Overweight and Obesity in Relation to Type ll Diabetes Melitus

Study Overview
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Brief Summary
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The aim of the study is to evaluate the efficacy of local Zambian food in improving metabolic profiles of overweight/obese type ll diabetic patients in Kitwe district

Official Title
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Overweight and Obesity in Relation to Type II Melitus,Diabetes A Randomised Controlled Trial

Conditions
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Diabetes Mellitus, Type 2, Overweight and Obesity

Intervention / Treatment
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* Dietary Supplement: Local Zambian Foods


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetic patients attending Kitwe Teaching Hospital 18 years and above Body Mass Index of 25 and above Willing to follow the diet plan and eat food provided Not enrolled in other clinical studies Exclusion Criteria: Eating disorder or any psychosocial or scheduling factors that could impede study outcomes Have renal or liver problem Pregnant women Breast feeding women HIV positive individuals

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The intervention group will receive a diabetic controlled diet using local Zambian foods for 8 weeks and standard health care for 8 weeks while the control group will eat their usual food in their home and receive standard health care for eight (8) weeks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Participants in the intervention group will receive local zambian foods and standard health care for eight (8) weeks. | Dietary Supplement: Local Zambian Foods<br>* Each week, participants in the intervention group will collect a pack of foodstuffs to last a week from the research site. The packs will be adjusted according to the weight of the participant and daily recommended allowances. Packaging of foodstuffs will be done in the food service lab at the Mukuba University. Instructions on how to prepare and use the food will be given to the participants. All food Items will be labelled diabetic food to avoid intra-household sharing.<br>|
| No Intervention: Control arm<br>The control group will have their usual (standard) diet in their home and receive standard health care for eight (8) weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Blood glucose levels | Fingertip blood sugar test using: blood glucose meter, test strips, lancet device, dry swabs, methylated spirit and a sharps box. | At baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body weight | Weight will be measured using the Seca adult scale | At baseline and 8 weeks | 
| Change of Body Mass Index (BMI) | Hand held BMI machine will be used to determine the BMI of each participant. | At baseline and 8 weeks |