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

NCT04635332 | Completed

• 1 other identifier: HS974ES
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Fasting glucose,

  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)

  Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)

• Body composition

  Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)

• Blood pressure

  Measured at baseline, at post intervention (at 3 months) and at post follow-up (at 6 months)

• BMI

  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)

Other Outcomes (1)

• Process evaluation indicators (reach, dose and fidelity of intervention)

  Assessed throughout the 3 months intervention

Study Arms (2)

Intervention

EXPERIMENTAL

In the intervention arm, participants will be exposed to the developed intervention materials and face to face group sessions.

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.

Behavioral: Developed health promotion intervention materials (booklet).

Interventions

Food literacy and physical activity promotion interactive group sessions + Developed health promotion intervention materials (booklet) BEHAVIORAL

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

Developed health promotion intervention materials (booklet). BEHAVIORAL

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

Control arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• KU Leuven: lead
• VLIR-UOS: collaborator
• Kyambogo University: collaborator
• Our Lady of Africa Mbuya Catholic Parish: collaborator

Study Sites (1)

Peter Yiga

Kampala, Uganda

Location

Related Publications (8)

• 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.

  PMID: 32460934 BACKGROUND

• 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.

  PMID: 33000718 BACKGROUND

• 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.

  PMID: 32020062 BACKGROUND

• 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.

  PMID: 24462490 BACKGROUND

• 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.

  PMID: 28653598 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 36811566 DERIVED

• 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.

  PMID: 35183134 DERIVED

MeSH Terms

Conditions

Obesity, Abdominal

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Yiga

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Christophe Matthys

  KU Leuven

  STUDY CHAIR

• Patrick Ogwok

  Kyambogo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: In the sub parishes, women group leaders and participants will be blinded about the study arms.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD fellow

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 19, 2020
• Study Start: November 21, 2020
• Primary Completion: May 8, 2021
• Study Completion: May 8, 2021
• Last Updated: June 2, 2021

Record last verified: 2021-05

Locations

UG (1)