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

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

Study Overview

• Status: Unknown
• Conditions: Obesity
• Intervention / Treatment: Behavioral: HEDUAfrica IT package+ standard care

• Study Type: Interventional
• Enrollment (Anticipated): 1200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 1804
      • Recruiting
      • Elias Motsoaledi clinic
    • Johannesburg, Gauteng, South Africa, 1818
      • Recruiting
      • Senaoane Clinic
      • Contact: Sliwa; Email: karen.sliwa-hahnle@uct.ac.za

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: .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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
Apgar score >3		Newborn: Day of delivery
To determine what women actually know (and how much they understand) about the risk factors during their pregnancy.	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.	Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum
Improved awareness of food choices	A 24 hour recall dietary assessment will be administered to evaluate changes in food choice behaviour.	Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, 6 weeks postpartum
Cost saving potential of intervention from a societal perspective.		September 2015
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

Collaborators and Investigators

• Sponsor: University of Cape Town
• Investigators: Principal Investigator: Karen Sliwa, PhD, Hatter Institute for Cardiovascular Research in Africa (HICRA), University of Cape Town

Publications and helpful links

Helpful Links

• This is the official website for the Hatter Institute for Cardiovascular Research in Africa.
• This is the official website of the Soweto Cardiovascular Research Heart Unit.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: September 18, 2013
• First Submitted That Met QC Criteria: September 18, 2013
• First Posted (Estimate): September 23, 2013

Study Record Updates

• Last Update Posted (Estimate): August 14, 2015
• Last Update Submitted That Met QC Criteria: August 13, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Exercise; Pregnancy; Cellphone; Nutrition; Health education; Nurse-led; Maternal health; Information technology; Pregnancy outcome; Newborn health; Touch screen technology; Low-Middle income
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: PROTAF1402013