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

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ClinicalTrials.gov Identifier: NCT01948323
Recruitment Status : Unknown
Verified August 2015 by Prof. Karen Sliwa, University of Cape Town.
Recruitment status was:  Recruiting
First Posted : September 23, 2013
Last Update Posted : August 14, 2015
Sponsor:
Information provided by (Responsible Party):
Prof. Karen Sliwa, University of Cape Town

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


Condition or disease Intervention/treatment Phase
Obesity Behavioral: HEDUAfrica IT package+ standard care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Pregnancy-Related Obesity Prevention Through Education & Communication Technology in AFRICA:The PROTECT-AFRICA STUDY
Study Start Date : September 2013
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : December 2015

Arm Intervention/treatment
.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.



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Apgar score >3 [ Time Frame: Newborn: Day of delivery ]
  6. To determine what women actually know (and how much they understand) about the risk factors during their pregnancy. [ Time Frame: Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum ]
    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.

  7. Improved awareness of food choices [ Time Frame: Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, 6 weeks postpartum ]
    A 24 hour recall dietary assessment will be administered to evaluate changes in food choice behaviour.

  8. Cost saving potential of intervention from a societal perspective. [ Time Frame: September 2015 ]
  9. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948323


Contacts
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Contact: Karen Sliwa, PhD karen.sliwa-hahnle@uct.ac.za

Locations
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South Africa
Elias Motsoaledi clinic Recruiting
Johannesburg, Gauteng, South Africa, 1804
Senaoane Clinic Recruiting
Johannesburg, Gauteng, South Africa, 1818
Contact: Sliwa       karen.sliwa-hahnle@uct.ac.za   
Sponsors and Collaborators
University of Cape Town
Investigators
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Principal Investigator: Karen Sliwa, PhD Hatter Institute for Cardiovascular Research in Africa (HICRA), University of Cape Town
Additional Information:
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Responsible Party: Prof. Karen Sliwa, Professor, University of Cape Town
ClinicalTrials.gov Identifier: NCT01948323    
Other Study ID Numbers: PROTAF1402013
First Posted: September 23, 2013    Key Record Dates
Last Update Posted: August 14, 2015
Last Verified: August 2015
Keywords provided by Prof. Karen Sliwa, University of Cape Town:
Pregnancy
Maternal health
Newborn health
Information technology
Health education
Cellphone
Touch screen technology
Pregnancy outcome
Low-Middle income
Nurse-led
Nutrition
Exercise
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight