The Effect of a Peer-modeled Complex Behavioural Change Intervention on the Cardio-metabolic Health of Women in Mbarara City, Uganda
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- KU Leuven
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Central adiposity
研究概览
简要总结
The goal of this clinical trial is to learn about the effects of a peer-led behavioural change intervention on the cardio-metabolic health of women aged 18 to 49 years. The main question it aims to answer is:
-Does a peer-led behavioural change intervention improve the cardio-metabolic health of women aged 18 to 49 years?
Researchers will compare food literacy, physical literacy, and awareness with a comparison arm that receives only information on doable actions to improve cardio-metabolic health in a small booklet.
The participants will:
- Participants in the intervention arm will have group activities on food literacy, physical literacy and awareness for 3 months of the active phase of the intervention.
- The participants in the intervention arm will be followed up with a phone call in between the active phase of the intervention.
- At the beginning of the study, the participants in the comparison arm will receive a small booklet with inforgraphics on ways to improve their cardio-metabolic health, with no further contact.
- All the participants will not be contacted in any form for the next 3 months after the active phase of the intervention.
- The participants will be measured for their waist circumference, fat mass, blood pressure, lipid and glucose levels, and arterial stiffness.
- The participants will also be assessed for physical activity levels, dietary intake, body size preferences, self-efficacy, social support, self-monitoring, and self-esteem.
详细描述
Theoretical framework The proposed study utilises the Social Cognitive Theory (SCT). The SCT, widely utilised, shows the dynamic interaction among a person's behaviour (skills, practice and self-efficacy), environmental determinants (social norms, influence on others and access in the community), and personal factors (knowledge, expectations and attitudes), and how those factors change or affect one another. The current study targets personal factors and individual behaviours, given their importance, including their changeability and literature-based relevance.
In line with the SCT cognitive factors, the awareness component aims to increase knowledge of cardio-metabolic health and risk factors, health expectancies from behaviour change practices, and attitudes towards body size perception in relation to health.
Physical literacy comprises elements such as motivation and confidence, physical competence, and knowledge and understanding of the value of, and responsibility for, engaging in physical activities for life. Physical literacy aims to increase knowledge and understanding of the health benefits of engaging in daily physical activity as an integral part of one's life choices. This is based on the behavioural factors of skills, practice and self-efficacy of the SCT.
Food literacy is a collection of inter-related knowledge, skills and behaviour required to empower in the five core domains; i) planning for food through making feasible decisions; ii) select of quality food; iii) food preparation of tasty and hygienic meals; iv) and eat food to meet individual needs and v) ability to screen information from different platforms on healthy eating. Food literacy aims to increase knowledge and skills for consuming and preparing healthy meals that improve cardio-metabolic health. To achieve food literacy, we base it on the behavioural factors of skills, practice, and self-efficacy within the SCT.
The study's primary objective is to assess the effect of a complex behavioural change intervention on the central adiposity of women of reproductive age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The peer models who will deliver the intervention in the community.
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women of reproductive age (WRA; 18 to 49 years).
- •With central obesity measured as a waist circumference of > 80cm and up to 88 cm.
- •They should consent and be willing to follow a 3-month active intervention and a 3-month post-intervention follow-up.
- •They should be residents of Mbarara City.
- •They should either speak English or Runyakitara/Runyankore.
排除标准
- •Pregnant and lactating for six months.
- •Taking anti-diabetic or hypertension medication.
- •Physically incapacitated to stand for measurements or speak
研究组 & 干预措施
Intervention arm
This arm will have 77 participants. They will receive the 3 components of the behavioural intervention, including i) awareness, ii) physical literacy, and iii) food literacy. The awareness will include group discussion sessions and the use of info-graphics with information on cardio-metabolic health, cultural beauty perceptions, illustrations on the use of a waist circumference, and doable actions for optimal health. Physical literacy will include group sessions focused on increasing physical activity in daily life. Food literacy will include group sessions on food demonstrations, meal planning, food choices, the plate model, and information to increase intake of fruits and vegetables and reduce intake of fatty snacks.
干预措施: A peer-modelled behavioural change intervention (Behavioral)
A comparison arm
This arm will only receive a booklet with information and illustrations on benefits and recommendations for increasing fruit and vegetable intake and physical activity, as well as vegetable recipes and practical tips to eat more fruit and vegetables and engage in more physical activity. This booklet has already been published and utilised in a previous study within our study unit
结局指标
主要结局
Central adiposity
时间窗: At baseline, endline after 3 months of the study intervention's active phase, and at 6 months post-intervention.
Central adiposity will be assessed using a waist circumference of less than 80 cm. This is a cut-off based on the IDF guidelines for central adiposity and metabolic syndrome, a key parameter for cardio-metabolic health.
次要结局
- Increase in physical activity levels(Assessment at baseline, endline after 3 months of the intervention and at 6 months post-intervention.)
- Increase in fruit and vegetable intake(At baseline, 3 months at endline of the active phase of the intervention and at 6 months post-intervention)
- Fasting blood glucose levels(Measure at baseline, endline after 3 months of the intervention, and post-intervention at 6 months)
- HDL cholesterol(At baseline, after 3 months of the active phase of the intervention, and at 6 months post-intervention)
- Triglycerides(At baseline, after 3 months of the active phase of the intervention and at 6 months post-intervention.)
- Blood pressure(At baseline, after 3 months of the active phase of the intervention and at 6 months post-intervention)
- Fat mass(At baseline, 3 months after the active phase of the intervention and at 6 months post-intervention)
- Body mass index(At baseline, 3 months after the active phase of the intervention and at 6 months post-intervention.)
- Arterial stiffness(At baseline, 3 months after the active phase of the intervention, and at 6 months post-intervention.)
- Food literacy(At baseline, endline after 3 months of the active phase of the intervention, and at 6 months post-intervention)
- Body size preference(Assessment at baseline, endline after 3 months of the intervention and at 6 months post-intervention.)
- Body dissatisfaction(At baseline, 3 months after the active phase of the intervention and at 6 months post-intervention.)