NCT03423966

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

August 21, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2019

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

5 months

First QC Date

January 31, 2018

Last Update Submit

February 15, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

    Changes in weight after the use of pedometer app

    4 months

Secondary Outcomes (3)

  • Body Mass Index

    4 month

  • Waist Circumference

    4 Months

  • Blood Pressure

    4 months

Study Arms (2)

Self Objective Mobility Evaluation

EXPERIMENTAL

Usual Care Plus a Smartphone pedometer App

Device: Smartphone Pedometer App

Usual Care (UC)

NO INTERVENTION

Usual Care of obesity

Interventions

Installation of the free pedometer app and explanation to participants to target 10000 steps per day. The intent is not the accuracy of the pedometer but the motivation especially to a community yet to harness the full potentials of the mobile phone technology

Self Objective Mobility Evaluation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Hospital Abuja

Abuja, Federal Capital Territory, 00009, Nigeria

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ngong H Cyprian, MBBS

    National Hospital, Abuja

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Registrar and Secretary, Research and Academic Committee

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 6, 2018

Study Start

August 21, 2018

Primary Completion

January 21, 2019

Study Completion

January 30, 2019

Last Updated

February 18, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

I will not share the raw data

Locations