Obesity
Conditions
Keywords
Pregnancy, Maternal health, Newborn health, Information technology, Health education, Cellphone, Touch screen technology, Pregnancy outcome, Low-Middle income, Nurse-led, Nutrition, Exercise
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
Interventions
BEHAVIORALHEDUAfrica 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.
Sponsors
University of Cape Town
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| Improved awareness of food choices | 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. |
| 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 | — |
| To determine what women actually know (and how much they understand) about the risk factors during their pregnancy. | 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. |
Countries
South Africa
Contacts
Primary ContactKaren Sliwa, PhD
Outcome results
None listed