Pregnancy-Related Obesity Prevention Through Education & Communication Technology in AFRICA:The PROTECT-AFRICA STUDY
- Conditions
- Obesity
- Interventions
- Behavioral: HEDUAfrica IT package+ standard care
- Registration Number
- NCT01948323
- Lead Sponsor
- University of Cape Town
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 1200
- body-mass index (BMI) range of 25.1-29.9 kg/m2
- Weeks of pregnancy: 16-20
- singleton pregnancy
- Evidence of pre-existing cardiovascular disease or a metabolic disorder (i.e. gestational diabetes)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description .HEDUAfrica IT package+ std care info HEDUAfrica IT package+ standard care 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.
- Primary Outcome Measures
Name Time Method To determine a clinically significant difference (absolute difference of ≥10%) in the proportion of participants who gain > 12kg throughout study period will be less in the intervention group compared to the the non-intervention group. Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum
- Secondary Outcome Measures
Name Time Method Change in plasma Vitamin C levels in both the mother and newborn Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum; newborn: day of delivery, 6 weeks old, 12 weeks old Change in blood pressure profiles Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum; newborn: day of delivery, 6 weeks old, 12 weeks old Improved resting heart rate Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum; newborn: day of delivery, 6 weeks old, 12 weeks old Clinically normal C-reactive protein levels (<1 mg/dL) Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum; newborn: day of delivery, 6 weeks old, 12 weeks old Improved awareness of food choices Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, 6 weeks postpartum A 24 hour recall dietary assessment will be administered to evaluate changes in food choice behaviour.
Change in body composition (fat percentage, body water percentage, bone mass, muscle mass, bone density and visceral fat) of mother. Mother: Baseline (12-16 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum To determine what women actually know (and how much they understand) about the risk factors during their pregnancy. Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum Mobile intervention with text messages provide essential health information and encouragement to patients which may act as an effective strategy in preventing weight gain which will be assessed with a pre and post intervention questionnaire to evaluate whether the texts were understood and deemed beneficial by the patients.
Cost saving potential of intervention from a societal perspective. September 2015 Apgar score >3 Newborn: Day of delivery
Trial Locations
- Locations (2)
Elias Motsoaledi clinic
🇿🇦Johannesburg, Gauteng, South Africa
Senaoane Clinic
🇿🇦Johannesburg, Gauteng, South Africa