Protocol for Community-based Trial Among Nepalese Mothers With Young Children: Health Promotion Regarding Diet and Physical Activity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,276
- 主要终点
- Primary outcome
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Mothers with children 1-9 years old
排除标准
- •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).
研究组 & 干预措施
Health education classes
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.
干预措施: Health education classes (Behavioral)
No health education classes
Community is exposed to health-related information, which is provided by the regular health system of Nepal
结局指标
主要结局
Primary outcome
时间窗: 3 months
Change in median of mothers' KAP scores regarding diet and physical activity
次要结局
- Secondary outcome(1 year)