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

University of Cape Town (UCT)

Status: Unknown

Conditions: Obesity

Treatments: Behavioral: HEDUAfrica IT package+ standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT01948323

PROTAF1402013

Details and patient eligibility

About

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

Enrollment: 1,200 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,200 participants in 2 patient groups

.HEDUAfrica IT package+ std care info

Other group

Description:

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.

Treatment:

Behavioral: HEDUAfrica IT package+ standard care

Health awareness brochure + std care

No Intervention group

Description:

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.