Food Literacy and Physical Activity Intervention to Optimize Metabolic Health Among Women in Urban Uganda
Condition: Abdominal Obesity
MeSH terms: Obesity, Abdominal
Study type: Interventional

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.
    

Intervention name(s): Food literacy and physical activity promotion interactive group sessions + Developed health promotion intervention materials (booklet); Developed health promotion intervention materials (booklet).
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Information, skills training, goal setting and feedback interactive group sessions to improve food literacy aimed at increasing consumption of fruits and vegetables
Information, skills training, goal setting and feedback interactive group sessions to increase engagement in moderate physical activity
Information and skills training to increase ability to evaluate nutrition information
In general, focus will be on increasing knowledge, skills and self-efficacy to develop a lifelong healthy and gastronomic relationship with food and physical activity.; In the control arm, participants will only be given the developed intervention materials (designed in form of the usual awareness programs). No group sessions will be conducted
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Participant)
Primary purpose: Prevention