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Cardiovascular Health Promotion Among Nepalese Mothers With Young Children (HARDIC Trial)

NCT03639402 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1276

Last updated 2018-08-21

No results posted yet for this study

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. 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.

Conditions

  • Diet Modification
  • Physical Activity
  • Health Behavior
  • Health Promotion

Interventions

BEHAVIORAL

Health education classes

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).

Sponsors & Collaborators

  • Göteborg University

    lead OTHER

Principal Investigators

  • Natalia Oli, PhD · Kathmandu Medical College

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-02-28
Completion
2017-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03639402 on ClinicalTrials.gov