Effect of dietary and lifestyle intervention in pregnant women: randomized clinical trial

Lima, Maria Carolina de; Carreira, Natalia Posses; Sartorelli, Daniela Saes

doi:10.11606/s1518-8787.2025059006259

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Original Article • Rev. Saúde Pública 59 • 2025 • https://doi.org/10.11606/s1518-8787.2025059006259 linkcopy

Effect of dietary and lifestyle intervention in pregnant women: randomized clinical trial

Authorship SCIMAGO INSTITUTIONS RANKINGS

OBJECTIVE To evaluate the intra- and between-group (control and intervention) effect of counseling during pregnancy on pregnant women’s food consumption and physical activity.

METHODS This randomized, parallel, two-arm clinical trial was carried out in primary health care in a Brazilian municipality from 2018 to 2021. Adult pregnant women with pre-gestational overweight (n = 350) were randomly assigned to the control or intervention groups. The intervention consisted of three counseling sessions based on the NOVA food classification system and encouragement toward physical activity. Then, 24-hour dietary records were obtained, and physical activity was assessed using a structured questionnaire. The Wilcoxon test was used for intra-group differences between assessments and the Mann-Whitney test, for differences between groups.

RESULTS Women in the control group consumed less minimally and unprocessed foods (%E) (Δ = −4.08; -13.58 to 4.34; p = 0.006) and more ultra-processed foods (%E) (Δ = 3.74; −5.86 to 12.86; p = 0.009), with no difference between groups. The intervention group showed an increase in commuting-related physical activity (min/week) between assessments (Δ = 9.00; −30.00 to 70.00; p = 0.02), with no difference between groups. The other parameters showed no differences.

CONCLUSIONS The intervention failed to affect outcomes. However, intragroup changes showed that the control consumed less minimally and unprocessed foods and more ultra-processed foods and the intervention group increased their commuting-related physical activities.

DESCRIPTORS:
Pregnancy; Randomized Controlled Trial; NOVA Classification; Physical Activity; Diet

Characteristics	Intervention (n = 169)	Control (n = 166)	p^a
Characteristics	Median (P25; P75)		p^a
Maternal age, years	27 (23 to 31)	27 (22 to 32)	0.45
Gestational age at randomization, weeks	11 (9 to 13)	11 (9 to 12)	0.86
Baseline BMI, kg/m²	27.2 (26.2 to 28.3)	26.9 (25.9 to 28.4)	0.38
	n (%)
Married/cohabiting with partner	132 (78.1)	120 (72.3)	0.22
Self-reported skin color^b			0.91
White	50 (30.3)	53 (32.3)
Black	26 (15.8)	24 (14.6)
Brown/mixed race	89 (53.9)	87 (53.0)
Education, years			0.61
≤ 8	36 (21.3)	40 (24.1)
9–11	108 (63.9)	107 (64.5)
≥ 12	25 (14.8)	19 (11.4)
Socioeconomic stratum^c			0.39
A+B	32 (21.2)	31 (21.1)
C	98 (64.9)	87 (59.2)
D+E	21 (13.9)	29 (19.7)
Paid work at randomization	109 (64.5)	90 (54.2)	0.06
Nulliparous^d	56 (33.1)	66 (39.8)	0.33
Use of dietary supplements	152 (89.9)	148 (89.2)	0.82
Smoking habits			0.09
Never smoked	123 (72.8)	116 (69.9)
Currently smokes	7 (4.1)	17 (10.2)
Former smoker	39 (23.1)	33 (19.9)
Reported alcohol consumption in the last 30 days	31 (18.3)	34 (20.5)	0.62
Gestational diabetes mellitus^e	17 (12.9)	20 (14.1)	0.77
Pre-gestational hypertension^f	7 (4.2)	5 (3.0)	0.56

	Intervention^a	Control^a	p^b
	Median (P25; P75)	Median (P25; P75)	p^b
Unprocessed and minimally processed (%E)
1^st assessment	65.02 (57.34 to 72.60)	66.25 (58.32 to 72.69)	0.47
2^nd assessment	67.69 (55.06 to 75.29)	63.84 (53.14 to 73.98)	0.24
Δ	0.58 (−6.53 to 15.25)	−4.08 (−13.58 to 4.34)
p^c	0.35	0.006
Processed (%E)
1^st assessment	6.33 (4.06 to 9.13)	6.93 (4.44 to 10.14)	0.19
2^nd assessment	5.93 (2.91 to 8.85)	5.76 (3.17 to 8.64)	0.51
Δ	−1.57 (−4.83 to 2.70)	−1.24 (−3.50 to 2.32)
p^c	0.06	0.09
Ultra-processed (%E)
1^st assessment	25.47 (19.27 to 32.79)	24.17 (19.08 to 32.29)	0.71
2^nd assessment	25.69 (18.65 to 34.87)	26.75 (18.87 to 35.27)	0.69
Δ	2.00 (−7.84 to 11.25)	3.74 (−5.86 to 12.86)
p^c	0.37	0.009

	Intervention^a	Control^a	p^b
	Median (P25; P75)	Median (P25; P75)	p^b
CPA (min/week)
1^st assessment	56.00 (0.00 to 140.00)	60.00 (0.00 to 140.00)	0.48
2^nd assessment^e	60.00 (0.00 to 180.00)	40.00 (0.00 to 120.00)	0.17
Δ	9.00 (−30.00 to 70.00)	0.00 (−73.75 to 30.00)
p^c	0.02	0.08
LPA (min/week)
1^st assessment	0.00 (0.00 to 0.00)	0.00 (0.00 to 0.00)	0.83
2^nd assessment	0.00 (0.00 to 0.00)	0.00 (0.00 to 0.00)	0.14
Δ	0.00 (0.00 to 0.00)	0.00 (0.00 to 0.00)
p^c	0.42	0.50
CPA+LPA (min/week)
1^st assessment	60.00 (0.00 to 180.00)	70.00 (0.00 to 183.75)	0.48
2^nd assessment	80.00 (30.00 to 202.25)	60.00 (0.00 to 170.00)	0.17
Δ	5.00 (−30.00 to 70.00)	00.00 (−70.00 to 40.00)
p^c	0.08	0.40
Screen time (min/day)
1^st assessment^f	240.00 (120.00 to 412.50)	255.00 (180.00 to 420.00)	0.25
2^nd assessment^g	300.00 (180.00 to 480.00)	300.00 (165.00 to 420.00)	0.90
Δ	9.00 (−97.50 to 157.50)	−22.50 (−120.00 to 120.00)
p^c	0.16	0.82

	n (%)		p^d
≥ 150 min (CPA +LPA)/week
1^st assessment	40 (29.6)	48 (28.9)	0.89
2^nd assessment	35 (36.5)	31 (30.1)	0.34

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[1] Source: adapted from Sartorelli et al.¹⁵

[TFN1] ^a Student’s t-test or Mann-Whitney U test for continuous variables or the chi-squared test for categorical variables. ^b Self-reported skin color is used as a proxy for ethnicity in Brazil. Only five women reported being of Asian descent and one refused to answer. Analysis excluded them. No women reported being Indigenous.

[TFN2] ^c According to the Brazilian Economic Classification Criterion, which categorizes socioeconomic conditions from class A (highest level) to class E (lowest level). Data available for 151 women in the intervention group and 147 in the control group, as 37 were unaware of the household head’s education level.

[TFN3] ^d Data available for 169 women in the intervention group and 165 in the control group.

[TFN4] ^e Data available for 132 women in the intervention group and 142 in the control group.

[TFN5] ^f Data available for 167 women in the intervention group and 166 in the control group.