Pregnancy-Related Obesity Prevention Through Education & Communication Technology in AFRICA:The PROTECT-AFRICA STUDY

NCT ID: NCT01948323

Last Updated: 2015-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this study is to investigate whether overweight but not obese pregnant African women having unlimited access to a health education-information technology (IT) based intervention package gain weight within the acceptable range of 8-12 kg during the pregnancy period.

Therefore, we hypothesize that unlimited access to health education via an IT-based intervention package has the potential to reduce the onset of obesity in African pregnant women.

To date (Aug 2015), 95% of patients have been recruited, 1320 potential subjects have been screened and 150 enrolled into the study

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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.HEDUAfrica IT package+ std care info

The HEDUAfrica IT package website aims to target disadvantaged gravid women representing the core aspect of the intervention. The website is available on a touch screen panel at the two intervention clinics, (Cape Town and Soweto, SA). A healthcare worker will assist women with the touchscreen tablet at the follow up sessions. The website content includes a number of short videos and health messages related to a pregnancy-specific-disease outcomes. Patients participating in the IT package also receive std car info

Participants are also asked to complete 2 questionnaires (24 hour dietary recall assessment and short messaging service technology driven) in conjunction to engaging with the HEDUAfrica website. The intervention is standardized across all participants in the intervention group.

Group Type OTHER

HEDUAfrica IT package+ standard care

Intervention Type BEHAVIORAL

The HEDUAfrica website aims to target disadvantaged pregnant women representing the core aspect of the intervention. The website is available on a touch screen panel at the two intervention clinics, (Cape Town and Soweto, South Africa). A trained healthcare worker will assist women by means of a touchscreen tablet at the follow up sessions. The website content includes a number of short videos and health messages related to a pregnancy-specific-disease outcomes.

Participants are also asked to complete 2 questionnaires (24 hour dietary recall assessment and short messaging service technology driven) in conjunction to engaging with the HEDUAfrica website. The intervention is standardized across all participants in the intervention group.

Health awareness brochure + std care

Participants in the non-intervention group at another clinic in Soweto, will receive an enhanced form of standard care. This will include, in conjunction with the normal form of care at each clinic,a health awareness brochure that will focus specifically on health information relating to obesity, diabetes, diet, exercise and breastfeeding at each follow-up sessions. These participants will also be asked to fill out the 24 hour dietary recall assessment and short messaging service technology questionnaire (exactly the same as the intervention group) with help from a healthcare worker.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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HEDUAfrica IT package+ standard care

The HEDUAfrica website aims to target disadvantaged pregnant women representing the core aspect of the intervention. The website is available on a touch screen panel at the two intervention clinics, (Cape Town and Soweto, South Africa). A trained healthcare worker will assist women by means of a touchscreen tablet at the follow up sessions. The website content includes a number of short videos and health messages related to a pregnancy-specific-disease outcomes.

Participants are also asked to complete 2 questionnaires (24 hour dietary recall assessment and short messaging service technology driven) in conjunction to engaging with the HEDUAfrica website. The intervention is standardized across all participants in the intervention group.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* body-mass index (BMI) range of 25.1-29.9 kg/m2
* Weeks of pregnancy: 16-20
* singleton pregnancy

Exclusion Criteria

* Evidence of pre-existing cardiovascular disease or a metabolic disorder (i.e. gestational diabetes)
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Cape Town

OTHER

Sponsor Role lead

Responsible Party

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Prof. Karen Sliwa

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen Sliwa, PhD

Role: PRINCIPAL_INVESTIGATOR

Hatter Institute for Cardiovascular Research in Africa (HICRA), University of Cape Town

Locations

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Elias Motsoaledi clinic

Johannesburg, Gauteng, South Africa

Site Status RECRUITING

Senaoane Clinic

Johannesburg, Gauteng, South Africa

Site Status RECRUITING

Countries

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South Africa

Central Contacts

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Karen Sliwa, PhD

Role: CONTACT

Facility Contacts

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Sliwa

Role: primary

Related Links

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http://www.socru.org

This is the official website of the Soweto Cardiovascular Research Heart Unit.

Other Identifiers

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PROTAF1402013

Identifier Type: -

Identifier Source: org_study_id

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