Abdominal ObesityNCT04635332
Food Literacy and Physical Activity Intervention to Optimize Metabolic Health Among Women in Urban Uganda
A study testing Food literacy and physical activity promotion interactive group sessions + Developed health promotion intervention materials (booklet) and Developed health promotion intervention materials (booklet). in people with Abdominal Obesity, run by KU Leuven at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Abdominal Obesity
- What is being tested?
- Food literacy and physical activity promotion interactive group sessions + Developed health promotion intervention materials (booklet) and Developed health promotion intervention materials (booklet).
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUganda
- Study dates
- 21 Nov 2020to 8 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Combined Food Literacy and Physical Activity Intervention to Optimize Metabolic Health Among Women of Reproductive Age in Urban Uganda
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.
Read the 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.
- Conditions
- Abdominal Obesity
- Being tested
- Food literacy and physical activity promotion interactive group sessions + Developed health promotion intervention materials (booklet), Developed health promotion intervention materials (booklet).
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food literacy and physical activity promotion interactive group sessions + Developed health promotion intervention materials (booklet)Behavioural
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.
Developed health promotion intervention materials (booklet).Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In the intervention arm, participants will be exposed to the developed intervention materials and face to face group sessions. Receives: Behavioral: Food literacy and physical activity promotion interactive group sessions + Developed health promotion intervention materials (booklet) |
| Control arm | Active comparator | 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. Receives: Behavioral: Developed health promotion intervention materials (booklet). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Secondary outcomes (7)
Fasting glucose,
CardioChek Plus will be used to assess the blood glucose
Measured: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Lipid profile (total cholesterol, HDL cholesterol and triglycerides)
CardioChek Plus will be used to assess the lipid profile (total cholesterol, HDL, LDL and triglycerides).
Measured: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Body composition
Body composition will be measured using Bodystat 1500 lite touch
Measured: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Blood pressure
Blood pressure will be measured using blood pressure monitor - Seca b12
Measured: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
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.
Measured: 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)
Food literacy and fruit and vegetable intake
Food literacy will be assessed using the Ugandan food literacy questionnaire
Measured: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Physical activity levels
Physical activity will be measured using the validated short form of the international physical activity questionnaire
Measured: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start21 Nov 2020
- Primary completion8 May 2021
- Study completion8 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Abdominal ObesityStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- VLIR-UOS, Kyambogo University, Our Lady of Africa Mbuya Catholic Parish
- Responsible party
- Principal investigator, Peter Yiga, KU Leuven
- Investigators
- Peter Yiga, Principal investigator, KU LeuvenChristophe Matthys, Study chair, KU LeuvenPatrick Ogwok, Study chair, Kyambogo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635332
- Sponsor's protocol ID
- HS974ES
- Status last verified
- May 2021
- First submitted
- 13 Nov 2020
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32460934Yiga 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.
PubMed 33000718Ross 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.
PubMed 32020062Vidgen 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.
PubMed 24462490Azevedo 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.
PubMed 28653598Eldredge LKB, Markham CM, Ruiter RA et al. (2016) Planning health promotion programs: an intervention mapping approach: John Wiley & Sons.
Yiga P, Van der Schueren B, Seghers J, Kiyimba T, Ogwok P, Tafiire H, Muluta SN, Matthys C. Effect of a complex lifestyle intervention to optimize metabolic health among females of reproductive age in urban Uganda, a randomized controlled trial. Am J Clin Nutr. 2023 Feb;117(2):436-443. doi: 10.1016/j.ajcnut.2022.12.005. Epub 2022 Dec 23.
PubMed 36811566Yiga 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.
PubMed 35183134
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Combined Food Literacy and Physical Activity Intervention to Optimize Metabolic Health Among Women of Reproductive Age in Urban Uganda
- ClinicalTrials.gov ID
- NCT04635332
- Acronym / sponsor ID
- HS974ES
- Conditions
- Abdominal Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- VLIR-UOS, Kyambogo University, Our Lady of Africa Mbuya Catholic Parish
- Study start
- 21 Nov 2020 (actual)
- Primary completion
- 8 May 2021 (actual)
- Study completion
- 8 May 2021 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Food literacy and physical activity promotion interactive group sessions + Developed health promotion intervention materials (booklet)In the intervention arm, participants will be exposed to the developed intervention materials and face to face group sessions. |
| Control arm | Active comparator | Behavioral: Developed health promotion intervention materials (booklet).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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food literacy and physical activity promotion interactive group sessions + Developed health promotion intervention materials (booklet)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. | Behavioural | Intervention |
| Developed health promotion intervention materials (booklet).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 | Behavioural | Control arm |
Primary outcome
Waist circumference
Time frame: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
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
7 secondary outcomes
Fasting glucose,
Time frame: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Lipid profile (total cholesterol, HDL cholesterol and triglycerides)
Time frame: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Body composition
Time frame: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Blood pressure
Time frame: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
BMI
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)
Food literacy and fruit and vegetable intake
Time frame: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Physical activity levels
Time frame: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Background: PubMed 32460934Yiga 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.
- Background: PubMed 33000718Yiga 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.
- Background: PubMed 32020062Ross 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.
- Background: PubMed 24462490Vidgen 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.
- Background: PubMed 28653598Azevedo 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.
- BackgroundEldredge LKB, Markham CM, Ruiter RA et al. (2016) Planning health promotion programs: an intervention mapping approach: John Wiley & Sons.
- Derived from this study: PubMed 36811566Yiga P, Van der Schueren B, Seghers J, Kiyimba T, Ogwok P, Tafiire H, Muluta SN, Matthys C. Effect of a complex lifestyle intervention to optimize metabolic health among females of reproductive age in urban Uganda, a randomized controlled trial. Am J Clin Nutr. 2023 Feb;117(2):436-443. doi: 10.1016/j.ajcnut.2022.12.005. Epub 2022 Dec 23.
- Derived from this study: PubMed 35183134Yiga 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Yiga principal investigator
KU Leuven
Christophe Matthys study chair
KU Leuven
Patrick Ogwok study chair
Kyambogo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food literacy and physical activity promotion interactive group sessions + Developed health promotion intervention materials (booklet) and Developed health promotion intervention materials (booklet). in people with Abdominal Obesity, run by KU Leuven at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waist circumference (time frame: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04635332, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.