Clinical trial NCT04635332: Food Literacy and Physical Activity Intervention to Optimize Metabolic Health Among Women in Urban Uganda
Official title: Effectiveness of a Combined Food Literacy and Physical Activity Intervention to Optimize Metabolic Health Among Women of Reproductive Age in Urban Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Obesity
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: VLIR-UOS
name: Kyambogo University
name: Our Lady of Africa Mbuya Catholic Parish
First posted: 2020-11-19
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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. The six sub parishes will be randomized to treatment and control arms. The six sub parishes (clusters) will be listed alphabetically. A cluster randomization with a 1:1 allocation will then be applied to randomize the sub parishes to either the treatment or control arm.
Primary purpose: PREVENTION

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 knowledge/skills 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; women's 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 gaps/needs; 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 measurements/distribution of developed intervention materials to the participants (designed in form of the usual awareness programs), post intervention measurements and post follow-up measurements.

Eligibility criteria: Inclusion Criteria:

1. Sex (women)
2. Age (18 to 45 years)
3. Diagnosed with central obesity \[waist circumference ≥ 80 cm\]
4. Willingness to follow the three-months intervention and three months follow-up.
5. Willingness to participate in the study and to sign the informed consent

Exclusion Criteria:

1. Participants diagnosed or being treated for diabetes Mellitus Type 1 or Type 2
2. Participants being treated for hypertension, high cholesterol or any other cardio-metabolic related disease.

Primary outcomes:
measure: Waist circumference
timeFrame: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Secondary outcomes:
measure: Fasting glucose,
timeFrame: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
measure: Lipid profile (total cholesterol, HDL cholesterol and triglycerides)
timeFrame: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
measure: Body composition
timeFrame: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
measure: Blood pressure
timeFrame: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
measure: BMI
timeFrame: Height will be measured at baseline while weight will be measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
measure: Food literacy and fruit and vegetable intake
timeFrame: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
measure: Physical activity levels
timeFrame: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Other outcomes:
measure: Process evaluation indicators (reach, dose and fidelity of intervention)
timeFrame: Assessed throughout the 3 months intervention
Locations:
city: Kampala
country: Uganda
facility: Peter Yiga
Study officials:
affiliation: KU Leuven
name: Peter Yiga
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Christophe Matthys
role: STUDY_CHAIR
affiliation: Kyambogo University
name: Patrick Ogwok
role: STUDY_CHAIR
References:
citation: Yiga P, Seghers J, Ogwok P, Matthys C. Determinants of dietary and physical activity behaviours among women of reproductive age in urban sub-Saharan Africa: a systematic review. Br J Nutr. 2020 Oct 28;124(8):761-772. doi: 10.1017/S0007114520001828. Epub 2020 May 28.
citation: Yiga P, Ogwok P, Achieng J, Auma MD, Seghers J, Matthys C. Determinants of dietary and physical activity behaviours among women of reproductive age in urban Uganda, a qualitative study. Public Health Nutr. 2021 Aug;24(12):3624-3636. doi: 10.1017/S1368980020003432. Epub 2020 Oct 1.
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citation: Yiga P, Van Lippevelde W, Seghers J, Ogwok P, Tafiire H, Muluuta SN, Matthys C. The conceptual framework for a combined food literacy and physical activity intervention to optimize metabolic health among women of reproductive age in urban Uganda. BMC Public Health. 2022 Feb 18;22(1):351. doi: 10.1186/s12889-022-12740-w.