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

Obesity Clinical Trial

— PROTECT-AFRI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01948323
• Other study ID #: PROTAF1402013
• Status: Recruiting
• Phase: N/A
• First received: September 18, 2013
• Last updated: August 13, 2015
• Start date: September 2013
• Est. completion date: December 2015

Study information

• Verified date: August 2015
• Source: University of Cape Town
• Contact: Karen Sliwa, PhD
• Email: karen.sliwa-hahnle[@]uct.ac.za
• Is FDA regulated: No
• Health authority: South Africa: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity

Intervention

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.

Locations

Country	Name	City	State
South Africa	Elias Motsoaledi clinic	Johannesburg	Gauteng
South Africa	Senaoane Clinic	Johannesburg	Gauteng

Sponsors (1)

Lead Sponsor	Collaborator
University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Apgar score >3		Newborn: Day of delivery	No
Secondary	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	No
Secondary	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	No
Secondary	Cost saving potential of intervention from a societal perspective.		September 2015	No
Secondary	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	No

External Links

•   This is the health education website used in the intervention.
•   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.