Food Literacy and Physical Activity Intervention to Optimize Metabolic Health Among Women in Urban Uganda

Abdominal Obesity Clinical Trial

Official title:

Effectiveness of a Combined Food Literacy and Physical Activity Intervention to Optimize Metabolic Health Among Women of Reproductive Age in Urban Uganda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04635332
• Other study ID #: HS974ES
• Status: Completed
• Phase: N/A
• Start date: November 21, 2020
• Est. completion date: May 8, 2021

Study information

• Verified date: May 2021
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: May 8, 2021
• Est. primary completion date: May 8, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Obesity
• Obesity, Abdominal

Intervention

Behavioral:
• 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.
• 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

Locations

Country	Name	City	State
Uganda	Peter Yiga	Kampala

Sponsors (4)

Lead Sponsor	Collaborator
KU Leuven	Kyambogo University, Our Lady of Africa Mbuya Catholic Parish, VLIR-UOS

Country where clinical trial is conducted

Uganda, 

References & Publications (6)

Azevedo Perry E, Thomas H, Samra HR, Edmonstone S, Davidson L, Faulkner A, Petermann L, Manafò 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. Review. — View Citation

Eldredge LKB, Markham CM, Ruiter RA et al. (2016) Planning health promotion programs: an intervention mapping approach: John Wiley & Sons.

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, Després 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. Review. — View 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. — View 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. 2020 Oct 1:1-13. doi: 10.1017/S1368980020003432. [Epub ahead of print] — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Process evaluation indicators (reach, dose and fidelity of intervention)	Adherence to the programme	Assessed throughout the 3 months intervention
Primary	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 at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Secondary	Fasting glucose,	CardioChek Plus will be used to assess the blood glucose	Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Secondary	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 at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Secondary	Body composition	Body composition will be measured using Bodystat 1500 lite touch	Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Secondary	Blood pressure	Blood pressure will be measured using blood pressure monitor - Seca b12	Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Secondary	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.	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)
Secondary	Food literacy and fruit and vegetable intake	Food literacy will be assessed using the Ugandan food literacy questionnaire	Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)
Secondary	Physical activity levels	Physical activity will be measured using the validated short form of the international physical activity questionnaire	Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)