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Clinical Trials/NCT03423966
NCT03423966CompletedNot Applicable

Effect of the Use of Smartphone Pedometers on the Weight of Overweight and Obese Clients at the General Outpatient Department, National Hospital Abuja.

National Hospital, Abuja2 sites in 1 country194 target enrollmentStarted: August 21, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
194
Locations
2
Primary Endpoint
Weight Loss

Study Overview

Brief Summary

The study sets out to determine the effect of smartphone pedometers on the body mass of overweight and obese clients at the general outpatient department, national hospital Abuja.

It is a synopsis of the proposed dissertation submitted to the West African College of Physicians in partial fulfillment of the requirements for the part 11 Fellowship examination of the faculty of Family Medicine.

Detailed Description

3.1 Study Area The Hospital is a melting pot of referral cases, fresh cases, executive patients and the masses alike and therefore gives a scout picture of the non-communicable diseases situation in Nigeria. First contact to undifferentiated patients is offered in the clinic. It is accredited by both the West African College of Physician and the National Postgraduate Medical College of Nigeria for residency training in Family Medicine.

3.2 Study Population The study will be carried out among consenting adult overweight and obese patients attending the GOPC of National Hospital Abuja.

3.3 Study Design This study is a Randomized Controlled Trial with parallel open label design.

3.4 Duration of Study The study will be conducted over a period of 24 weeks with a lead in period of 4 weeks for recruitment.

3.5 Minimum Sample Size Estimation The minimum sample size was calculated using the formula for sample size estimation for tests between two independent means.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Consenting screened participants that are overweight or obese who want to lose at least 5% of their baseline weight.
  • Adults aged 18 to 65 years old.

Exclusion Criteria

  • Clients on weight lose drugs because this may confound the cause of the weight loss.
  • Patients with conditions that do not allow mobility.
  • Patients with major organ failure because such patients may not be so stable to cope with prescribed exercise schedule.
  • Pregnancy; present, intending and 6 months postpartum because the cause of the weight loss or gain may be attributed to the pregnancy.
  • Morbidly obese clients because this are candidates for drug therapy and surgical interventions and it will be unethical to delay such interventions.
  • Clients with no android smartphone that are randomized to the intervention group because the intervention will not be possible.

Outcomes

Primary Outcomes

Weight Loss

Time Frame: 4 months

Changes in weight after the use of pedometer app

Secondary Outcomes

  • Body Mass Index(4 month)
  • Waist Circumference(4 Months)
  • Blood Pressure(4 months)

Investigators

Sponsor
National Hospital, Abuja
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Ngong Hipoletus Cyprian

Senior Registrar and Secretary, Research and Academic Committee

National Hospital, Abuja

Study Sites (2)

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