NCT07279337

Brief Summary

A high percentage of women are either overweight or obese before pregnancy and many women are exceeding the gestational weight gain recommendations when pregnant. Excessive gestational weight gain increases the risk of maternal and fetal complications. To help with this, women need to be advised about the appropriate weight gain recommendation according to their pre-pregnancy body weight. One way to do this is by receiving dietary and lifestyle advices during prenatal visits. This study will contribute to knowledge that will inform dietary guidelines and public policy on how to manage gestational weight gain and thus improve maternal and fetal outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
Last Updated

December 12, 2025

Status Verified

February 1, 2021

Enrollment Period

1.1 years

First QC Date

November 30, 2025

Last Update Submit

November 30, 2025

Conditions

Keywords

Nutrition, pregnancy, obesity, dietary intervention, gestational weight gain

Outcome Measures

Primary Outcomes (1)

  • Gestational weight gain

    Total weight gained during pregnancy

    6-8 months period

Secondary Outcomes (1)

  • adherence to IOM weight gain guidelines

    1 month

Study Arms (2)

nutrition counseling provided by licensed dietitians

EXPERIMENTAL

The intervention group participated in an initial 30-60-minute nutrition counseling session with a registered dietitian during the first trimester. Counseling emphasized balanced nutrition, limiting added sugars and unhealthy fats, and promoting whole foods. Individualized weight gain targets were set based on Institute of Medicine (IOM) guidelines of 2009: 6.8-11.4 kg for overweight women and 5-9 kg for women with obesity. Participants were also advised to engage in 150 minutes of moderate-intensity physical activity per week, as recommended by health guidelines. Follow-ups were conducted every 10-15 days via smartphone applications (e.g., WhatsApp, Zoom) with an average of 14 nutrition follow-ups throughout the intervention. The follow-ups were utilizing asynchronous telehealth platform that was secure and user-friendly.

Behavioral: Intervention group that received detailed nutrition assessment, counseling, and monitoring

Control group

NO INTERVENTION

Usual prenatal care

Interventions

The intervention group participated in an initial 30-60-minute nutrition counseling session with a registered dietitian during the first trimester. Counseling emphasized balanced nutrition, limiting added sugars and unhealthy fats, and promoting whole foods. Individualized weight gain targets were set based on Institute of Medicine (IOM) guidelines of 2009: 6.8-11.4 kg for overweight women and 5-9 kg for women with obesity. Participants were also advised to engage in 150 minutes of moderate-intensity physical activity per week, as recommended by health guidelines. Follow-ups were conducted every 10-15 days via smartphone applications (e.g., WhatsApp, Zoom) with an average of 14 nutrition follow-ups throughout the intervention. The follow-ups were utilizing asynchronous telehealth platform that was secure

nutrition counseling provided by licensed dietitians

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • In their first trimester of pregnancy
  • With a pre-pregnancy Body Mass Index (BMI) ranging from 25 to 35 kg/m², classifying them as overweight or obese.
  • Women were required to be attending regular prenatal care visits at randomly selected gynecology clinics
  • The ability and willingness to meet with a licensed dietitian for individualized counseling.
  • Commitment to follow the recommended nutrition and physical activity guidelines throughout the duration of the study

You may not qualify if:

  • Contraindications to exercise
  • Medical conditions such as uncontrolled hypertension, insulin-dependent diabetes, uncontrolled thyroid disease, multiple gestation, persistent bleeding in the first trimester
  • History of recurrent miscarriages.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lebanese International University

Beirut, Lebanon

Location

MeSH Terms

Conditions

OverweightObesityGestational Weight Gain

Interventions

Counseling

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsWeight GainBody Weight Changes

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University instructor and dietitian

Study Record Dates

First Submitted

November 30, 2025

First Posted

December 12, 2025

Study Start

February 1, 2021

Primary Completion

March 20, 2022

Study Completion

June 20, 2023

Last Updated

December 12, 2025

Record last verified: 2021-02

Locations