Overweight and Obesity in Relation to Type ll Diabetes Melitus

NCT ID: NCT04016012

Last Updated: 2022-09-21

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-30

Study Completion Date

2023-10-15

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

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Local Zambian Foods

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type NO_INTERVENTION

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.

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zambia

OTHER

Sponsor Role collaborator

Afe Babalola University, Nigeria

UNKNOWN

Sponsor Role collaborator

Buea University, Cameroon

UNKNOWN

Sponsor Role collaborator

Sokoine University of Agriculture

OTHER

Sponsor Role collaborator

Kitwe Teaching Hospital, Zambia

UNKNOWN

Sponsor Role collaborator

National Science and Technology Council

FED

Sponsor Role collaborator

Mukuba University

OTHER

Sponsor Role lead

Responsible Party

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Given Chipili

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Zambia

Central Contacts

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Given Chipili

Role: CONTACT

+26097874900

Chiza Kumwenda

Role: CONTACT

+260974150967

Facility Contacts

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Given Chipili

Role: primary

+260978374900

Other Identifiers

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MU0619

Identifier Type: -

Identifier Source: org_study_id

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