Back to resultsOverweight and Obesity in Relation to Type ll Diabetes Melitus
Primary Purpose
Diabetes Mellitus, Type 2, Overweight and Obesity
Status
Not yet recruiting
Phase
Not Applicable
Locations
Zambia
Study Type
Interventional
Intervention
Local Zambian Foods
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
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
Sites / Locations
- Kitwe Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention arm
Control arm
Arm Description
Participants in the intervention group will receive local zambian foods and standard health care for eight (8) weeks.
The control group will have their usual (standard) diet in their home and receive standard health care for eight (8) weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Body weight
Weight will be measured using the Seca adult scale
Change of Body Mass Index (BMI)
Hand held BMI machine will be used to determine the BMI of each participant.
Full Information
NCT ID
NCT04016012
First Posted
July 7, 2019
Last Updated
September 16, 2022
Sponsor
Mukuba University
Collaborators
University of Zambia, Afe Babalola University, Nigeria, Buea University, Cameroon, Sokoine University of Agriculture, Kitwe Teaching Hospital, Zambia, National Science and Technology Council
1. Study Identification
Unique Protocol Identification Number
NCT04016012
Brief Title
Overweight and Obesity in Relation to Type ll Diabetes Melitus
Official Title
Overweight and Obesity in Relation to Type II Melitus,Diabetes A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 30, 2023 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mukuba University
Collaborators
University of Zambia, Afe Babalola University, Nigeria, Buea University, Cameroon, Sokoine University of Agriculture, Kitwe Teaching Hospital, Zambia, National Science and Technology Council
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Overweight and Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Participants in the intervention group will receive local zambian foods and standard health care for eight (8) weeks.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
The control group will have their usual (standard) diet in their home and receive standard health care for eight (8) weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Local Zambian Foods
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Blood glucose levels
Description
Fingertip blood sugar test using: blood glucose meter, test strips, lancet device, dry swabs, methylated spirit and a sharps box.
Time Frame
At baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change in Body weight
Description
Weight will be measured using the Seca adult scale
Time Frame
At baseline and 8 weeks
Title
Change of Body Mass Index (BMI)
Description
Hand held BMI machine will be used to determine the BMI of each participant.
Time Frame
At baseline and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Given Chipili
Phone
+26097874900
Email
chipiligiven@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chiza Kumwenda
Phone
+260974150967
Email
chiza.kumwenda@unza.zm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Given Chipili
Organizational Affiliation
Mukuba University, Kitwe, Zambia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kitwe Teaching Hospital
City
Kitwe
State/Province
Copperbelt
ZIP/Postal Code
50100
Country
Zambia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Given Chipili
Phone
+260978374900
Email
chipiligiven@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data collected in this study will be published online
IPD Sharing Time Frame
6 months after the study ends.
IPD Sharing Access Criteria
Mukuba University Website
IPD Sharing URL
http://www.mukuba.edu.zm
Learn more about this trial
Overweight and Obesity in Relation to Type ll Diabetes Melitus
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