DDI-MWI-KA-MEIRU-NUT-2019-v01
NUT Development of nutritional strategies for diabetes prevention in Malawian adults at high diabetes risk Karonga
| Name | Country code |
|---|---|
| Malawi | MWI |
Diabetes prevalence in Malawi, at 5.5%, is comparable to high-income countries (HIC) in Europe, despite a relatively low prevalence of obesity and physical inactivity. Approximately 40% of Malawians with diabetes have 'normal' BMIs. We hypothesised that a combination of sub-optimal nutrition in utero and/or childhood and high levels of exposure to infection which together contribute to low muscle mass and strength are likely to contribute to a different diabetes risk phenotype in Malawians compared to those in HIC. Thus interventions, focused on weight loss and increased physical activity, which have been effective at preventing diabetes in HIC may not be effective in Malawi and a shift towards nutritional interventions focused on increasing muscle mass & strength and reducing inflammation was likely a more effective approach. Our long-term aim was therefore to develop and implement effective and pragmatic large-scale nutritional interventions optimized to prevent diabetes in Malawians at elevated diabetes risk. The overall aim of this project was to undertake key initial steps to facilitate the development of such interventions. Our first objective was to increase understanding of the links between nutritional intake and status, and the physical, metabolic and inflammatory phenotype in Malawian adults at increased risk of diabetes. To achieve this we recruited 50 participants (25 from rural and 25 from urban areas) with pre-diabetes and an equivalent number of age- and sex- matched healthy participants (25 rural and 25 urban) and make measurements of dietary intake, body composition, grip strength, physical activity levels, cardiometabolic risk profile (glucose, HbA1c, lipids, insulin, blood pressure), gut microbiota and inflammatory markers (detailed below). This enabled detailed characterization of the Malawian 'pre-diabetes' phenotype and identification of aspects of dietary intake which could potentially be altered in nutritional interventions to reduce diabetes risk. Our second aim was to explore nutritional practices and understandings of diabetes in urban and rural communities in Malawi, and consider which nutritional practices might be amenable to changes likely to reduce risk of developing diabetes. To achieve this we undertook secondary analysis of existing interview, focus group and observational qualitative data collected by MEIRU during studies investigating salt intake and diabetes medication adherence in Malawi [NHRSC protocol ~1425], and supplemented this with primary data collection (via focus groups) to explore nutritional and physical activity (exercise) practices and understandings of diabetes in urban and rural communities in Malawi, and considered which nutritional and physical activity practices might be amenable to changes likely to reduce risk of developing diabetes.
NHSRC number: 18/01/1951
Individual
2020-11-05
Malnutrition
Growth Disorders
Adolescent
Cognition
Cardiovascular Diseases
BodyComposition
Physical fitness
Sodium
Hypertension
Cardiovascular diseases
| Topic | Vocabulary |
|---|---|
| Malnutrition | MeSH |
| Growth Disorders | MeSH |
| Adolescent | MeSH |
| Cognition | MeSH |
| Cardiovascular Diseases | MeSH |
| Body Composition | MeSH |
| Physical fitness | MeSH |
| Malawi | MeSH |
| Sodium | |
| Hypertension | |
| Cardiovascular diseases |
Chilumba
| Name | Affiliation |
|---|---|
| Prof Mia Crampin | Malawi Epidemiology and Intervention Research Unit |
| Dr Christopher Bunn | University of Glasgow |
| Name | Affiliation | Role |
|---|---|---|
| McDonald Chabwera | Malawi Epidemiology and Intervention Research Unit | Study lead (Lilongwe) |
| Shekinah Mkandawire | Malawi Epidemiology and Intervention Research Unit | Study lead (Chilumba) |
| Hazel Namadingo | Malawi Epidemiology and Intervention Research Unit | Investigator |
| Dr Beatrice Mtimuni | Lilongwe University of Agriculture and Natural Resources | Investigator |
| Prof Victor Mwapasa | Investigator | |
| Prof Moffat Nyirenda | Investigator | |
| Prof Jason Gill | University of Glasgow | Investigator |
| Dr. Cindy Gray | University of Glasgow | Investigator |
| Dr Christine Edwards | University of Glasgow | Investigator |
| Name | Abbreviation | Role |
|---|---|---|
| Medical Research Council (UK) | MRC | Funder |
| University of Glasgow | UoG | Sponsor |
In this initial project, funded to promote development of nutritional research around NCD and develop partnerships, we had no prior data on expected prevalence of most of the outcome measures in pre-diabetic participants as this group was not studied in this setting before. We do have data on the prevalence of obesity in these groups from our baseline NCD survey. We expected other abnormal indices to have similar magnitudes of difference, but had no data available for sample size calculations at this stage. It was likely that this hypothesis generating study would generate good estimates of risk that can support sample size calculations for an intervention trial which was the long term goal.
Our study size was 50 pre-diabetics and 50 age-sex matched participants will have 93% power to detect the observed difference in obesity rates between the two groups (8% healthy, 35% pre-diabetic have BMI > 30kg/m2)):
alpha = 0.0500 (one-sided)
p1 = 0.0800
p2 = 0.3500
sample size n1 = 50
n2 = 50
n2/n1 = 1.00
Estimated power:
power = 0.9306
NUT study used a number of questionnaires including the following: Weighed food records which was used to determine the amount of food that was consumed by the participants. This questionnaire helped in the validation of a food frequency questionnaire (FFQ) which was the used for a similar purpose in the main study. The study also used a multi-pass food frequency questionnaire which works in a similar way as the food frequency questionnaire. Other questionnaires include Health history questionnaire which basically asks how active the participants were during the study period and the data from this questionnaire helps to check how healthy the participants were during the entire study period.
Blood pressure , Grip strength, Skinfold thickness and ECG were also used to check for cardiovascular health, strength of both hands, the amount of fat mass and body composition respectively.
All the questionnaires were formed in English and later translated into Chichewa and Tumbuka depending on the site of the study. Anthropometric measurements and stool samples were collected from all study participants to help the laboratory team check for gut micro biota that relates to consumption of food which may protect or predispose a person to diabetes.
| Start | End | Cycle |
|---|---|---|
| 2018-12-10 | 2019-03-19 | 1 |
| Name | Abbreviation |
|---|---|
| Malawi Epidemiology and Intervention Research Unit | MEIRU |
| Name |
|---|
| Malawi Epidemiology and Intervention Research Unit |
DDI-MWI-KA-MEIRU-NUT-2019-v01
| Name | Abbreviation | Affiliation | Role |
|---|---|---|---|
| Malawi Epidemiology and Intervention Research Unit | MEIRU | Agency | |
| Estelle McLean | EM | LSHTM and MEIRU | Production of the documentation used to create this DDI document. |
| Chifundo Kanjala | CK | MEIRU | Data documentalist |
| Dominic Nzundah | DN | MEIRU | Metadata entry and editing |
2020-11-05
version 1 (October, 2020)