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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03030534
First Posted: January 25, 2017
Last Update Posted: January 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Elizabeth M. Joseph-Shehu, University of KwaZulu
  Purpose

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

Condition Intervention
Health Behavior Combination Product: Educational package and software package Other: Health promotion tips

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants are assigned to two groups. that is two locations (study centres) will be selected for the study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Research Protocol On Developing an Integrated Technology-Moderated Institutional Health Promotion Model (ITIHPM)for Use in Nigeria Universities

Further study details as provided by Elizabeth M. Joseph-Shehu, University of KwaZulu:

Primary Outcome Measures:
  • Changes in Health promoting lifestyle practices [ Time Frame: Baseline, 6 weeks and 12 weeks ]
    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


Secondary Outcome Measures:
  • BMI in kg/m^2 [ Time Frame: Baseline, at 6 weeks and 12 weeks ]
    Assess changes in BMI

  • Random blood glucose in mg/dl [ Time Frame: Baseline, 6 weeks and 12 weeks ]
    Assess changes in participants blood glucose

  • Waist to Hip ratio (WHR) in cm [ Time Frame: Baseline, 6 weeks and 12 weeks ]
    Assess changes in Waist to Hip ratio

  • Blood pressure in mmHg [ Time Frame: Baseline, 6 weeks and 12 weeks ]
    Assess changes in participants blood pressure


Estimated Enrollment: 69
Study Start Date: October 2016
Estimated Study Completion Date: September 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Group
Educational Package and software package
Combination Product: Educational package and software package
Using Information and communication technology to deliver health promoting activities
Other Name: Health promotion lifestyle activities
Active Comparator: Control group
Health promotion tips
Other: Health promotion tips
Give general information on health promotion

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Unwilling to participate in the study
  • unable to use smartphone
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030534


Sponsors and Collaborators
University of KwaZulu
Investigators
Principal Investigator: Elizabeth M Joseph-Shehu, MSc University of KwaZulu-Natal, Durban, South Africa
  More Information

Additional Information:
Publications:
Responsible Party: Elizabeth M. Joseph-Shehu, Principal investigator, University of KwaZulu
ClinicalTrials.gov Identifier: NCT03030534     History of Changes
Other Study ID Numbers: DITIHPM-001
First Submitted: January 19, 2017
First Posted: January 25, 2017
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: All data that will be beneficial to other researchers will be sheared through journal publication and workshops. No identifying data will be published.