NCT04635332

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

Completed NA Last updated 2 June 2021

What this trial tests

NA trial testing Food literacy and physical activity promotion interactive group sessions + Developed health promotion intervention materials (booklet) in Abdominal Obesity in 132 participants. Completed in 8 May 2021.

Timeline

21 November 2020

Primary endpoint
8 May 2021

8 May 2021

Quick facts

Lead sponsor	KU Leuven
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	132
Start date	21 November 2020
Primary completion	8 May 2021
Estimated completion	8 May 2021
Sites	1 location across Uganda

Drugs / interventions tested

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

Conditions studied

• Abdominal Obesity — all drugs for Abdominal Obesity →

Sponsor

KU Leuven — full company profile →

Who can join

Adults 18 to 45, female only, with Abdominal Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of a complex lifestyle intervention to optimize metabolic health among females of reproductive age in urban Uganda, a randomized controlled trial.
   Yiga P, Van der Schueren B, Seghers J, Kiyimba T, et al · · 2023 · cited 2× · PMID 36811566 · DOI 10.1016/j.ajcnut.2022.12.005
2. The conceptual framework for a combined food literacy and physical activity intervention to optimize metabolic health among women of reproductive age in urban Uganda.
   Yiga P, Van Lippevelde W, Seghers J, Ogwok P, et al · · 2022 · cited 1× · PMID 35183134 · DOI 10.1186/s12889-022-12740-w