Food Literacy and Physical Activity Intervention to Optimize Metabolic Health Among Women in Urban Uganda
Primary Purpose
Abdominal Obesity
Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Food literacy and physical activity promotion interactive group sessions + Developed health promotion intervention materials (booklet)
Developed health promotion intervention materials (booklet).
Sponsored by
About this trial
This is an interventional prevention trial for Abdominal Obesity
Eligibility Criteria
Inclusion Criteria:
- Sex (women)
- Age (18 to 45 years)
- Diagnosed with central obesity [waist circumference ≥ 80 cm]
- Willingness to follow the three-months intervention and three months follow-up.
- Willingness to participate in the study and to sign the informed consent
Exclusion Criteria:
- Participants diagnosed or being treated for diabetes Mellitus Type 1 or Type 2
- Participants being treated for hypertension, high cholesterol or any other cardio-metabolic related disease.
Sites / Locations
- Peter Yiga
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control arm
Arm Description
In the intervention arm, participants will be exposed to the developed intervention materials and face to face group sessions.
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.
Outcomes
Primary Outcome Measures
Waist circumference
Decreases in waist circumference are recommended as critically important treatment target for reducing adverse cardiometabolic health risks. Independent of sex and age, lifestyle induced reductions in waist circumference are associated with improvements in cardiometabolic risk factors with or without corresponding weight loss. Clinically relevant reductions in waist circumference can be achieved by routine, moderate- intensity exercise and/or dietary interventions consistent with WHO health recommendations. Thus, for the assessment of the effectiveness of lifestyle changes in adults, waist circumference is recommended. Waist circumference (to the nearest 0.5 cm) will be measured using a non-stretchable standard tape measure
Secondary Outcome Measures
Fasting glucose,
CardioChek Plus will be used to assess the blood glucose
Lipid profile (total cholesterol, HDL cholesterol and triglycerides)
CardioChek Plus will be used to assess the lipid profile (total cholesterol, HDL, LDL and triglycerides).
Body composition
Body composition will be measured using Bodystat 1500 lite touch
Blood pressure
Blood pressure will be measured using blood pressure monitor - Seca b12
BMI
Height will be taken to the nearest 0.1 cm using a Seca digital height board. Weight will be measured to the nearest 0.1 kg using the Seca 874 dr.
Food literacy and fruit and vegetable intake
Food literacy will be assessed using the Ugandan food literacy questionnaire
Physical activity levels
Physical activity will be measured using the validated short form of the international physical activity questionnaire
Full Information
NCT ID
NCT04635332
First Posted
November 13, 2020
Last Updated
May 31, 2021
Sponsor
KU Leuven
Collaborators
VLIR-UOS, Kyambogo University, Our Lady of Africa Mbuya Catholic Parish
1. Study Identification
Unique Protocol Identification Number
NCT04635332
Brief Title
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
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 21, 2020 (Actual)
Primary Completion Date
May 8, 2021 (Actual)
Study Completion Date
May 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
Collaborators
VLIR-UOS, Kyambogo University, Our Lady of Africa Mbuya Catholic Parish
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
In the sub parishes, women group leaders and participants will be blinded about the study arms.
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
In the intervention arm, participants will be exposed to the developed intervention materials and face to face group sessions.
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Food literacy and physical activity promotion interactive group sessions + Developed health promotion intervention materials (booklet)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Developed health promotion intervention materials (booklet).
Intervention Description
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
Primary Outcome Measure Information:
Title
Waist circumference
Description
Decreases in waist circumference are recommended as critically important treatment target for reducing adverse cardiometabolic health risks. Independent of sex and age, lifestyle induced reductions in waist circumference are associated with improvements in cardiometabolic risk factors with or without corresponding weight loss. Clinically relevant reductions in waist circumference can be achieved by routine, moderate- intensity exercise and/or dietary interventions consistent with WHO health recommendations. Thus, for the assessment of the effectiveness of lifestyle changes in adults, waist circumference is recommended. Waist circumference (to the nearest 0.5 cm) will be measured using a non-stretchable standard tape measure
Time Frame
Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Secondary Outcome Measure Information:
Title
Fasting glucose,
Description
CardioChek Plus will be used to assess the blood glucose
Time Frame
Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Title
Lipid profile (total cholesterol, HDL cholesterol and triglycerides)
Description
CardioChek Plus will be used to assess the lipid profile (total cholesterol, HDL, LDL and triglycerides).
Time Frame
Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Title
Body composition
Description
Body composition will be measured using Bodystat 1500 lite touch
Time Frame
Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Title
Blood pressure
Description
Blood pressure will be measured using blood pressure monitor - Seca b12
Time Frame
Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Title
BMI
Description
Height will be taken to the nearest 0.1 cm using a Seca digital height board. Weight will be measured to the nearest 0.1 kg using the Seca 874 dr.
Time Frame
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)
Title
Food literacy and fruit and vegetable intake
Description
Food literacy will be assessed using the Ugandan food literacy questionnaire
Time Frame
Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Title
Physical activity levels
Description
Physical activity will be measured using the validated short form of the international physical activity questionnaire
Time Frame
Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Other Pre-specified Outcome Measures:
Title
Process evaluation indicators (reach, dose and fidelity of intervention)
Description
Adherence to the programme
Time Frame
Assessed throughout the 3 months intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sex (women)
Age (18 to 45 years)
Diagnosed with central obesity [waist circumference ≥ 80 cm]
Willingness to follow the three-months intervention and three months follow-up.
Willingness to participate in the study and to sign the informed consent
Exclusion Criteria:
Participants diagnosed or being treated for diabetes Mellitus Type 1 or Type 2
Participants being treated for hypertension, high cholesterol or any other cardio-metabolic related disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Yiga
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christophe Matthys
Organizational Affiliation
KU Leuven
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Patrick Ogwok
Organizational Affiliation
Kyambogo University
Official's Role
Study Chair
Facility Information:
Facility Name
Peter Yiga
City
Kampala
Country
Uganda
12. IPD Sharing Statement
Citations:
PubMed Identifier
32460934
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.
Results Reference
background
PubMed Identifier
33000718
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.
Results Reference
background
PubMed Identifier
32020062
Citation
Ross R, Neeland IJ, Yamashita S, Shai I, Seidell J, Magni P, Santos RD, Arsenault B, Cuevas A, Hu FB, Griffin BA, Zambon A, Barter P, Fruchart JC, Eckel RH, Matsuzawa Y, Despres JP. Waist circumference as a vital sign in clinical practice: a Consensus Statement from the IAS and ICCR Working Group on Visceral Obesity. Nat Rev Endocrinol. 2020 Mar;16(3):177-189. doi: 10.1038/s41574-019-0310-7. Epub 2020 Feb 4.
Results Reference
background
PubMed Identifier
24462490
Citation
Vidgen HA, Gallegos D. Defining food literacy and its components. Appetite. 2014 May;76:50-9. doi: 10.1016/j.appet.2014.01.010. Epub 2014 Jan 22.
Results Reference
background
PubMed Identifier
28653598
Citation
Azevedo Perry E, Thomas H, Samra HR, Edmonstone S, Davidson L, Faulkner A, Petermann L, Manafo E, Kirkpatrick SI. Identifying attributes of food literacy: a scoping review. Public Health Nutr. 2017 Sep;20(13):2406-2415. doi: 10.1017/S1368980017001276. Epub 2017 Jun 27.
Results Reference
background
Citation
Eldredge LKB, Markham CM, Ruiter RA et al. (2016) Planning health promotion programs: an intervention mapping approach: John Wiley & Sons.
Results Reference
background
PubMed Identifier
35183134
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.
Results Reference
derived
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Food Literacy and Physical Activity Intervention to Optimize Metabolic Health Among Women in Urban Uganda
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