MannaPack™ Potato Clinical Trial

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MannaPack™ Potato Clinical Trial Wilna Oldewage-Theron PhD RD (SA) & Abdulkadir Egal PhD (PH)

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MannaPack™ Potato Clinical Trial. Wilna Oldewage-Theron PhD RD (SA) & Abdulkadir Egal PhD (PH) ‏. OUTLINE OF PRESENTATION. Introduction Background Stakeholders Methods Results Limitations Conclusions Recommendations. BACKGROUND: South Africa. 49.32 million (SSA 2009) ‏ - PowerPoint PPT Presentation

Transcript of MannaPack™ Potato Clinical Trial

MannaPack™ Potato Clinical Trial

Wilna Oldewage-TheronPhD RD (SA) &

Abdulkadir Egal PhD (PH)

OUTLINE OF PRESENTATION

• Introduction

• Background

• Stakeholders

• Methods

• Results

• Limitations

• Conclusions

• Recommendations

BACKGROUND: South Africa• 49.32 million (SSA 2009)

• 40% live in poverty (Cunnan & Maharaj, 2000:669, SA Govt, 2001)

• 2.5% hungry (1.23 million people household food insecurity) (SSA 2009)

• 20% of SA children stunted

• 33.3% iron deficiency anaemia in children and women

• 45.3% children at risk of zinc deficiency

• 10% of children overweight (Labadarios et al., 2008)

• 16.6% HIV and AIDS prevalence (WHO Stats, 2008)

INTRODUCTION• Diarrhea = one of the top killers of

children around the world

• Solution = medication or oral rehydration fluids

INTRODUCTION• FMSC - new product, MannaPack™ Potato

(MPP) to provide a “first food” in response to diarrhea

Dehydrated potato granules (resistant starches) Lecithinated soy flour (protein source) Gum arabic (soluble fiber) Vitamins and minerals Mild sweet potato flavoring

• Reduce the impact of diarrhea and maintain

the gut during diarrhea and recovery.

MannaPack™

MAIN AIM

Overall purpose of the project was to

document the actual impact and

acceptability of MannaPack™ to

reduce the impact and support resolution

of the symptom of chronic and acute diarrhea.

SPECIFIC OBJECTIVES

Assess the acceptability of

MannaPack™ in a setting that provides care and treatment for children with diarrhea.

Assess the impact of MannaPack™ on

the quality and quantity of acute and chronic diarrhea in a community setting.

STAKEHOLDERS

PROJECT METHODS

1. Planning• Ethics approval (M080365) • Strategic participatory planning workshop with

all stakeholders in South Africa (SA)• Two crèches in the Vaal region identified (control

group)• SOS village for HIV/AIDS-affected orphans in

Qwa-Qwa (experimental group). • Consent• Training of data enumerators and monitors

PROJECT METHODS

2. Measurements• Diarrhea questionnaire - baseline + 6 weekly• Sensory questionnaire – baseline and end

PROJECT METHODS

2. Measurements• Weight and height, handgrip, skin tenting

& nail blanching – baseline + 6 weeks

PROJECT METHODS

3. Intervention

QWA-QWA BACKGROUND

• 5 people per household (hh)• 89.9% of caregivers unemployed• 67.4% of partners unemployed• 59.1% of hh < R 1000 (US$133) pm• 51.0% hh food insecurity

• 4.9 people per hh• 94.1% of caregivers

unemployed• 80.1% of partners

unemployed• 58.3% of hh < US$133

pm• 53.0% hh food insecurity

VAAL REGION BACKGROUND

LIMITATIONS• Questionnaires not tested for SA but for

Zimbabwe only although in the same region

• Diarrhea not a public health problem in

SA – small sample size

• 2010 World Cup

Beneficiary profilewho completed the study

Children between the ages 2 to 13 years of age

• Experimental group consisted of 29 girls and 32 boys with overall mean age of 6.2 years

Control group was 27 girls and 22 boys with overall mean age of 3.5 years

• 2010 World Cup

RESULTSVariable Experimental group (n=63) Control group (n=49)

Baseline Follow-up Significance of change between

baseline and follow-up

(p)

Baseline Follow-up Significance of change between

baseline and follow-up

(p)

Age 6.2±3.6 6.4±3.5 3.4±1.2 3.4±1.1Weight (kg) 21.9±8.8 22.2±9.1 0.002 15.07±2.54 15.06±2.56 0.444

Height (m) 1.14±0.21 1.15±0.21 0.047 1.04±0.27 1.05±0.27 0.083

Skin tenting (seconds)

1.0±0.0 1.0±0.0 0.145 3.0±0.6 3.2±0.6 0.133

Nail blanching (seconds)

3.9±0.9 3.6±0.7 0.004 3.1±0.6 3.1±0.6 1.000

Handgrip right hand

7.5±4.2 7.4±4.1 0.400 - -

Handgrip left hand 7.0±4.4 7.1±4.2 0.681 - -

RESULTS: STUNTING (EXPERIMENTAL)

Classification Girlsn= (%)

Boysn= (%)

Total groupn=61 (%)

Baseline

Severely stunted

3.4 6.3 4.9

≥-3<-2 SD Stunted 10.3 6.3 8.2

Girlsn=25 (%)

Boysn=21 (%)

Total groupn=46 (%)

At the end of the intervention (Follow-up)

<-3 SD Severely stunted

3.4 6.3 4.9

≥-3<-2 SD Stunted 10.3 6.3 8.2

RESULTS: STUNTING (CONTROL)

Classification Girlsn=27 (%)

Boysn=22 (%)

Total groupn=49 (%)

Baseline

<-3 SD Severely stunted

0 5.9 2.3

≥-3<-2 SD Stunted 11.5 17.6 14.0

Girlsn=25 (%)

Boysn=21 (%)

Total groupn=46 (%)

At the end of the intervention (Follow-up)

<-3 SD Severely stunted

0 5.9 2.3

≥-3<-2 SD Stunted 11.5 17.6 14.0

RESULTS: UNDERWEIGHT (EXPERIMENTAL)

Classification Girlsn=25 (%)

Boysn=23 (%)

Total groupn=48 (%)

Baseline

<-3 SD Severely underweight

0 4.5 2.1

≥-3<-2 SD Underweight 11.5 4.5 8.3

Girlsn=25 (%)

Boysn=21 (%)

Total groupn=46 (%)

At the end of the intervention (Follow-up)

<-3 SD Severely underweight

0 0 0

≥-3<-2 SD Underweight 7.7 0 4.2

RESULTS: UNDERWEIGHT (CONTROL)

Classification Girlsn=25 (%)

Boysn=23 (%)

Total groupn=48 (%)

Baseline

<-3 SD Severely underweight

3.7 0 2.0

≥-3<-2 SD Underweight 3.7 4.5 4.1

Girlsn=25 (%)

Boysn=21 (%)

Total groupn=46 (%)

At the end of the intervention (Follow-up)

<-3 SD Severely underweight

3.7 0 2.0

≥-3<-2 SD Underweight 3.7 4.5 4.1

DIARRHEA INCIDENCE RESULTS

DIARRHEA RESULTS: NR OF STOOLS PER DAY

PRODUCT ACCEPTABILITY RESULTS: APPEARANCE

PRODUCT ACCEPTABILITY RESULTS: TEXTURE

PRODUCT ACCEPTABILITY RESULTS: TASTE

CONCLUSIONS• MannaPackT consumption results

indicated a minority consuming the product for the whole week.

• A significant improvement was observed for underweight after the intervention.

• Impact of the MannaPackTM on the nutritional status of the experimental group very clear.

• This was not observed in the control group.

CONCLUSIONS

• Incidence and severity of diarrhea significantly reduced in the experimental group as the study progressed.

• Control group remained largely

unchanged.

• MannaPackTM contributed to the

reduced incidence and prevalence of diarrhea in the experimental group.

ACCEPTABILITY RESULTS

• Mashed potatoes not commonly consumed by the low-income groups in South Africa.

• MannaPackTM not very acceptable at baseline.

• Liked the MannaPackTM towards the end of the study.

RECOMMENDATIONS

• MannaPackTM can be effectively used as a relief food in emergency situations where both diarrhea and/or acute food shortage exist.

• Can complement the already successful commodities like CSB and WSB in the USAID title II programmes.

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