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

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
HEDUAfrica IT package+ standard care
Sponsored by
University of Cape Town
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Pregnancy, Maternal health, Newborn health, Information technology, Health education, Cellphone, Touch screen technology, Pregnancy outcome, Low-Middle income, Nurse-led, Nutrition, Exercise

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Elias Motsoaledi clinicRecruiting
  • Senaoane ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

.HEDUAfrica IT package+ std care info

Health awareness brochure + std care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in plasma Vitamin C levels in both the mother and newborn
Change in blood pressure profiles
Improved resting heart rate
Clinically normal C-reactive protein levels (<1 mg/dL)
Apgar score >3
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.
Improved awareness of food choices
A 24 hour recall dietary assessment will be administered to evaluate changes in food choice behaviour.
Cost saving potential of intervention from a societal perspective.
Change in body composition (fat percentage, body water percentage, bone mass, muscle mass, bone density and visceral fat) of mother.

Full Information

First Posted
September 18, 2013
Last Updated
August 13, 2015
Sponsor
University of Cape Town
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1. Study Identification

Unique Protocol Identification Number
NCT01948323
Brief Title
Pregnancy-Related Obesity Prevention Through Education & Communication Technology in AFRICA:The PROTECT-AFRICA STUDY
Acronym
PROTECT-AFRI
Official Title
Pregnancy-Related Obesity Prevention Through Education & Communication Technology in AFRICA:The PROTECT-AFRICA STUDY
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cape Town

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Pregnancy, Maternal health, Newborn health, Information technology, Health education, Cellphone, Touch screen technology, Pregnancy outcome, Low-Middle income, Nurse-led, Nutrition, Exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
.HEDUAfrica IT package+ std care info
Arm Type
Other
Arm Description
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.
Arm Title
Health awareness brochure + std care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HEDUAfrica IT package+ standard care
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Change in plasma Vitamin C levels in both the mother and newborn
Time Frame
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
Title
Change in blood pressure profiles
Time Frame
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
Title
Improved resting heart rate
Time Frame
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
Title
Clinically normal C-reactive protein levels (<1 mg/dL)
Time Frame
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
Title
Apgar score >3
Time Frame
Newborn: Day of delivery
Title
To determine what women actually know (and how much they understand) about the risk factors during their pregnancy.
Description
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.
Time Frame
Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum
Title
Improved awareness of food choices
Description
A 24 hour recall dietary assessment will be administered to evaluate changes in food choice behaviour.
Time Frame
Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, 6 weeks postpartum
Title
Cost saving potential of intervention from a societal perspective.
Time Frame
September 2015
Title
Change in body composition (fat percentage, body water percentage, bone mass, muscle mass, bone density and visceral fat) of mother.
Time Frame
Mother: Baseline (12-16 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Sliwa, PhD
Email
karen.sliwa-hahnle@uct.ac.za
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Sliwa, PhD
Organizational Affiliation
Hatter Institute for Cardiovascular Research in Africa (HICRA), University of Cape Town
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elias Motsoaledi clinic
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1804
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Senaoane Clinic
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1818
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sliwa
Email
karen.sliwa-hahnle@uct.ac.za

12. IPD Sharing Statement

Links:
URL
http://www.socru.org
Description
This is the official website of the Soweto Cardiovascular Research Heart Unit.

Learn more about this trial

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

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