Motivational Interviewing on Diet, Lifestyle and Gestational Weight Gain of Pregnant Women

NCT07635628 | Active Not Recruiting

• 1 other identifier: RC 07/24
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

It is widely recognized that nutrition, metabolism and physical activity during pregnancy play a central role in several aspects of the health and well-being of pregnant women and their offspring. Pre-pregnancy Body Mass Index (BMI) and Gestational Weight Gain (GWG) are important predictors of maternal and neonatal health outcomes. In particular, excessive maternal pre-pregnancy BMI (BMI ≥ 25) and GWG outside the range recommended by the Institute of Medicine (IOM), may put mothers at risk of complications during pregnancy and delivery and can affect the short and long-term health of the offspring. They are also predicting factors of postpartum weight retention and long-term risk of offspring overweight or higher BMI. Similarly to obesity, also maternal pre-pregnancy underweight can cause negative health effects with short and long-term consequences for the mother and the foetus. The most recent scientific evidence acknowledges the complex interplay between factors that influence the nutritional status and GWG of pregnant women, suggesting the need for multifaceted interventions that include counselling approaches, implemented during routine antenatal care for broad public health benefits. In particular, interventions based on health-related behavioural changes such as motivational interviewing (MI), used to address motivation, self-efficacy and self-regulation, have shown to have high chances of success. MI is a person-centred technique for communication that is effective for overcoming ambivalence and eliciting motivation for change. The starting hypothesis is that inadequate GWG at the end of pregnancy may bear some relation with dietary habits and lifestyle before and during pregnancy and that MI might be effective in initiating and sustaining behavioural changes, including weight control. The study will compare a group of pregnant women, randomly assigned to receive, as part of the hospital-based prenatal care program, a behavioral intervention based on the MI methodology focused on dietary habits and lifestyle, with a group of women randomly assigned to the standard prenatal care program. It is expected that the dietary habits of women in the MI group will change as a result of the intervention, and that the resulting effective management of weight gain during pregnancy will contribute to improved maternal and neonatal outcomes.

Conditions

Gestational Weight Gain

Keywords

Motivational interview; Gestational Weight Gain; Pregnancy; Lifestyle intervention

Outcome Measures

Primary Outcomes (1)

• Percentage of Women With Adequate Gestational Weight Gain According to Institute of Medicine Guidelines

  Gestational weight gain will be calculated as maternal weight at delivery minus self-reported pre-pregnancy weight. Adequate gestational weight gain will be defined according to the Institute of Medicine guidelines, based on pre-pregnancy body mass index category. The outcome will be reported as the percentage of women with gestational weight gain within the recommended range: number of women with adequate gestational weight gain / total number of women assessed x100

  At delivery

Secondary Outcomes (11)

• Gestational age at delivery

  At delivery

• Mode of delivery

  At delivery

• Newborn birth weight

  within 30 minute after birth

• Newborn birth length

  within 30 minute after birth

• Apgar Score at 1 Minute After Birth

  1 minutes after birth

Study Arms (2)

Experimental Group (EG)

EXPERIMENTAL

In addition to usual antenatal care (UC), the Experimental Group (EG) will receive four prenatal MI sessions between 11 and 15 weeks of gestation (T1), between 18 and 22 weeks (T2), between 24 and 28 weeks (T3), and between 30 and 34 weeks (T4).

Behavioral: Motivational Interview (MI)

Control Group (CG)

NO INTERVENTION

The Control Group (CG) will only receive the usual antenatal care (UC)

Interventions

Motivational Interview (MI) BEHAVIORAL

The four MI sessions, centered on eating habits, physical activity and lifestyle behaviours, will be led by a multidisciplinary group of health professionals - dieticians/nutritionists/ expert in motor sciences/psychologist - trained by a psychologist with expertise in MI. During the motivational sessions, personal barriers to behavioural change will be explored and positive verbal reinforcement will be given to increase self-confidence and self-efficacy. Women will be asked to identify the lifestyle behaviours they need to change and to set small stepwise goals based on their own intention to achieve a healthier lifestyle. Weight will be measured and GWG monitored at each of the four sessions.

Experimental Group (EG)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only pregnant women will be enrolled
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women \>=18 years, accessing hospital for the first scheduled ultrasound scan at 11-13 weeks of gestation and who express the intention of giving birth in the recruiting hospital

You may not qualify if:

• gestational age at enrollment \> 15 weeks
• preexisting type 1 diabetes
• multiple pregnancy
• insufficient knowledge of the Italian language.

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (1)

Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"

Trieste, 34137, Italy

Location

MeSH Terms

Conditions

Gestational Weight Gain

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Paola Pani, PhD

  Institute for Maternal and Child Health IRCCS Burlo Garofolo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled open-label superiority trial

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start: April 23, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

IT (1)