Dietary and Lifestyle Interventions in Obese Pregnant Women
Primary Purpose
Obesity, Weight Gain, Lifestyle
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dietary and lifestyle intervention
Sponsored by
About this trial
This is an interventional prevention trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- gestational age between 6 and 12 weeks of gestation, pre-pregnancy≥28 (kg/m2)
- age ≥18 years, and a singleton pregnancy.
Exclusion Criteria:
- patients with prediabetes and diabetes, hypertension, chronic renal disease, thyroid disorder
- gestational weeks ≥ 13
- age <18 years
- multiple pregnancy
- uterine malformation
- or physical restriction that prevents exercise.
Sites / Locations
- Beijing Obstetrics and Gynecology Hospital,Capital Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Dietary and lifestyle intervention
Standard care group
Arm Description
Intervention group:Based on standard care,intensive dietary and lifestyle intervention was provided. Initiated from the first trimester to delivery,every 2-4 weeks follow-up
Standard care group:Participants received one group session in which prenatal general dietary, nutrition guideline, physical activity and recommendation for gestational weight gain introduced by a registered dietitian in 1.5hours.Participants received their regularly scheduled visits without additional dietary and lifestyle follow-up and guidance.
Outcomes
Primary Outcome Measures
Gestational weight gain
Secondary Outcome Measures
The incidence of gestational diabetes mellitus
The incidence of hypertensive disorders during pregnancy
The incidence of large-for-gestational-age infants
The incidence of macrosomia infants
The rate of caesarian section
Full Information
NCT ID
NCT02095028
First Posted
March 19, 2014
Last Updated
March 21, 2014
Sponsor
Capital Medical University
Collaborators
Ministry of Health, China
1. Study Identification
Unique Protocol Identification Number
NCT02095028
Brief Title
Dietary and Lifestyle Interventions in Obese Pregnant Women
Official Title
Effects of Dietary and Lifestyle Interventions in Obese Pregnant Women From the First Trimester on Gestational Weight Gain and Pregnancy Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University
Collaborators
Ministry of Health, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Background: Maternal obesity is associated with higher risks of adverse maternal and fetal complications, but the effects of dietary and lifestyle interventions on gestational weight gain(GWG) and pregnancy outcomes in obese pregnant women are unclear.
Objective: This study examined whether intensive dietary and lifestyle interventions initiated in the early pregnancy could decrease GWG, and prevent relevant adverse pregnancy outcomes in Chinese obese pregnant women.
Design:A randomized controlled trial in obese pregnant women was performed at 6-12 weeks of gestation.The sample size was estimated using GWG reduction as the primary outcome variable. The investigators pilot study (data not published) showed the gestational weight gain was 12.73±5.97 for obese women. Assuming intervention may result in 25% (3.1825g) reduction in GWG, the estimated sample size with 90% power and type I error of 0.05 was 114 women in intervention group and 57 in control group. Adjusting for 15% refusal or loss to follow up during pregnancy, the total sample size required was 136 women in intervention group and 68 in control group(standard care group). Participants were randomly assigned to the control or the intervention group. The intervention focused on restricting energy intake combined with behavioral lifestyle modification through participation in group sessions and individual counseling. The primary outcomes were gestational weight gain (GWG) and secondary outcomes were the incidence of gestational diabetes mellitus (GDM), hypertensive disorders during pregnancy, large-for-gestational-age (LGA) infants, macrosomia and the rate of caesarian section.
Hypothesis:The intensive dietary and lifestyle intervention performed from the first trimester in obese women could decrease total GWG,and perhaps improve relevant pregnancy outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Gain, Lifestyle, Pregnancy Related
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
373 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dietary and lifestyle intervention
Arm Type
Experimental
Arm Description
Intervention group:Based on standard care,intensive dietary and lifestyle intervention was provided. Initiated from the first trimester to delivery,every 2-4 weeks follow-up
Arm Title
Standard care group
Arm Type
No Intervention
Arm Description
Standard care group:Participants received one group session in which prenatal general dietary, nutrition guideline, physical activity and recommendation for gestational weight gain introduced by a registered dietitian in 1.5hours.Participants received their regularly scheduled visits without additional dietary and lifestyle follow-up and guidance.
Intervention Type
Behavioral
Intervention Name(s)
Dietary and lifestyle intervention
Intervention Description
participants in the intervention group were provided with an individualized dietary intake protocol. Patients received a diet of not fewer than 1500 calories per day in the first trimester and not fewer than 1800 calories per day after 13wks of gestation.
Primary Outcome Measure Information:
Title
Gestational weight gain
Time Frame
From enrollment to delivery (28-34 weeks of gestation)
Secondary Outcome Measure Information:
Title
The incidence of gestational diabetes mellitus
Time Frame
From enrollment to delivery (28-34 weeks of gestation)
Title
The incidence of hypertensive disorders during pregnancy
Time Frame
From enrollment to delivery (28-34 weeks of gestation)
Title
The incidence of large-for-gestational-age infants
Time Frame
From enrollment to delivery(28-34 weeks of gestation)
Title
The incidence of macrosomia infants
Time Frame
From enrollment to delivery (28-34 weeks of gestation)
Title
The rate of caesarian section
Time Frame
From enrollment to delivery(28-34 weeks of gestation)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
gestational age between 6 and 12 weeks of gestation, pre-pregnancy≥28 (kg/m2)
age ≥18 years, and a singleton pregnancy.
Exclusion Criteria:
patients with prediabetes and diabetes, hypertension, chronic renal disease, thyroid disorder
gestational weeks ≥ 13
age <18 years
multiple pregnancy
uterine malformation
or physical restriction that prevents exercise.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guanghui Li, MD,PhD
Organizational Affiliation
Beijing Obstetrics and Gynecology Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Obstetrics and Gynecology Hospital,Capital Medical University
City
Beijing
ZIP/Postal Code
100026
Country
China
12. IPD Sharing Statement
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Dietary and Lifestyle Interventions in Obese Pregnant Women
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