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Health BehaviorNCT03030534

Research Protocol On Developing an Integrated Technology-Moderated Institutional Health Promotion Model

A study testing Educational package and software package and Health promotion tips in people with Health Behavior, run by University of KwaZulu at 1 site in Nigeria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to adopt an operational research approach that seeks to design, develop and pilot-test the health-promotion lifestyle model that will enhance health-promoting behaviour and lifestyle modification of university staff in Nigeria. The following are the hypotheses of the study: 1. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Health Behavior
What is being tested?
Educational package and software package and Health promotion tips
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteNigeria
Study dates
15 Jan 2018to 9 Apr 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • All staff of the university in the selected study centres
  • Own a smartphone that can take the software application (experimental group)

Who cannot join

  • Unwilling to participate in the study
  • unable to use smartphone

Trial locations and contacts

1 site in 1 country.

Nigeria1 site
  • National Open University of Nigeria

    Abuja

Other trials in Nigeria

About this study

Official title: Research Protocol On Developing an Integrated Technology-Moderated Institutional Health Promotion Model (ITIHPM)for Use in Nigeria Universities

The purpose of this study is to adopt an operational research approach that seeks to design, develop and pilot-test the health-promotion lifestyle model that will enhance health-promoting behaviour and lifestyle modification of university staff in Nigeria. The following are the hypotheses of the study:

  1. There will be a significant difference in the pre and post intervention practices of health promoting lifestyle behaviours (behaviour specific cognition and affect) of NOUN staff
  2. There will be significant association between the health promoting lifestyle behaviours (behavioural outcome) and health status of NOUN staff
  3. There will be a significant difference in the pre-and post-intervention health promoting lifestyle behaviours (behavioural outcome) of staff of NOUN
  4. There will be a significant difference in the pre-and post-intervention health status measure (specific health measurement indicators) of staff of NOUN
Read the detailed description

Health promotion is advocated worldwide as being an efficient strategy to enhance quality of life and control the increasing prevalence of non-communicable diseases. health promoting lifestyle has been linked to high prevalence of most non-communicable diseases. Efficient and effective health promoting lifestyle practices is beneficial in prevention and control of non-communicable diseases, as well as improving the quality of life. World Health Organization has established workplace and schools as priority settings for health promotion in the 21st century as locus of reaching large number of audience. Workplace and schools also offer an ideal settings and infrastructure to support the health promoting activities that will improve the quality of life of workers and students. Information and communication technologies (ICTs) has made the world a global village, both young and old engages in one form of ICTs or the other. This study aims to adopt operational research approach to design, develop and pilot-test Integrated Technology-Moderated Institutional Health Promotion Model (ITIHPM) that will enhance health promoting behaviour and lifestyle modification of staff in Nigeria universities.

The objectives of the study are:

  1. To determine the health-promoting behaviour of NOUN staff;
  2. To assess the health status of NOUN staff;
  3. To examine factors that influence the health promoting lifestyle behaviour of NOUN staff;
  4. To assess institutional policies available to encourage NOUN staff to practise health -promoting lifestyles;
  5. To assess resources available in the institution that encourage health-promoting behavior;
  6. To examine protocols in place to ensure adoption of health-promoting behaviour and healthy lifestyle of NOUN staff;
  7. To determine technology-moderated applications/platforms that would be useful in promoting knowledge and skills acquisition for health-promoting behaviour and lifestyle modifications among NOUN staff; and
  8. To determine the impact of a technologically-based institutional health promotion model among NOUN staff.

Who can participate? All staff that are on the university pay roll in the selected study centres, irrespective of their age.

What does the study involve? Two study centres will be randomly selected from the six study centers selected during the first phase of the study. The two centres are randomly allocated into two groups two (experimental group and control group). The control group will receive tips on health promoting lifestyle practices, answer health promoting lifestyle profile questionnaire before giving the tips, have their weight, height, blood pressure, fasting blood sugar, abdominal circumference and hip circumference checked. The group will further answer the questionnaire and have their weight, height, blood pressure, fasting blood sugar, abdominal circumference and hip circumference checked at 6 weeks and at 12 weeks. While the experimental group will have four weeks training (educational package) on nutrition, exercise/physical activity, stress management, health responsibility, self-actualization and interpersonal relationship through seminar and symposium for 45-60 minutes 4 times in a week for the 4 weeks. At the beginning of the training database of all the participants will be created. This will include socio-demographic data and baseline health assessment that is related to the study (weight, height, blood pressure, fasting blood sugar, abdominal circumference and hip circumference). Participants will also answer questionnaire on health promoting lifestyle practice at the beginning of the training. The same procedure will be taken at week zero (immediately after the training), at 6 weeks and at 12 weeks. In the last two sections of the meeting, participants will be informed and intimate on the use of the software package and encourage them to ask questions. The participants will receive audio and video messages on health promoting lifestyle practices once in a week. The software application will be designed in a way that both the principal investigator and participants can interact at any time. The Technology-Moderated Institutional Health Promotion Model will also give opportunity to university staff to have assessed to a Community Health Nurse Specialist (health promotion expert) at every needed time. Four sessions of Focus Group Discussions among cohorts of staff will be conducted to identify barriers to healthy lifestyle practices using the developed model.

Primary outcome measures

  1. Health promoting lifestyle practices of staff will be measured using health promoting lifestyle profile II at the beginning of the study.
  2. Effective and efficient Health promoting lifestyle practices of staff will be measured using health promoting lifestyle profile II and mobile software application at zero week, 6 weeks and 12 weeks
  3. Health status of staff will be measured using the following indicators: weight, height, blood pressure, fasting blood sugar, abdominal circumference and hip circumference at the beginning of the study, at zero week, 6 weeks and 12 weeks
  4. Resources available in the university that will enhance health promoting lifestyle practices will be measured using interview guide and checklists at the beginning of the study Secondary outcome measures
  5. Participants compliance to the intervention will be measured at 6 weeks and 12 weeks 2. Participants satisfaction with the intervention will be measured at 6 weeks and 12 weeks 3. Retention rate will be measured at 6 weeks and 12 weeks

The target number of participants in the pilot-testing phase is 185 Exclusion criteria

What are the possible benefits and risks of participating? We hope that the study will afford the participants the benefits of practicing health promoting lifestyle effectively and thereby help him/her to prevent non-communicable diseases (NCDs). In case the participant has been diagnosed with any NCDs, participating in this study will provide the individual with relevant information that will make him/her live a quality life. During the study if the health assessment reveals any deviation from normal, the individual will be referred to the school sickbay for appropriate treatment and the principal researcher will still follow the him/her up. The only risk anticipated in this study is that its demands the participants to be meticulous in adhering to all the health promotion activities, which are beneficial on the long to the participants.

Conditions
Health Behavior
Being tested
Educational package and software package, Health promotion tips
Medical subject headings
Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational package and software packageCombination product

    Also called Health promotion lifestyle activities

    Using Information and communication technology to deliver health promoting activities

  • Health promotion tipsOther

    Give general information on health promotion

Study groups in NCT03030534
Study groupRoleWhat they receive
Experimental GroupExperimentalEducational Package and software package
Receives: Combination Product: Educational package and software package
Control groupActive comparatorHealth promotion tips
Receives: Other: Health promotion tips

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Health promoting lifestyle practices

    health promoting lifestyle profile questionnaire consist of six subclass (Nutrition, Physical activity, Health responsibility, Stress management, interpersonal relationship, self-actualization) of health promoting lifestyle activities and self-designed mobile software application

    Measured: Baseline, 6 weeks and 12 weeks

Secondary outcomes (4)
  1. BMI in kg/m^2

    Assess changes in BMI

    Measured: Baseline, at 6 weeks and 12 weeks

  2. Random blood glucose in mg/dl

    Assess changes in participants blood glucose

    Measured: Baseline, 6 weeks and 12 weeks

  3. Waist to Hip ratio (WHR) in cm

    Assess changes in Waist to Hip ratio

    Measured: Baseline, 6 weeks and 12 weeks

  4. Blood pressure in mmHg

    Assess changes in participants blood pressure

    Measured: Baseline, 6 weeks and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2017 (estimated)
  2. Study start15 Jan 2018
  3. Primary completion9 Apr 2018
  4. Study completion9 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Participants are assigned to two groups. that is two locations (study centres) will be selected for the study
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03030534
Sponsor's protocol ID
DITIHPM-001
Status last verified
Oct 2021
First submitted
19 Jan 2017
Last updated
25 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: All data that will be beneficial to other researchers will be sheared through journal publication and workshops. No identifying data will be published.

Publications

  • Şenol V, Ünalan D, Soyuer F, Argün M: The relationship between health promoting behaviors and quality of life in nursing home residents in Kayseri. Journal of Geriatrics 2014

  • Chronic diseases and health promotion: Global Status Report on NCDs

  • Oinas-Kukkonen H: Behavior change support systems: A research model and agenda. In: Persuasive Technology. edn.: Springer; 2010: 4-14.

  • Cowdery J, Kindred J, Michalakis A, Suggs LS: Promoting health in a virtual world: Impressions of health communication messages delivered in Second Life. First Monday 2011, 16(9).

  • Bock BC, Graham AL, Whiteley JA, Stoddard JL. A review of web-assisted tobacco interventions (WATIs). J Med Internet Res. 2008 Nov 6;10(5):e39. doi: 10.2196/jmir.989.

    PubMed 19000979
  • Koniak-Griffin D, Brecht ML, Takayanagi S, Villegas J, Melendrez M, Balcazar H. A community health worker-led lifestyle behavior intervention for Latina (Hispanic) women: feasibility and outcomes of a randomized controlled trial. Int J Nurs Stud. 2015 Jan;52(1):75-87. doi: 10.1016/j.ijnurstu.2014.09.005. Epub 2014 Sep 22.

    PubMed 25307195
  • Wikstrom K, Lindstrom J, Tuomilehto J, Saaristo TE, Helakorpi S, Korpi-Hyovalti E, Oksa H, Vanhala M, Keinanen-Kiukaanniemi S, Uusitupa M, Peltonen M. National diabetes prevention program (DEHKO): awareness and self-reported lifestyle changes in Finnish middle-aged population. Public Health. 2015 Mar;129(3):210-7. doi: 10.1016/j.puhe.2014.12.019. Epub 2015 Feb 26.

    PubMed 25726122

Questions about this trial

What is this clinical trial studying?

A study testing Educational package and software package and Health promotion tips in people with Health Behavior, run by University of KwaZulu at 1 site in Nigeria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Health promoting lifestyle practices (time frame: Baseline, 6 weeks and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03030534, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.

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Clinical Trial NCT03030534 | AzTrials