ObesityPROTECT-AFRINCT01948323
Pregnancy-Related Obesity Prevention Through Education & Communication Technology in AFRICA:The PROTECT-AFRICA STUDY
A study of Obesity, run by University of Cape Town at 2 sites in South Africa.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 2 sitesSouth Africa
- Study dates
- Sep 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- body-mass index (BMI) range of 25.1-29.9 kg/m2
- Weeks of pregnancy: 16-20
- singleton pregnancy
Who cannot join
- Evidence of pre-existing cardiovascular disease or a metabolic disorder (i.e. gestational diabetes)
Trial locations and contacts
2 sites in 1 country.
Karen Sliwa, PhD contact
South Africa2 sites, 2 recruiting
- Recruiting
Elias Motsoaledi clinic
Johannesburg, Gauteng, 1804
- Recruiting
Senaoane Clinic
Johannesburg, Gauteng, 1818
Sliwa, karen.sliwa-hahnle@uct.ac.za
About this study
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
- Conditions
- Obesity
- Being tested
- HEDUAfrica IT package+ standard care
- Keywords
- Pregnancy, Maternal health, Newborn health, Information technology, Health education, Cellphone, Touch screen technology, Pregnancy outcome, Low-Middle income, Nurse-led, Nutrition, Exercise
- Medical subject headings
- Obesity, Health Education, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEDUAfrica IT package+ standard careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| .HEDUAfrica IT package+ std care info | Other | 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. Receives: Behavioral: HEDUAfrica IT package+ standard care |
| Health awareness brochure + std care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum
Secondary outcomes (9)
Change in plasma Vitamin C levels in both the mother and newborn
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, 6 weeks postpartum
Cost saving potential of intervention from a societal perspective.
Measured: September 2015
Change in body composition (fat percentage, body water percentage, bone mass, muscle mass, bone density and visceral fat) of mother.
Measured: Mother: Baseline (12-16 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Karen Sliwa, University of Cape Town
- Investigators
- Karen Sliwa, PhD, Principal investigator, Hatter Institute for Cardiovascular Research in Africa (HICRA), University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948323
- Sponsor's protocol ID
- PROTAF1402013
- Acronym
- PROTECT-AFRI
- Status last verified
- Aug 2015
- First submitted
- 18 Sep 2013
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy-Related Obesity Prevention Through Education & Communication Technology in AFRICA:The PROTECT-AFRICA STUDY
- ClinicalTrials.gov ID
- NCT01948323
- Acronym / sponsor ID
- PROTECT-AFRI / PROTAF1402013
- Conditions
- Obesity
- Keywords
- Pregnancy, Maternal health, Newborn health, Information technology, Health education, Cellphone, Touch screen technology, Pregnancy outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 23 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| .HEDUAfrica IT package+ std care info | Other | Behavioral: HEDUAfrica IT package+ standard careThe 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. |
| Health awareness brochure + std care | No intervention | –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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- body-mass index (BMI) range of 25.1-29.9 kg/m2
- Weeks of pregnancy: 16-20
- singleton pregnancy
Key exclusion criteria (1 listed)
- Evidence of pre-existing cardiovascular disease or a metabolic disorder (i.e. gestational diabetes)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEDUAfrica IT package+ standard careThe 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. | Behavioural | .HEDUAfrica IT package+ std care info |
Primary outcome
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
9 secondary outcomes
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
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
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
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
Apgar score >3
Time frame: Newborn: Day of delivery
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
Improved awareness of food choices
Time frame: Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, 6 weeks postpartum
Cost saving potential of intervention from a societal perspective.
Time frame: September 2015
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2015.
- This is the official website for the Hatter Institute for Cardiovascular Research in Africa.Link provided by the sponsor.
- This is the official website of the Soweto Cardiovascular Research Heart Unit.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Sliwa, PhD contact
Karen Sliwa, PhD principal investigator
Hatter Institute for Cardiovascular Research in Africa (HICRA), University of Cape Town
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Obesity, run by University of Cape Town at 2 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen Sliwa, PhD (karen.sliwa-hahnle@uct.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Mother: Baseline (16-20 weeks pregnancy), 24 weeks, 32 weeks, day of delivery, 6 weeks & 12 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2015.