- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07279337
Effectiveness of Nutrition Counseling on Gestational Weight Gain Among Overweight and Obese Pregnant Women in Lebanon
Study Overview
Status
Conditions
Detailed Description
If you choose to participate in the suggested study, you will be seen by a dietitian during the first trimester for an in-depth counseling session and provide you with individualized nutrition counseling regarding your physical activity, dietary, and weight gain goals. You will then be asked to self-monitor your diet, weight, and physical activity. Study staff will instruct you on how to keep weekly paper logs of weight, activity, and diet that you will share with your dietitian weekly or biweekly by telephone. In order to determine the total gestational weight gain and to determine the impact of nutrition intervention on the health of your baby, data collectors will review your medical record to obtain your weight at delivery, your infants' birthweight, and method of delivery.
Apart from the 30 minutes of your time taken during the nutrition counseling session and your dietary and activity commitment according to the recommendations, we can expect no risks or inconveniences for you. Your participation in the study is voluntary and you may withdraw your participation from the study at any time. Your personal health information will be treated as confidential and all persons involved in the study are committed to respecting your privacy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Beirut, Lebanon
- Lebanese International University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: nutrition counseling provided by licensed dietitians
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. |
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 |
|
No Intervention: Control group
Usual prenatal care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gestational weight gain
Time Frame: 6-8 months period
|
Total weight gained during pregnancy
|
6-8 months period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
adherence to IOM weight gain guidelines
Time Frame: 1 month
|
comparing actual gestational weight gain to guidelines based on pre-BMI category
|
1 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nutrition Disorders
- Overnutrition
- Body Weight
- Body Weight Changes
- Weight Gain
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Gestational Weight Gain
- Overweight
- Obesity
- Health Services
- Health Care Facilities Workforce and Services
- Community Health Services
- Behavioral Disciplines and Activities
- Mental Health Services
- Counseling
Other Study ID Numbers
- LIUIRB-200706-JR1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Overweight and Obesity During Pregnancy
-
Minia UniversityCompletedObesity During Pregnancy in Clinical PracticeEgypt
-
Tokat Gaziosmanpasa UniversityThe Scientific and Technological Research Council of TurkeyCompletedObesity in Pregnancy | Maternal Comfort During Fetal MonitoringTurkey (Türkiye)
-
Arkansas Children's Hospital Research InstituteCompletedInflammation | Insulin Resistance | Childhood Obesity | Maternal Obesity During ChildbirthUnited States
-
Linkoeping UniversityCompletedMaternal Obesity During Childbirth | Labor; Arrested Active PhaseSweden
-
University of Modena and Reggio EmiliaUnknownExercise Addiction | Maternal Obesity Complicating Pregnancy | High-Risk Pregnancy | Inflammatory Status During Preganancy | Maternal Body CompositionItaly
-
Columbia UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedObesity | HIV | Maternal Obesity During Childbirth | Maternal Obesity Complicating Pregnancy | Obesity, InfantSouth Africa
-
Universiti Putra MalaysiaRecruitingEducational Materials (ST-NEPCO) During Nutrition Counselling for Obese ChildrenMalaysia
-
Mater Misericordiae University HospitalNot yet recruitingObesity (Disorder) | Pulmonary Aspiration During Anaesthetic Induction | Preoperative Risk Assessment | Gastric Emptying TimeIreland
-
Hvidovre University HospitalCompletedReduce the Risk of Obesity During Infancy | Reduce the Risk of Insulin ResistanceDenmark
-
Chinese University of Hong KongRecruitingHyperglycemia | Cardiovascular Diseases | Hypertension | Diabetes Mellitus | Overnutrition | Pregnancy | Gestational Diabetes Mellitus in Pregnancy | Maternal Obesity During ChildbirthHong Kong
Clinical Trials on Intervention group that received detailed nutrition assessment, counseling, and monitoring
-
Obafemi Awolowo UniversityCompleted
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)UnknownOvarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Clear Cell Adenocarcinoma | Ovarian Mucinous Adenocarcinoma | Fallopian Tube Transitional Cell Carcinoma | Ovarian Transitional Cell Carcinoma | Fallopian Tube Clear Cell Adenocarcinoma | Fallopian Tube Endometrioid Adenocarcinoma and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); Brander Beacons Cancer ResearchActive, not recruitingCancer Survivor | Stage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 and other conditionsUnited States
-
Ohio State University Comprehensive Cancer CenterAmerican Cancer Society, Inc.CompletedFeasibility Pilot Study | ComplianceUnited States
-
University of AlbertaActive, not recruiting
-
Ege UniversityRecruitingBreastfeeding, Exclusive | GrandmotherTurkey
-
Jonsson Comprehensive Cancer CenterSilicon Valley Community FoundationActive, not recruitingStage III Pancreatic Cancer | Pancreatic Adenocarcinoma Non-resectableUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingWeight Loss | Advanced Malignant Solid Neoplasm | Recurrent Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Cancer Fatigue | C-Reactive Protein MeasurementUnited States
-
Mayo ClinicRecruitingAdvanced Malignant Solid NeoplasmUnited States
-
Ohio State University Comprehensive Cancer CenterNational Institute on Aging (NIA)CompletedAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Stage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC... and other conditionsUnited States