Smartphone Pedometers and Body Mass of Overweight and Obese Clients.
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

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.

      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
    

Intervention name(s): Smartphone Pedometer App
Intervention type(s): Device
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment