- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04635332
Food Literacy and Physical Activity Intervention to Optimize Metabolic Health Among Women in Urban Uganda
Effectiveness of a Combined Food Literacy and Physical Activity Intervention to Optimize Metabolic Health Among Women of Reproductive Age in Urban Uganda
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kampala, Uganda
- Peter Yiga
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention
In the intervention arm, participants will be exposed to the developed intervention materials and face to face group sessions.
|
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. |
ACTIVE_COMPARATOR: 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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting glucose,
Time Frame: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
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CardioChek Plus will be used to assess the blood glucose
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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)
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CardioChek Plus will be used to assess the lipid profile (total cholesterol, HDL, LDL and triglycerides).
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Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
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Body composition
Time Frame: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
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Body composition will be measured using Bodystat 1500 lite touch
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Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
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Blood pressure
Time Frame: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
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Blood pressure will be measured using blood pressure monitor - Seca b12
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Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
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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)
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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.
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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)
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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)
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Food literacy will be assessed using the Ugandan food literacy questionnaire
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Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
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Physical activity levels
Time Frame: Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
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Physical activity will be measured using the validated short form of the international physical activity questionnaire
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Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Process evaluation indicators (reach, dose and fidelity of intervention)
Time Frame: Assessed throughout the 3 months intervention
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Adherence to the programme
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Assessed throughout the 3 months intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peter Yiga, KU Leuven
- Study Chair: Christophe Matthys, KU Leuven
- Study Chair: Patrick Ogwok, Kyambogo University
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- Eldredge LKB, Markham CM, Ruiter RA et al. (2016) Planning health promotion programs: an intervention mapping approach: John Wiley & Sons.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS974ES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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