Clinical trial NCT01948323: Pregnancy-Related Obesity Prevention Through Education & Communication Technology in AFRICA:The PROTECT-AFRICA STUDY
Official title: Pregnancy-Related Obesity Prevention Through Education & Communication Technology in AFRICA:The PROTECT-AFRICA STUDY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Pregnancy
Maternal health
Newborn health
Information technology
Health education
Cellphone
Touch screen technology
Pregnancy outcome
Low-Middle income
Nurse-led
Nutrition
Exercise
Lead sponsor: University of Cape Town
Sponsor class: OTHER
First posted: 2013-09-23
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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)

Primary outcomes:
measure: 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.
timeFrame: Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum
Secondary outcomes:
measure: Change in plasma Vitamin C levels in both the mother and newborn
timeFrame: 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
measure: Change in blood pressure profiles
timeFrame: 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
measure: Improved resting heart rate
timeFrame: 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
measure: Clinically normal C-reactive protein levels (<1 mg/dL)
timeFrame: 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
measure: Apgar score >3
timeFrame: Newborn: Day of delivery
measure: To determine what women actually know (and how much they understand) about the risk factors during their pregnancy.
timeFrame: Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum
measure: Improved awareness of food choices
timeFrame: Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, 6 weeks postpartum
measure: Cost saving potential of intervention from a societal perspective.
timeFrame: September 2015
measure: Change in body composition (fat percentage, body water percentage, bone mass, muscle mass, bone density and visceral fat) of mother.
timeFrame: Mother: Baseline (12-16 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Elias Motsoaledi clinic
state: Gauteng
city: Johannesburg
country: South Africa
facility: Senaoane Clinic
state: Gauteng
Study officials:
affiliation: Hatter Institute for Cardiovascular Research in Africa (HICRA), University of Cape Town
name: Karen Sliwa, PhD
role: PRINCIPAL_INVESTIGATOR
References: