer mother should conduct four health education classes for fellow mothers of their neighborhood. The health educational classes are based on the same modules that are used in the peer mothers' training and use the developed flipcharts, posters, and manuals for teaching purposes.
Round 2 is planned as providing recapitulation of the modules learned in Round 1 as well as discussion of the home assignments that peer mothers shall be given. Peer mothers follow same pattern when they teach fellow mothers.
Follow-up study is planned for both intervention and control arms in 3 months after completion of the intervention.
Mothers' KAP responses are scored and should be analyzed as continuous variables, calculated the median (IQR), and compared the intervention arm with control and KAP median (IQR) in the intervention arm at baseline and follow-up. Statistical Package for the Social Sciences (SPSS), version 23.0 (IBM, Armonk, New York, USA) shall be used for data management and analysis.
Actual impact of the intervention on mothers' KAP regarding diet and physical activity should be assessed using Difference in difference statistical approach from a linear regression model.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- one community is randomized as intervention arm, another community as control arm
| Arm | Type | Receives |
|---|---|---|
| Health education classes | Experimental | Behavioral: Health education classesIntervention consist of 2 rounds. Round 1: Locally selected mothers who have children 1-9 years old are trained by research team (peer mothers). Peer mothers conduct 4 education classes each for approximately 10 eligible mothers in their neighbourhood (fellow mothers). Round 2: After one month gap one meeting for recapitulation and feedback is conducted by research team for peer mothers. Similarly, peer mothers conduct one meeting with fellow mothers. |
| No health education classes | No intervention | –Community is exposed to health-related information, which is provided by the regular health system of Nepal |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Mothers with children 1-9 years old
Key exclusion criteria (3 listed)
- Mothers with hearing or mental disorders
- Mothers with mentally ill children or children whose health condition required a special diet and physical regimen
- Mothers who had lived in the community for only 2-3 months for seasonal work (eg, in brick kilns).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health education classesAlso: HARDIC trialCommunity empowerment through involvement of local mothers (peer mothers) for dissemination of education regarding health diet and physical activity to others eligible mothers in the community (fellow mothers). | Behavioural | Health education classes |
Primary outcome
Primary outcome
Time frame: 3 months
Change in median of mothers' KAP scores regarding diet and physical activity
1 secondary outcome
Secondary outcome
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Individual participant dataSharing planned: Yes. De- identified individual participant data will be made available. Data for baseline survey are available as a supplementary material in the publication in the PLOS One. Remaining data will be available after publishing the trial results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalia Oli, PhD principal investigator
Kathmandu Medical College
Questions about this trial
What is this clinical trial studying?
A study testing Health education classes in people with Diet Modification and Physical Activity, run by Göteborg University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2018.