Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04635332
Status:
COMPLETED
Last Update Posted:
2021-06-02
First Post:
2020-11-13
Brief Title:
Food Literacy and Physical Activity Intervention to Optimize Metabolic Health Among Women in Urban Uganda
Sponsor:
KU Leuven
Organization:
KU Leuven
Study Overview
Official Title:
Effectiveness of a Combined Food Literacy and Physical Activity Intervention to Optimize Metabolic Health Among Women of Reproductive Age in Urban Uganda
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Over the last 20 years metabolic health blood glucose and fats of Ugandans particularly residing in urban areas has increasingly become sub optimal Women are the most affected Sub optimal metabolic health increases chances of developing diseases known as non-communicable diseases NCD for example type 2 diabetes and heart diseases NCD are expensive to treat and Uganda lacks the health system to manage them Therefore there is need to prevent NCD Metabolic health is mainly linked to dietary and physical activity behaviour Studies show an increase in physical inactivity in urban Uganda especially among women Likewise what urban Ugandans eat deviates from healthy recommendations by World Health Organization For example 9 in 10 urban Ugandans do not meet the daily fruit and vegetable health recommendations Research shows that unhealthy eating and physical inactivity behaviours in urban Uganda are due to socio-cultural conceptions prestige linked to weight gain and consumption of animal protein and knowledgeskills gaps Following the intervention mapping protocol investigators have therefore designed an intervention to help women living in urban Uganda improve eating and physical activity behaviours to align them to healthy recommendations Investigators target women because they are the most vulnerable health wise possibility of passing on NCD risk from the mother to the offspring Women are as well the most strategic for family behavioural change as they oversee dietary decisions in homes The purpose of this study is to assess the effectiveness of a combined food literacy and physical activity intervention in optimizing metabolic health among women of reproductive age living in Urban Uganda The study is a cluster randomized control trail divided into two phases a three months intervention and a three months post-intervention follow-up phase Primary outcome is waist circumference The target group are women of reproductive age 18 to 45 years residing in Kampala Intervention will be delivered through religious women group structures
Detailed Description:
The study will be a cluster-randomized controlled trial The CONSORT recommendations for cluster randomized trials will be followed 29 The study period is divided into two phases a three months intervention and a three months post-intervention follow-up phase The intervention will be delivered through institutional religious women groups A collaboration has been established with Our Lady of Africa Parish Mbuya Mbuya Catholic Parish has six sub parishes These sub parishes will act as the clusters and will be the unit of randomization Within the sub parishes there are existing women groups These existing groups will be utilized for face to face intervention group sessions For the intervention purposes each group will be limited to a maximum of 14 members
Intervention
In the intervention arm participants will be exposed to the developed intervention materials booklet and face to face group sessions In the group session focus will be on increasing knowledge skills and self-efficacy to develop a lifelong healthy and gastronomic relationship with food and physical activity Specifically the intervention will focus on increasing womens ability to evaluate nutrition information consumption of fruits and vegetables and engagement in moderate physical activity Investigators will provide information skills training and feedback through monitoring The intervention consists of five interactive group sessions The group sessions will be two hours in length In summary the intervention will include
Profiling of personal gapsneeds based on the baseline measurements participants will be guided to compare their personal profiles physical activity and fruit and vegetable intake with WHO health recommendations
From this profiling participants will brainstorm barriers and solutions to gaps in personal profile compared to health recommendations
Participants will then be guided to identify opportunities within their environment to improve personal profile set personal SMART goals and to come up with action plans to attain the set goals
Periodic feedback sessions aimed at reviewing and adapting the goals will be given During feedback sessions role models participants who attain their goals will share their experiences challenges and enabling factors to motivate the other group members
Vegetable recipes practical tips to improve food literacy fruit and vegetable consumption and physical activity levels will be provided The sessions will be moderated by a research team led by a PhD student who is trained in motivational interviewing
Control arm
In the control arm participants will only be given the developed intervention materials Face to face group sessions will not be held for the control arm Therefore the research team will interface with the control groups at three moments baseline measurementsdistribution of developed intervention materials to the participants designed in form of the usual awareness programs post intervention measurements and post follow-up measurements
Intervention
In the intervention arm participants will be exposed to the developed intervention materials booklet and face to face group sessions In the group session focus will be on increasing knowledge skills and self-efficacy to develop a lifelong healthy and gastronomic relationship with food and physical activity Specifically the intervention will focus on increasing womens ability to evaluate nutrition information consumption of fruits and vegetables and engagement in moderate physical activity Investigators will provide information skills training and feedback through monitoring The intervention consists of five interactive group sessions The group sessions will be two hours in length In summary the intervention will include
Profiling of personal gapsneeds based on the baseline measurements participants will be guided to compare their personal profiles physical activity and fruit and vegetable intake with WHO health recommendations
From this profiling participants will brainstorm barriers and solutions to gaps in personal profile compared to health recommendations
Participants will then be guided to identify opportunities within their environment to improve personal profile set personal SMART goals and to come up with action plans to attain the set goals
Periodic feedback sessions aimed at reviewing and adapting the goals will be given During feedback sessions role models participants who attain their goals will share their experiences challenges and enabling factors to motivate the other group members
Vegetable recipes practical tips to improve food literacy fruit and vegetable consumption and physical activity levels will be provided The sessions will be moderated by a research team led by a PhD student who is trained in motivational interviewing
Control arm
In the control arm participants will only be given the developed intervention materials Face to face group sessions will not be held for the control arm Therefore the research team will interface with the control groups at three moments baseline measurementsdistribution of developed intervention materials to the participants designed in form of the usual awareness programs post intervention measurements and post follow-up measurements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None