Methods
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Study design: Randomized controlled trial |
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Unit of randomization: Individually randomised |
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Type of study: Obesity Prevention |
Participants
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Location/setting: Antenatal care clinic, Center for Social and Preventive Medicine (CSPM), Pediatrics Hospital, Cairo University, Egypt |
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Population: Not specified |
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Sample size: 147 |
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Drop outs/withdrawal:
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Total = 31 |
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Lost to follow‐up = 10 |
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Unable to contact = 6 |
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Exclusions = 15 (six due to miscarriage, four due to abortion and five due to stillbirth) |
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Socio‐demographics
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Age range: 20 to 30 years |
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Occupation:
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Intervention: n (%) |
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Housewife: 59 (73.7) |
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Working: 21 (26.3) |
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Control: n (%) |
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Housewife: 51 (63.7) |
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Working: 29 (36.3) |
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Race: Food Program |
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Education:
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Intervention: n (%) |
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Illiterate (read and write): 24 (30.1) |
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Basic education: 41 (51.2) |
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Secondary and higher education: 15 (18.7) |
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Control: n (%) |
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Illiterate (read and write): 26 (32.5) |
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Basic education: 33 (41.2) |
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Secondary and higher education: 21 (26.3) |
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Family income: Not specified |
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Inclusion criteria:
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Primigravidae aged between 20 and 30 years in their first trimester (<12 weeks of gestation) of pregnancy, attending the selected “Antenatal Care” clinic, free from history of any chronic medical problems were recruited to participate |
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Exclusion criteria:
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Women younger than 18 years (to avoid natural linear growth), having the history of previous abortion or stillbirth, presence of any chronic disease, and taking any type of medications that might interfere with the body weight (steroids, diuretics and thyroid hormones) |
Interventions
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Intervention (sample size):
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Received standard of care and attended six extra counselling session with a nutrition counsellor and fortnightly face‐to‐face appointments for a duration of 9 months. |
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Intervention was delivered through a nutrition counsellor. |
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(n = 75) |
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Control (sample size):
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Participants of the control group received the standard maternity care. Women in standard care attended their regularly scheduled visits for a duration of 9 months. |
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Intervention was delivered through a nutrition counsellor |
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(n = 72) |
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Training: Not specified |
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Follow‐up:
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Women received standard nutrition counselling provided by the physicians and nurses based on the Maternal and child Health Program components along with prenatal care from 28 weeks of gestation till delivery |
Outcomes
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Primary outcomes: Not specified |
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Secondary outcomes:
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Overweight |
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Maternal anaemia |
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Preterm birth |
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Macrosomia |
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Timing of outcome assessment: Not specified |
Notes
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Study start date: July 2015 |
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Study end date: April 2016 |
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Time period: 9 months |
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Study country: Egypt |
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Study limitations:
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Sizable amount of participants were illiterate, materials provided to illiterate participants were advised to get help from their educated spouse. Dropouts at end of study endorsed difficulty in follow‐up of the studied participants throughout the pregnancy until labour |
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Funding source: Not specified |
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Conflict of interest: Not specified |