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临床试验/NCT07345754
NCT07345754招募中不适用

Women Supporting Women Using Local Solutions to Improve Infant and Young Child Feeding and Care Practices in Punjab, Pakistan

University of British Columbia1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年10月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Weight

研究概览

简要总结

This project aims to reduce child malnutrition in Pakistan by building on local strengths and practical community solutions. The project focuses on children 7-23 months of age. The investigators will aim to recruit young children between 7-15 months of age, giving the youngest children priority over older children so that participants may be followed longitudinally over 6 and 12 months. The project supports participants for six months through learning, practice, and regular follow-up. The work begins with community sensitization events, where local families learn about healthy feeding for young children through group discussions, visuals, and printed materials. These sessions build awareness, encourage community support, and prepare families for the main intervention.

The core of the project is a 28-day behaviour change program. In the first two weeks, mothers and children take part in daily "Hearth" sessions, which are interactive, home-like meetings that teach practical feeding, hygiene, and caregiving skills using local foods. In the next two weeks, mothers apply learned skills at home while being visited regularly by project staff, who provide support and monitor child growth. If children gain at least 400 grams, as recommended by WHO, families graduate to monthly check-ins; if not, families may repeat the 28-day cycle up to three times. This approach targets chronic malnutrition by supporting families in adopting sustainable caregiving practices rather than providing short-term aid.

Educational materials developed with community input support the learning process. Designed with visuals and minimal text, the materials are accessible to both literate and illiterate parents and are distributed widely to encourage shared responsibility for child health.

To measure success, the project uses surveys and growth measurements for both treatment and control groups. Surveys gather information about family demographics, feeding and hygiene behaviours, and health practices, while trained staff measure children's height and weight at regular intervals. The data will help determine whether the intervention improves children's nutritional status and caregiving practices.

Ultimately, the project seeks to empower families and communities to use local resources and knowledge to support healthier child growth. The project combines community engagement, hands-on learning, and scientific evaluation to promote lasting change in how families feed, nurture, and care for young children.

详细描述

This study is rooted in an asset-based approach grounded in the belief that, in every community, certain individuals demonstrate uncommon behaviours that enable solutions to prevalent and seemingly intractable problems. During the formative research phase, supported by the Community Advisory Committee (CAC), the objective was to identify strategies that are already feasible within the community of Rahim Yar Khan, Pakistan, and to amplify these strategies to the wider community during the intervention phase. The intervention comprises two major components: community sensitization and a 28-day behaviour change period.

The intervention targets households with moderately malnourished children between 7 and 15 months of age and will follow and support these households for a period of six months. Consent will be obtained from both parents via thumbprint or signature. Severely malnourished children, regardless of study arm, will be referred to local health facilities for appropriate care. Households in the control group will continue with usual feeding and caregiving practices.

COMMUNITY SENSITIZATION OVERVIEW

Community sensitization events will be held in each intervention cluster. These events will introduce the project to local families and provide information on complementary feeding for children aged 6-23 months. Sessions will be delivered using a town-hall format with small group activities. Key messages, supported by visuals and printed materials from the 28-day behaviour change program (described below), will be shared with the broader community. The objective of the community sensitization component is to raise awareness about the project, disseminate best practices related to complementary feeding, and promote community buy-in, as well as neighbourhood support for households participating in the 28-day behaviour change program.

28-DAY BEHAVIOUR CHANGE PRACTICE PROGRAM OVERVIEW

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
7 Months 至 15 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Eligible participants must meet all of the following conditions:
  • Child-Level Criteria:
  • While children in the intervention phase will range from ages 7-23 months, At the time of recruitment children will range from Ages: 7-15 months.
  • Priority will be given to younger children, aged 7-11 months, followed by 12-15 months to allow completion of the intervention and follow-up visits before the child turns 24 months of age, as complementary feeding refers to feeding practices between the ages of 6-24 months.
  • Moderate malnutrition, defined by: Weight-for-age Z-score between -2 and -3 standard deviations.
  • Household-Level Criteria:
  • Households will be eligible to participate if:
  • They meet the classification of very poor or poor (based on community-defined wealth stratification).
  • Have access to clean water and sanitation.
  • Food secure at time of recruitment, defined as:
  • On government assistant program or at least one adult has permanent employment, or two or more have temporary employment.
  • Ownership of at least one simple livestock (e.g., chicken, goat, or sheep) or express willingness to accept and care for livestock provided by the project team.
  • Access to a kitchen garden, or willingness to establish one with study support
  • Mother Eligibility Criteria:
  • The household is eligible only if the mother meets all of the following:
  • Mother is the primary caregiver for the Index Child (responsible for daily care, including supervision, bathing, and feeding).
  • Mother is alive and at least 18 years old.
  • Mother is currently breastfeeding the Index Child and willing to continue until the child reaches 2 years of age.
  • Mother expresses an interest in participating in the PD/Hearth program.
  • Mother agrees to attend up to three Hearth sessions.
  • Mother is willing and able to contribute to one of the following for Hearth sessions:
  • "Special" food items (e.g., apple, banana, carrot, chickpea, egg, garlic, lentils, rice, spinach, tomato, etc.), or
  • Other essential items (e.g., utensils, bowls, spoons, soap, nail cutter, towels, water, mat, salt, matchstick).
  • Mother provides permission for study follow-ups as outlined above.
  • Mother agrees to a full medical check-up for the Index Child at the nearest public health facility, including a one-time hematocrit finger-prick test (Hb test).
  • Mother provides informed consent via thumbprint or written signature.

排除标准

  • Child-Level Exclusions:
  • Children who are Severely malnourished, mildly underweight or of normal weight.
  • Children with Physical disabilities: difficulty in seeing, hearing, picking up small objects with his/her hand.
  • Children with chronic illnesses that may interfere with normal growth (based on past or current medical history):
  • Malabsorption
  • Chronic Kidney Disease
  • Inflammatory Bowel Disease
  • Congenital Heart Disease
  • Endocrine Disorders (e.g., hypothyroidism, growth hormone deficiencies)
  • Chronic Respiratory Diseases (e.g., asthma, lung diseases)
  • Congenital or Acquired Immunodeficiency, and Neurological Disorders
  • Household-Level Exclusion:
  • Households who do not meet the inclusion criteria.

研究组 & 干预措施

Intervention arm

Experimental

The intervention arm will participate in a 28-day behaviour change program consisting of two-week cycles of Hearth sessions followed by two weeks of home visits to reinforce and practise the newly learned behaviours. Before starting the program, each index child will be referred to a local health clinic for a medical assessment and confirmation of immunization. They will receive vitamin A supplementation and deworming treatment in accordance with national protocol, if required. The intervention arm will undergo the same evaluations as the control arm, including baseline and 6-month follow-up surveys, as well as monthly anthropometric measurements.

干预措施: 28-day Behavioural Change Program (Behavioral)

Control arm

No Intervention

This arm will not participate in the 28-day behaviour change program and will not not undergo a health facility-based assessment at baseline. The evaluations for this arm will include baseline and follow-up surveys, and monthly anthropometric measurements for up to 6 months. This group will continue to receive routine care from lady health workers (LHWs) and access health services as usual.

结局指标

主要结局

Weight

时间窗: At baseline; Hearth Days 1, 13, 28; During monthly home visits; End-Survey after 6 months

Index Child's weight will be measured in Kilogram(Kg) and will be used to assess the Index child's nutritional status.

Weight-for-age Z-score

时间窗: At baseline; Hearth Days 1, 13, 28; During monthly home visits; End-Survey after 6 months

Nutritional status of Index child will classify as (1) severely underweight, (2) moderate underweight, (3) mild underweight, (4) well-nourished or normal weight using weight-for-age Z-score as below. Severely underweight if weight-for-age Z-score \<-3 SD of the median. Moderate underweight if weight-for-age Z-score between -2 SD and -3 SD. Mild underweight if weight-for-age Z-score between -1 SD and -2 SD. Normal weight if weight-for-age Z-score between -1 SD and +1 SD.

次要结局

  • Length(At baseline and 6 months post-intervention)
  • Height-for-age Z-score(At baseline and 6 months post-intervention)
  • Mid-upper arm circumference (MUAC)(At baseline and 6 months post-intervention)
  • Weight-for-Height Z-Score(At baseline and 6 months post-intervention)
  • MINIMUM MEAL FREQUENCY 6-23 MONTHS (MMF)(At baseline and 6 months post-intervention)
  • MINIMUM DIETARY DIVERSITY 6-23 MONTHS (MDD)(At baseline and 6 months post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rosemin Kassam

Professor

University of British Columbia

研究点 (1)

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