Pregnancy-Related Obesity Prevention Through Education & Communication Technology in AFRICA:The PROTECT-AFRICA STUDY
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- University of Cape Town
- Enrollment
- 1200
- Locations
- 2
- Primary Endpoint
- 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.
- Last Updated
- 10 years ago
Overview
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
Investigators
Prof. Karen Sliwa
Professor
University of Cape Town
Eligibility Criteria
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)
Outcomes
Primary Outcomes
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.
Time Frame: Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum
Secondary Outcomes
- 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)
- 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)
- Cost saving potential of intervention from a societal perspective.(September 2015)
- Apgar score >3(Newborn: Day of delivery)