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

NCT03639402 | Completed

• 1 other identifier: HARDIC trial Nepal
• Study Type: interventional
• Target: 1,276
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Diet; Physical activity; Attitude; Knowledge; Practice; Cardiovascular disease; Mothers; Peer education

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  Change in median of mothers' KAP scores regarding diet and physical activity

  3 months

Secondary Outcomes (1)

• Secondary outcome

  1 year

Study Arms (2)

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.

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

Interventions

Health education classes BEHAVIORAL

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).

Also known as: HARDIC trial

Health education classes

Eligibility Criteria

• Gender Eligibility Details: The aim of the project is to address diet and physical activity habits among young children to decrease possible risk of CVD in the future. In Nepal, mothers are mostly responsible for their family's food environment and also for shaping their children's lifestyle. Hence we enrolled mothers who have children 1-9 years old for the trial.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Mothers with children 1-9 years old

You may not qualify if:

• 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).

Sponsors & Collaborators

• Göteborg University: lead

MeSH Terms

Conditions

Motor Activity; Health Behavior; Behavior; Cardiovascular Diseases

Study Officials

• Natalia Oli, PhD

  Kathmandu Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: one community is randomized as intervention arm, another community as control arm

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 21, 2018
• Study Start: August 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 21, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available within 6 months after study completion
• Access Criteria: Data access requests will be reviewed by external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.