Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03423966 |
| Other study ID # |
NHA/EC/088/2017 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 21, 2018 |
| Est. completion date |
January 30, 2019 |
Study information
| Verified date |
February 2019 |
| Source |
National Hospital, Abuja |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
N = 2 s 2 (zcrit+ zpower)2 D2 Where N = Sample size estimate zcrit = critical value for alpha
(0.05 alpha has a zcrit of 1.960 zpower = value for 1-beta (80% power has a z of 0.842) s =
standard deviation D = the expected difference between the two means (i.e. the minimum
difference between the two means that will be considered clinically significant).
From a previous study that considered weight loss as the primary outcome in black women, the
standard deviation was 3.479 A difference in means of 1.44 kg is regarded as clinically
significant. Therefore, the sample size calculated for the weight variable in each arm of the
investigation will be; N = 2×3.42 (1.960+ 0.842)2/ 1.44 squared = 87.5 for each arm of the
study and a total of 176 participants.
The minimum sample size for the study is therefore 176. Being a medium term duration study,
we assume a maximum attrition rate of 10%, the final sample size to recruit is 194, with 97
participants in each arm of the study.
3.7 Study Instruments and Tools The data capture form broadly consists of 6 sections and
incorporates the fundamental aspects of an obesity consultation clinic; Android phone
versions higher than 3.0 with a Pedometer app version 5.19 by tayutau which is a simple easy
to use pedometer application that measures steps for physical activity monitoring. It has
three modes that count the steps, the distance or the calories burnt. It has the advantage of
recording at least 2 months of daily step counts and can be evaluated at leisure in the
clinic. It also shows your average pace.
Stadiometer: (By SECA; Vogel and Halke; made in Germany) will be used for height measurements
(cm).
Weighing Scale: (By SECA; Vogel and Halke; Made in Germany) will be used for weight
measurements (kg).
Sphygmomanometer: (Dekamet Accoson Mercury Sphygmomanometer, Made in England). Calibrated in
mmHg from 0 - 300 mmHg; arm cuff size 22 - 32(cm); will be used for blood pressure
measurements (mmHg).
Tape rule measure: Flexible, non-stretchable tape measure (NEWEY, Made in Germany).
Calibrated in (cm), from 0 - 150, will be used for WC measurements.
3.8 Study Procedure 3.81 Research Assistants Four research assistants will be trained in the
research proceedings including the initial screening, inclusion and exclusion criteria. The
research assistants are also resident doctors who have basic experience in the management of
obese clients.
3.82 Screening for Eligibility Screening for eligibility will be conducted at the first visit
in the General Outpatient Clinic by 4 trained research assistants. The age of the prospective
participant, ownership of a pedometer capable phone, the Body Mass Index and a pass in the
Physical Activity Readiness Questionnaire (PARQ) will be the minimum to proceed to the
randomization and study clinic.
A "Yes" response to any question in the PARQ requires further evaluation and depending on
severity, may render a participant ineligible for participation.
3.83 Randomization and Allocation Concealment At the study clinic, eligible consenting
participants will be randomized to the two arms of the study. Allocation concealment will be
achieved by using opaque envelopes containing allocation color coded cards, white for 'UC'
and pink for 'SOME' will be used to execute random assignment to the two group. Under
supervision of a research assistant, participants will pick one of the envelopes before
proceeding to the consulting room without opening the envelope for enrollment. Allocation
ratio will be 1:1.
Randomization will be achieved by having prospective participants pick color coded cards
before anthropometric examinations. After every pick, the envelopes will be reshuffled before
the next pick. The color coded cards will be stuck on the front inner cover of folders of all
participants to avoid confusion. They will be no formal blinding.
3.84 Aspects Common to Both Study Arms After signing the consent form, all eligible
participants will fill out a brief health-screening and qualification questionnaire within
the data capture form. Participants will all have the International Physical Activity
Questionnaire Short Form (IPAQ-SF) tools computed at the beginning to assess the level of
physical activity, at 8 weeks and at the end of the study (16 weeks) with results computed
into a continuous variable by the formula; Total MET/Min/week = [Walking METs × min × days] +
[Moderate METs × min × days] + [Vigorous METs × min × days] and finally grouped into
categorical variables of low, moderate and high physical activity levels.
Participants will be counseled using the 5A model and given an exercise prescription to
maintain for the duration of the study. They will be counseled on dietary modifications and
exercise plans. Basic lifestyle counseling will be in the form of a uniform lifestyle "SERVE"
advice slip modified from the one used by the Montefiore Medical Center, Albert Einstein
College of Medicine and New York University School of Medicine as reported by Sheira Schlair,
Sarah Moore, Michelle McMacken, and Melanie Jay for both groups with the printed leaflets
given to participants.
Participants will be offered the routine care of their presenting complaint. Blood pressure
will be measured at the beginning, at 8 weeks and at 16 week using an Omron blood pressure
with appropriate cuffs. Baseline assessment will include anthropometric measurements - height
(measured in bare feet to nearest 0.5 cm using a stadiometer) at the beginning of the study
only, weight (measured to nearest 0.1 kg), waist and neck circumferences will be measured
using a flexible measuring tape between the middle of the bottom rib (close to the navel) and
iliac crest and recorded to the nearest 0.1 cm. These measurements will be taken at the
beginning, at 8 weeks and at the end of the 16 weeks. Participants' phone numbers will be
collated for bulk text message reminders of exercise prescription.
3.85 Aspects only Common to Intervention Group Only At this juncture, the balloted envelop
will be opened and if participants belong to the SOME group, they will now have the Pedometer
app installed on their smartphones and calibrated with a 100 step test for sensitivity. They
will be shown how to use the application and instructed to keep their phones handy, charged
and chart their step count and monitor the increment. They will be a step count record card
with targets in slow increments to 10,000 steps per day.
3.86 Retention Efforts
Retention will be promoted by:
1. Examining and attempting to remove barriers (e.g., adjusting clinic hours)
2. Positive attitude and demeanor towards overweight and obesity with investigators
training in motivational methods and the sensitivity of obesity lingua. (Use "weight
problem" instead of "obesity")
3. Give incentives such as educational materials and web links to keep participants active
and give them ownership of the problem. They will also be an incentivizing prize for the
best 5 completers of the trial in terms of weight outcome.
4. The trial will make every effort to maintain contact with inactive participants via
phone, e-mail and text messaging to continue encouraging participants.
3.87 Follow up, Monitoring and Evaluation They shall be at least two follow ups per
participant during which further evaluations and weight measurement of primary and secondary
outcomes will be conducted. For comorbidities that require more frequent follow up, this will
be pursued to a logical conclusion.
3.9 Data Collection A pretested investigator administered data capture form will be used to
collect demographic data and baseline anthropometric and laboratory evaluation will be
conducted. participants will be given appropriate care and follow up. A further set of
evaluation will be obtained at 8 weeks and the end of the study.
4.1 Ethical Consideration Approval to conduct the study has been obtained from the Research
Ethics Committee of the National Hospital, Abuja and the study shall be conducted based on
good clinical practice principles and in conformity with the Declaration of Helsinki.
Written informed consent shall be obtained from each participant. No participant will be
coerced. Welfare, rights and confidentiality shall be guaranteed for all participants. Only
serial numbers will be allocated to participants and their names will not be entered into the
data capture forms. However, phone numbers will be required for adequate follow up.
Consultations and physical examination will be done in privacy with participants' caregiver
or a chaperone in attendance during physical examination. Undue discomfort will be avoided.
The issues of weight will be discussed in a sensitive manner and local cultures will be
respected during the study.
4.2 Data Analysis Data will be collected and collated in Microsoft Excel spreadsheet from
Windows Office Package Version 8. Data will then be exported and analyses will be conducted
using Statistical Package for the Social Sciences version 20.0 for Windows software with a p
value of <0.05 used to indicate statistically significant differences (V.20.0, 2010; SPSS,
Inc., Chicago, Illinois, USA). The data will be analyzed for normality and descriptively.
Data transformation will be conducted on data that are not normally distributed.
Descriptive statistics such as the mode, median, mean and standard deviation will be used to
analyze all demographic data and primary and secondary outcome variables. Independent t-tests
(for continuous data) and chi-square tests (for categorical data) will be used to compare at
baseline, the demographic and outcome variables between the two groups.
Two-way repeated-measures analysis of covariance will be conducted to compare the effects of
using a pedometer on the primary outcome measure. The intention-to-treat principle (last
observation carried forward) will be used to handle missing data resulting from dropout. In
addition, an independent t-test will be used to compare the average physical activity level
between the two groups.
4.4 Budget
1. Investigator's Assistants for data collection (x 4 assistants) 30,000.00 x 5=
N150,000.00
2. Fasting Blood Glucose investigation (at N400 per participant); N400 x 125= N50,000.00
3. Data for installation ( at N9,000.00 per month) N9,000.00 x 4 = N36,000.00
4. Photocopy of Study Materials (i.e. consent form, case report form, etc) = 100,000.00
GRAND TOTAL 340,000.00 NGA
