Overweight and Obesity in Relation to Type ll Diabetes Melitus
NCT ID: NCT04016012
Last Updated: 2022-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2023-04-30
2023-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention arm
Participants in the intervention group will receive local zambian foods and standard health care for eight (8) weeks.
Local Zambian Foods
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.
Control arm
The control group will have their usual (standard) diet in their home and receive standard health care for eight (8) weeks.
No interventions assigned to this group
Interventions
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Local Zambian Foods
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Have renal or liver problem
* Pregnant women
* Breast feeding women
* HIV positive individuals
18 Years
55 Years
ALL
Yes
Sponsors
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University of Zambia
OTHER
Afe Babalola University, Nigeria
UNKNOWN
Buea University, Cameroon
UNKNOWN
Sokoine University of Agriculture
OTHER
Kitwe Teaching Hospital, Zambia
UNKNOWN
National Science and Technology Council
FED
Mukuba University
OTHER
Responsible Party
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Given Chipili
Dr
Principal Investigators
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Given Chipili
Role: PRINCIPAL_INVESTIGATOR
Mukuba University, Kitwe, Zambia
Locations
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Kitwe Teaching Hospital
Kitwe, Copperbelt, Zambia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MU0619
Identifier Type: -
Identifier Source: org_study_id
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