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Overweight and Obesity in Relation to Type ll Diabetes Melitus

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04016012
Enrollment
90
Registered
2019-07-11
Start date
2023-04-30
Completion date
2023-10-15
Last updated
2022-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Overweight and Obesity

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

Interventions

DIETARY_SUPPLEMENTLocal 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.

Sponsors

University of Zambia
CollaboratorOTHER
Afe Babalola University, Nigeria
CollaboratorUNKNOWN
Buea University, Cameroon
CollaboratorUNKNOWN
Sokoine University of Agriculture
CollaboratorOTHER
Kitwe Teaching Hospital, Zambia
CollaboratorUNKNOWN
National Science and Technology Council
CollaboratorFED
Mukuba University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Blood glucose levelsAt baseline and 8 weeksFingertip blood sugar test using: blood glucose meter, test strips, lancet device, dry swabs, methylated spirit and a sharps box.

Secondary

MeasureTime frameDescription
Change in Body weightAt baseline and 8 weeksWeight will be measured using the Seca adult scale
Change of Body Mass Index (BMI)At baseline and 8 weeksHand held BMI machine will be used to determine the BMI of each participant.

Countries

Zambia

Contacts

Primary ContactGiven Chipili
chipiligiven@yahoo.com+26097874900
Backup ContactChiza Kumwenda
chiza.kumwenda@unza.zm+260974150967

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026